Numerous clinical trials have evaluated sofosbuvir from Phase 1 through Phase 4, focusing primarily on chronic hepatitis C virus infection across specialized populations—including pregnant and lactating individuals, pediatric cohorts, substance users, and kidney transplant recipients—as well as exploratory indications such as COVID-19. Funded by commercial, governmental, and academic sponsors, these studies span recruitment statuses from recruiting and active to completed or terminated.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07560046 | NOT_YET_RECRUITING | HIV - Human Immunodeficiency Virus; Hepatitis B Virus (HBV); HEPATITIS C (HCV) |
Duke University |
2026-08-01 | PHASE4 |
| NCT03855917 | RECRUITING | Hepatitis C |
Kirby Institute |
2020-02-11 | PHASE4 |
| NCT07793643 | NOT_YET_RECRUITING | HEPATITIS C (HCV) |
Patrick Grace |
2026-12-01 | PHASE4 |
| NCT06953479 | RECRUITING | HEPATITIS C (HCV); Incarceration; Injection Drug Use; Implementation Science |
Lifespan |
2025-06-11 | PHASE4 |
| NCT06159504 | RECRUITING | Hepatitis C; RDT |
Médecins du Monde |
2024-10-03 | EARLY_PHASE1 |
| NCT07037277 | ACTIVE_NOT_RECRUITING | HEPATITIS C VIRUS CHRONIC INFECTION; Hepatitis C, Chronic; Hepatitis C Virus Infection; Hepatitis C |
Atea Pharmaceuticals, Inc. |
2025-06-02 | PHASE3 |
| NCT06868264 | ACTIVE_NOT_RECRUITING | HEPATITIS C VIRUS CHRONIC INFECTION |
Atea Pharmaceuticals, Inc. |
2025-04-07 | PHASE3 |
| NCT05140941 | ACTIVE_NOT_RECRUITING | Hepatitis C, Chronic; Pregnancy; Infection |
Catherine Anne Chappell |
2022-04-04 | PHASE4 |
| NCT03222531 | COMPLETED | Hepatitis C; Heart Transplant; Cardiac Transplant |
Mary E. Keebler, MD |
2017-08-01 | PHASE2 |
| NCT03809533 | ACTIVE_NOT_RECRUITING | Kidney Transplantation; Hepatitis C |
Amit D Tevar, MD |
2019-05-29 | PHASE2 |
| NCT05992077 | ACTIVE_NOT_RECRUITING | HCV Infection |
ANRS, Emerging Infectious Diseases |
2023-08-07 | |
| NCT03646396 | UNKNOWN | HCV Coinfection |
Sherief Abd-Elsalam |
2018-08-01 | |
| NCT03949764 | COMPLETED | Hepatitis C; Opioid-Related Disorders; Injection Drug Use |
Jennifer Havens |
2019-09-23 | PHASE4 |
| NCT03819322 | COMPLETED | Liver Transplant; Hepatitis C |
Fernanda P Silveira, MD, MS |
2019-08-15 | PHASE2 |
| NCT06533319 | UNKNOWN | Hepatitis C |
Eastern Idaho Public Health |
2024-08-01 | |
| NCT03981211 | TERMINATED | Hepatitis C; Liver Inflammation; Liver Cirrhoses |
Kirby Institute |
2021-02-12 | |
| NCT07702396 | COMPLETED | Heptatitis C |
Indus Hospital and Health Network |
2024-01-10 | |
| NCT05717400 | TERMINATED | Liver Cancer |
M.D. Anderson Cancer Center |
2023-03-17 | PHASE4 |
| NCT05016609 | UNKNOWN | Hepatitis C |
Macfarlane Burnet Institute for Medical Research and Public Health Ltd |
2022-03-09 | PHASE4 |
| NCT05854511 | UNKNOWN | HCV |
Ain Shams University |
2022-06-05 | PHASE3 |
| NCT04885855 | COMPLETED | Hepatitis C |
Muhammad Radzi Abu Hassan |
2021-03-23 | PHASE2; PHASE3 |
| NCT04997564 | UNKNOWN | Chronic Hepatitis C; Chronic Hepatitis B |
Peking University First Hospital |
2021-08 | PHASE4 |
| NCT03086044 | UNKNOWN | Hepatitis C; Awaiting Organ Transplant |
Brigham and Women's Hospital |
2017-03-01 | PHASE4 |
| NCT05467826 | UNKNOWN | Hepatitis C; Cirrhosis |
Peking University People's Hospital |
2022-09-01 | PHASE4 |
| NCT05895448 | UNKNOWN | Chronic Hepatitis C; People Who Inject Drugs |
Center For Hepatitis C, Atlanta, GA |
2018-03-01 | PHASE4 |
| NCT04382404 | COMPLETED | Hepatitis C, Chronic |
Catherine Anne Chappell |
2020-10-22 | PHASE1 |
| NCT05992077 | Recruiting | HCV Infection |
ANRS Emerging Infectious Diseases |
2023-08-07 | Not Applicable |
| NCT03903185 | COMPLETED | Hepatitis C, Chronic; Hematologic Malignancy |
Ain Shams University |
2019-03-01 | PHASE1; PHASE2 |
| NCT03540212 | UNKNOWN | Chronic HCV Infection |
Ain Shams University |
2017-12-10 | PHASE2; PHASE3 |
| NCT04353986 | UNKNOWN | HCV Infection; Beta Thalassemia Major |
Ain Shams University |
2018-06-11 | PHASE3 |
| NCT03402165 | UNKNOWN | Hepatitis C |
Sherief Abd-Elsalam |
2017-01-01 | PHASE4 |
| NCT03444272 | UNKNOWN | Hepatitis C |
Sherief Abd-Elsalam |
2018-01-01 | PHASE3 |
| NCT05616598 | COMPLETED | Male Infertility; HCV |
Benha University |
2022-03-01 | PHASE2; PHASE3 |
| NCT03882307 | UNKNOWN | Hepatitis C, Chronic |
Assiut University |
2022-10 | EARLY_PHASE1 |
| NCT04653818 | COMPLETED | Hepatocellular Carcinoma; Hepatitis C; Neoplasm Recurrence; Treatment Complication |
Alexandria University |
2020-10-05 | PHASE4 |
| NCT02959359 | WITHDRAWN | Hepatocellular Carcinoma |
Taipei Veterans General Hospital, Taiwan |
2016-11 | PHASE4 |
| NCT05140941 | Recruiting | Hepatitis C Chronic|Pregnancy; Infection |
Catherine Anne Chappell|Gilead Sciences|University of Pittsburgh |
2022-04-04 | Phase 4 |
| NCT04561063 | COMPLETED | Covid19; SARS-CoV Infection |
University of Witwatersrand, South Africa |
2020-12-08 | PHASE2 |
| NCT03057847 | COMPLETED | Hepatitis C, Chronic; Opioid-use Disorder |
Elizabeth Krans, MD |
2018-01-30 | PHASE4 |
| NCT03492112 | COMPLETED | Hepatitis C |
Kirby Institute |
2019-09-10 | |
| NCT04695769 | COMPLETED | Chronic Hepatitis C |
Helwan University |
2020-11-21 | PHASE4 |
| NCT04532931 | COMPLETED | COVID-19 |
Shin Poong Pharmaceutical Co. Ltd. |
2020-09-03 | PHASE2 |
| NCT04460443 | UNKNOWN | COVID |
Tanta University |
2020-08-01 | PHASE2; PHASE3 |
| NCT02961426 | UNKNOWN | Hepatitis C |
Drugs for Neglected Diseases |
2016-09 | PHASE2; PHASE3 |
| NCT03818308 | COMPLETED | Hepatitis C; Acute Hepatitis C |
Hannover Medical School |
2019-05-28 | PHASE2 |
| NCT02939989 | COMPLETED | Hepatitis C Virus Infection |
AbbVie |
2016-11-21 | PHASE3 |
| NCT02555943 | COMPLETED | Chronic Hepatitis C Infection; HBV Coinfection; Hepatitis B Reactivation |
Humanity and Health Research Centre |
2015-02 | PHASE2; PHASE3 |
| NCT03801707 | COMPLETED | Kidney Transplant; Hepatitis C; HCV |
Ohio State University |
2019-03-22 | PHASE2; PHASE3 |
| NCT04535869 | UNKNOWN | COVID-19 |
Mansoura University |
2020-12-28 | PHASE3 |
| NCT04497649 | UNKNOWN | Covid19 |
Tanta University |
2020-07-01 | PHASE2; PHASE3 |
| NCT04112303 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2019-10-16 | PHASE3 |
| NCT03093740 | WITHDRAWN | Renal Failure Chronic; Hepatitis C |
Massachusetts General Hospital |
2018-10-01 | PHASE4 |
| NCT03261349 | UNKNOWN | Indolent Lymphoma |
National Taiwan University Hospital |
2017-09-01 | PHASE2 |
| NCT04039698 | UNKNOWN | Chronic Hepatitis C |
Hospital de Clinicas de Porto Alegre |
2019-08-23 | |
| NCT04358523 | COMPLETED | Healthy |
Ascletis Pharmaceuticals Co., Ltd. |
2020-03-20 | PHASE1 |
| NCT04852614 | Recruiting | Hepatitis C Virus Infection |
Ain Shams University |
2020-12-01 | -- |
| NCT03166943 | UNKNOWN | Hepatitis |
Assiut University |
2017-05-10 | |
| NCT03537196 | COMPLETED | Hepatitis C; Drug Use; Viral Hepatitis C |
ANRS, Emerging Infectious Diseases |
2018-11-13 | PHASE4 |
| NCT04773756 | COMPLETED | Covid19 |
Alexandria University |
2020-11-01 | PHASE4 |
| NCT04211909 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2020-01-03 | PHASE3 |
| NCT04773756 | Completed | Covid19 |
Alexandria University |
2020-11-01 | Phase 4 |
| NCT04498936 | COMPLETED | COVID |
Assiut University |
2020-07-15 | PHASE4 |
| NCT04443725 | UNKNOWN | COVID-19 |
Cairo University |
2020-07 | PHASE2; PHASE3 |
| NCT04382404 | Completed | Hepatitis C Chronic |
Catherine Anne Chappell|Gilead Sciences|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|University of Pittsburgh |
2020-10-22 | Phase 1 |
| NCT03236506 | COMPLETED | Hepatitis C |
University of Dundee |
2018-01-19 | PHASE2 |
| NCT02964091 | COMPLETED | Chronic Hepatitis C |
Partners in Health |
2016-10 | PHASE4 |
| NCT04202952 | COMPLETED | Chronic Hepatitis C |
Sunshine Lake Pharma Co., Ltd. |
2020-07-06 | PHASE1; PHASE2 |
| NCT03312023 | COMPLETED | Hepatitis B |
University of Maryland, Baltimore |
2018-02-01 | PHASE2 |
| NCT03883698 | COMPLETED | Kidney Failure, Chronic; Hepatitis C |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
2019-03-15 | PHASE3 |
| NCT02759861 | COMPLETED | Genotype 1 Hepatitis C Virus |
University of Nebraska |
2016-08-01 | PHASE4 |
| NCT03512210 | COMPLETED | Hepatitis C; HIV-1-infection; Liver Diseases |
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
2018-10-22 | PHASE4 |
| NCT03549312 | UNKNOWN | HIV-1-infection; Hepatitis C, Chronic; Methadone Dependence; Opioid Dependence; Bone Diseases, Metabolic; HIV/AIDS; Co-infection; Buprenorphine Dependence; HCV Coinfection |
Saskatchewan Health Authority - Regina Area |
2018-02-01 | PHASE4 |
| NCT04530422 | COMPLETED | Covid19 |
Almaza Military Fever Hospital |
2020-04-15 | PHASE3 |
| NCT03163849 | UNKNOWN | Chronic Hepatitis c |
Assiut University |
2019-09-01 | PHASE3 |
| NCT04111367 | UNKNOWN | Hepatitis C Virus Infection |
Ginkgopharma CO., LTD |
2019-04-03 | PHASE2 |
| NCT04246723 | COMPLETED | Chronic Hepatitis c Genotype 1 |
R-Pharm |
2019-05-06 | PHASE2 |
| NCT02683005 | COMPLETED | Hepatitis C; Pregnancy |
Catherine Chappell |
2016-09 | PHASE1 |
| NCT02836925 | COMPLETED | Indolent B-cell Lymphoma; Hepatitis C |
Fondazione Italiana Linfomi - ETS |
2016-03 | PHASE2 |
| NCT03112044 | ACTIVE_NOT_RECRUITING | Lung Transplant Infection; Hepatitis C |
University Health Network, Toronto |
2017-09-19 | EARLY_PHASE1 |
| NCT03313414 | WITHDRAWN | Hepatitis C |
Massachusetts General Hospital |
2019-08-13 | PHASE4 |
| NCT02533934 | COMPLETED | HIV; Hepatitis C; Cirrhosis |
University of California, San Francisco |
2016-08 | PHASE4 |
| NCT03619837 | COMPLETED | Hepatitis C; Transplantation Disease Transmission |
University of California, San Francisco |
2018-07-15 | PHASE4 |
| NCT03820258 | TERMINATED | Hepatitis C Virus Infection |
Gilead Sciences |
2019-01-28 | PHASE2 |
| NCT03022981 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2017-01-26 | PHASE2 |
| NCT04457050 | COMPLETED | Insulin Resistance; Hepatitis C |
Alexandria University |
2017-10-30 | PHASE4 |
| NCT04169464 | UNKNOWN | Egyptian Patients, HCV Treatment, Kidney Function |
MTI University |
2019-04-01 | PHASE4 |
| NCT02064049 | COMPLETED | Hepatitis C |
Kirby Institute |
2014-10 | PHASE4 |
| NCT02938013 | COMPLETED | HCV Coinfection; Liver Disease; HIV |
Johns Hopkins University |
2017-01 | PHASE4 |
| NCT03235154 | COMPLETED | Hepatitis C, Chronic; Hepatitis C; Opiate Dependence |
Community Research Initiative of New England |
2017-10-11 | PHASE4 |
| NCT05091008 | COMPLETED | Hepatitis C, Chronic |
Mansoura University Children Hospital |
2018-03-01 | PHASE2 |
| NCT04001608 | UNKNOWN | Hepatitis C Virus Infection |
Ginkgopharma CO., LTD |
2018-10-17 | PHASE3 |
| NCT03126370 | COMPLETED | Hepatitis C; HIV Coinfection |
University of Colorado, Denver |
2018-01-08 | PHASE4 |
| NCT02786537 | COMPLETED | Chronic Hepatitis C |
University of Florida |
2016-06 | PHASE4 |
| NCT03169348 | UNKNOWN | Hepatitis C |
Assiut University |
2017-11-01 | |
| NCT02858180 | COMPLETED | Hepatitis C, Chronic; Heart Failure; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial |
Duke University |
2016-12 | PHASE4 |
| NCT03706898 | COMPLETED | HIV-1-infection; Hepatic Impairment |
Viriom |
2018-10-01 | PHASE1 |
| NCT03721627 | UNKNOWN | Gaucher Disease; HCV |
Mansoura University Children Hospital |
2018-04-03 | PHASE4 |
| NCT03743727 | UNKNOWN | Hepatitis C Genotype 4 |
Yassin Abdelghaffar Charity Center for Liver Disease and Research |
2018-08-01 | PHASE4 |
| NCT03487107 | COMPLETED | Chronic HCV Infection |
Sunshine Lake Pharma Co., Ltd. |
2018-04-17 | PHASE3 |
| NCT03389061 | WITHDRAWN | HCV |
Radboud University Medical Center |
2018-04-01 | PHASE4 |
| NCT03549832 | COMPLETED | HCV Coinfection |
Assiut University |
2018-01-01 | |
| NCT03501550 | COMPLETED | Chronic Hepatitis C |
Cocrystal Pharma, Inc. |
2018-06-26 | PHASE2 |
| NCT03961828 | COMPLETED | Beta-Thalassemia; Hepatitis C |
Tanta University |
2017-10-01 | PHASE4 |
| NCT03092375 | COMPLETED | Hepatitis C; HCV |
University of Florida |
2017-04-20 | PHASE3 |
| NCT02992457 | COMPLETED | Hepatitis C |
Tanta University |
2015-01 | PHASE4 |
| NCT03061032 | UNKNOWN | Hepatitis C |
Iran Hepatitis Network |
2017-03 | PHASE3 |
| NCT02363517 | UNKNOWN | Hepatitis C; Drug Abuse, Intravenous |
Macfarlane Burnet Institute for Medical Research and Public Health Ltd |
2015-02 | PHASE3 |
| NCT03282474 | COMPLETED | Hepatitis E; Hepatitis Chronic Viral |
Hannover Medical School |
2017-12-07 | PHASE2 |
| NCT03036839 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2017-06-27 | PHASE2 |
| NCT02868242 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2016-08-28 | PHASE2 |
| NCT03480932 | COMPLETED | Hepatitis C, Chronic |
Johns Hopkins Bloomberg School of Public Health |
2018-02-02 | PHASE2; PHASE3 |
| NCT03343444 | UNKNOWN | Hepatitis C Virus Infection, Response to Therapy of |
Egyptian Liver Hospital |
2017-04-15 | PHASE3 |
| NCT02745535 | COMPLETED | Chronic Hepatitis C |
University of Maryland, Baltimore |
2016-05 | PHASE2 |
| NCT03487848 | TERMINATED | Hepatitis C; Chronic Hepatitis |
Bristol-Myers Squibb |
2018-06-25 | PHASE2 |
| NCT03296930 | UNKNOWN | Antiviral Drug Adverse Reaction |
Assiut University |
2017-10-01 | PHASE4 |
| NCT02994056 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2017-01-23 | PHASE2 |
| NCT02468648 | COMPLETED | Chronic Hepatitis C |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2015-06-09 | PHASE2 |
| NCT03063879 | COMPLETED | Hepatitis C, Chronic; Chronic Renal Failure |
Tehran University of Medical Sciences |
2017-04-01 | PHASE4 |
| NCT03369327 | COMPLETED | Hepatitis C Virus Infection, Response to Therapy of; Human Immunodeficiency Virus |
Tehran University of Medical Sciences |
2017-01-01 | PHASE3 |
| NCT03036852 | COMPLETED | Chronic Hepatitis C |
Gilead Sciences |
2017-03-22 | PHASE2 |
| NCT03032666 | COMPLETED | Thalassemia; Hepatitis C |
Ala'a Sharara |
2017-05-01 | PHASE4 |
| NCT02175758 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2014-07-07 | PHASE2 |
| NCT02249182 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2014-11-05 | PHASE2 |
| NCT02760355 | COMPLETED | Insulin Resistance |
University Hospital, Geneva |
2016-03 | |
| NCT02597166 | COMPLETED | Hepatitis C, Chronic; Cirrhosis, Decompensated |
University Health Network, Toronto |
2016-01 | PHASE3 |
| NCT02631772 | COMPLETED | Hepatitis C |
Medical University of South Carolina |
2016-06-01 | PHASE4 |
| NCT03490097 | COMPLETED | Chronic Hepatitis c; Metabolic Syndrome |
Ain Shams University |
2017-12-01 | PHASE2; PHASE3 |
| NCT03458481 | COMPLETED | Chronic HCV Infection |
Sunshine Lake Pharma Co., Ltd. |
2017-07-31 | PHASE2 |
| NCT03200184 | COMPLETED | Hepatitis C |
Tehran University of Medical Sciences |
2016-09-01 | PHASE4 |
| NCT03118843 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2017-04-25 | PHASE3 |
| NCT03080415 | COMPLETED | Hepatitis C Genotype 4 |
Yassin Abdelghaffar Charity Center for Liver Disease and Research |
2017-03-18 | PHASE3 |
| NCT03279133 | WITHDRAWN | Hematopoietic Stem Cell Transplantation |
Kaiser Permanente |
2017-09-01 | PHASE4 |
| NCT02996682 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2016-12-26 | PHASE3 |
| NCT03074331 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2017-03-23 | PHASE3 |
| NCT03995485 | COMPLETED | Hepatitis C, Chronic |
Kawin Technology Share-holding Co., Ltd. |
2017-06-07 | PHASE3 |
| NCT02728206 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2016-06-12 | PHASE2 |
| NCT02671500 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2016-04-19 | PHASE3 |
| NCT02660905 | COMPLETED | Human Immunodeficiency Virus; Hepatitis C, Chronic |
Ottawa Hospital Research Institute |
2016-04 | PHASE3 |
| NCT02804386 | COMPLETED | Hepatitis C, Chronic |
PharmEvo Pvt Ltd |
2016-06 | PHASE4 |
| NCT02482077 | COMPLETED | Chronic Hepatitis C Infection |
Humanity and Health Research Centre |
2015-01 | PHASE4 |
| NCT02473211 | COMPLETED | Chronic Hepatitis C Infection |
Humanity and Health Research Centre |
2015-01 | PHASE2; PHASE3 |
| NCT02576314 | COMPLETED | Chronic Hepatitis C Infection |
Humanity and Health Research Centre |
2015-05 | PHASE3 |
| NCT03105349 | WITHDRAWN | HCV |
Fundacion SEIMC-GESIDA |
2017-07-01 | PHASE4 |
| NCT02771405 | COMPLETED | Hepatitis C, Chronic; Hepatocellular Carcinoma |
National Hepatology & Tropical Medicine Research Institute |
2016-03 | PHASE3 |
| NCT04391985 | COMPLETED | Chronic Hepatitis C Virus Infection |
Beni-Suef University |
2017-03-01 | PHASE1; PHASE2 |
| NCT04387539 | COMPLETED | Chronic Hepatitis C Virus Infection |
Beni-Suef University |
2017-03-01 | PHASE1; PHASE2 |
| NCT02781558 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2016-07-29 | PHASE2 |
| NCT03416491 | COMPLETED | Hepatitis C, Chronic |
Kawin Technology Share-holding Co., Ltd. |
2017-02-15 | PHASE2 |
| NCT02707601 | COMPLETED | HIV-1 Infection; HCV Infection |
Gilead Sciences |
2016-04-01 | PHASE3 |
| NCT02503735 | TERMINATED | Hepatitis C; Chronic Kidney Disease |
Massachusetts General Hospital |
2015-07-15 | |
| NCT02705534 | COMPLETED | Hepatitis C; Cirrhosis |
Tehran University of Medical Sciences |
2016-09 | PHASE3 |
| NCT02304159 | COMPLETED | Hepatitis C; Cirrhosis |
Tarek I. Hassanein, M.D., FACP, FAG, AGAF |
2015-01 | PHASE4 |
| NCT02156570 | COMPLETED | Hepatitis C |
Kirby Institute |
2014-10 | PHASE4 |
| NCT02781571 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2016-07-27 | PHASE2 |
| NCT01958281 | COMPLETED | HCV Infection |
Gilead Sciences |
2013-10-07 | PHASE2 |
| NCT03250910 | COMPLETED | Hepatitis C Virus Infection, Response to Therapy of; Human Immunodeficiency Virus |
National Taiwan University Hospital |
2016-08-01 | PHASE4 |
| NCT02292719 | COMPLETED | Chronic Hepatitis C Virus Infection |
AbbVie |
2014-12-19 | PHASE2 |
| NCT02021656 | COMPLETED | Chronic HCV Infection |
Gilead Sciences |
2013-12-10 | PHASE3 |
| NCT02405013 | COMPLETED | Hepatitis C; HIV Infection |
ANRS, Emerging Infectious Diseases |
2015-10 | PHASE2 |
| NCT02722837 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2016-04-04 | PHASE3 |
| NCT02717949 | TERMINATED | Liver Disease |
University of Texas Southwestern Medical Center |
2016-02-25 | PHASE4 |
| NCT02822794 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2016-07-25 | PHASE3 |
| NCT02985281 | UNKNOWN | Pharmacological Action |
National Liver Institute, Egypt |
2016-12 | PHASE2; PHASE3 |
| NCT04387526 | COMPLETED | Chronic Hepatitis C Virus Infection |
Beni-Suef University |
2016-04-01 | PHASE2; PHASE3 |
| NCT04039958 | COMPLETED | Healthy |
Genuine Research Center, Egypt |
2017-04-05 | PHASE1 |
| NCT02768961 | COMPLETED | Hepatitis C |
Instituto de Investigación Marqués de Valdecilla |
2016-05-10 | PHASE4 |
| NCT02781649 | COMPLETED | End-Stage Renal Disease; Hepatitis C |
Johns Hopkins University |
2016-07-20 | PHASE4 |
| NCT03188276 | COMPLETED | Chronic Hepatitis C |
Third Affiliated Hospital, Sun Yat-Sen University |
2016-02-01 | EARLY_PHASE1 |
| NCT03186313 | COMPLETED | Hepatitis C |
Egyptian Liver Hospital |
2016-09 | PHASE3 |
| NCT02336139 | COMPLETED | Hepatitis C |
Kirby Institute |
2016-03-16 | PHASE2 |
| NCT02600351 | TERMINATED | Hepatitis C Virus Infection |
Gilead Sciences |
2015-11-11 | PHASE3 |
| NCT03453346 | COMPLETED | Hepatitis C, Chronic; Hepatitis C Virus Infection, Response to Therapy of |
Kawin Technology Share-holding Co., Ltd. |
2016-08-05 | |
| NCT02673489 | COMPLETED | Hepatitis C |
Bristol-Myers Squibb |
2016-03-15 | PHASE3 |
| NCT02624063 | COMPLETED | Hepatitis C, Chronic |
Federal University of São Paulo |
2015-12 | PHASE4 |
| NCT02128217 | COMPLETED | HIV-1 Infection; Hepatitis |
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
2014-05-30 | PHASE1 |
| NCT02738333 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2016-04-12 | PHASE3 |
| NCT02691728 | UNKNOWN | Chronic Hepatitis C |
Peter J. Ruane, M.D., Inc. |
2016-02 | PHASE4 |
| NCT02605304 | TERMINATED | HIV-1 Infection; Hepatitis C |
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
2016-02-17 | PHASE2 |
| NCT02723084 | COMPLETED | Chronic Hepatitis C Virus; Hepatitis C Virus |
AbbVie |
2016-04-08 | PHASE3 |
| NCT02613871 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2015-12-22 | PHASE3 |
| NCT02647632 | COMPLETED | Hepatitis C |
ANRS, Emerging Infectious Diseases |
2016-01 | PHASE2 |
| NCT02541409 | COMPLETED | Hepatitis C, Chronic |
Johns Hopkins Bloomberg School of Public Health |
2015-09 | PHASE2 |
| NCT02464631 | TERMINATED | HCV Related Cirrhosis |
Institute of Liver and Biliary Sciences, India |
2015-06 | |
| NCT02347345 | COMPLETED | Hepatitis C |
Rockefeller University |
2016-11-15 | PHASE4 |
| NCT02487030 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2015-09-07 | PHASE3 |
| NCT03005210 | COMPLETED | Healthy |
Genuine Research Center, Egypt |
2016-11 | PHASE1 |
| NCT02356562 | COMPLETED | Chronic Hepatitis C Infection |
AbbVie |
2015-02-03 | PHASE2 |
| NCT02601573 | COMPLETED | Hepatitis C |
Merck Sharp & Dohme LLC |
2016-01-05 | PHASE2 |
| NCT02639338 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2015-12-23 | PHASE3 |
| NCT02607800 | COMPLETED | Hepatitis C |
Gilead Sciences |
2015-11-16 | PHASE3 |
| NCT02607735 | COMPLETED | Hepatitis C |
Gilead Sciences |
2015-11-11 | PHASE3 |
| NCT02639247 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2015-12-23 | PHASE3 |
| NCT03062423 | COMPLETED | Healthy |
Genuine Research Center, Egypt |
2016-10 | PHASE1 |
| NCT02640157 | COMPLETED | Chronic Hepatitis C; Hepatitis C Virus; Genotype 3 Hepatitis C Virus |
AbbVie |
2015-12 | PHASE3 |
| NCT02480166 | COMPLETED | PT-NANBH |
Stanford University |
2015-06 | PHASE4 |
| NCT02638233 | UNKNOWN | Chronic Hepatitis C |
Wilhelminenspital Vienna |
2015-09 | PHASE4 |
| NCT02588287 | COMPLETED | Hepatitis C and HIV Coinfection |
University of Colorado, Denver |
2015-11 | |
| NCT02021643 | COMPLETED | Chronic HCV Infection |
Gilead Sciences |
2013-12-10 | PHASE3 |
| NCT02309918 | COMPLETED | Acute Hepatitis C |
HepNet Study House, German Liverfoundation |
2014-11 | PHASE2 |
| NCT02455167 | TERMINATED | Hepatitis C |
University of Colorado, Denver |
2015-05 | PHASE3 |
| NCT02300103 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2014-12-01 | PHASE2 |
| NCT04385407 | COMPLETED | Chronic Hepatitis C Virus Infection |
Beni-Suef University |
2015-04 | PHASE2 |
| NCT02339038 | COMPLETED | HCV HIV |
National Institutes of Health Clinical Center (CC) |
2015-01-07 | PHASE4 |
| NCT02551861 | WITHDRAWN | Hepatitis C |
Bristol-Myers Squibb |
2015-12 | PHASE2 |
| NCT02953535 | COMPLETED | Healthy |
Genuine Research Center, Egypt |
2016-05 | PHASE1 |
| NCT02556086 | WITHDRAWN | Hepatitis C |
Bristol-Myers Squibb |
2015-12 | PHASE2 |
| NCT02214420 | COMPLETED | Hepatitis C |
SC Liver Research Consortium, LLC |
2014-10 | PHASE4 |
| NCT03547895 | COMPLETED | Decompensated Cirrhosis |
Zagazig University |
2015-06-01 | |
| NCT02480712 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2015-07-01 | PHASE3 |
| NCT02301936 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2015-03-02 | PHASE2 |
| NCT02478229 | TERMINATED | Hepatitis C Viral Infection |
University Health Network, Toronto |
2015-06 | PHASE3 |
| NCT02596880 | COMPLETED | Hepatitis C; Cirrhosis |
Tehran University of Medical Sciences |
2015-09 | PHASE3 |
| NCT02472886 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2015-06-17 | PHASE3 |
| NCT02536313 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2015-07-29 | PHASE2 |
| NCT02350569 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2015-05-22 | PHASE2 |
| NCT02251717 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2014-10-14 | PHASE2 |
| NCT02346721 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2015-02-23 | PHASE3 |
| NCT02533427 | COMPLETED | HCV Infection |
Gilead Sciences |
2015-10-29 | PHASE1 |
| NCT03069001 | COMPLETED | HCV |
Ain Shams University |
2015-06 | PHASE4 |
| NCT02378935 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2015-02-17 | PHASE2 |
| NCT02349048 | COMPLETED | Hepatitis C Virus |
Janssen Research & Development, LLC |
2015-01 | PHASE2 |
| NCT02485080 | WITHDRAWN | PT-NANBH |
Stanford University |
2015-09 | PHASE4 |
| NCT02371408 | UNKNOWN | Chronic Hepatitis C |
Pharco Pharmaceuticals |
2015-01 | PHASE2; PHASE3 |
| NCT02457611 | COMPLETED | Hepatitis C Infection With HIV Co-Infection |
Gilead Sciences |
2015-06 | PHASE2 |
| NCT02253550 | COMPLETED | Chronic Hepatitis C |
Peter J. Ruane, M.D. |
2014-10 | PHASE2 |
| NCT02125500 | COMPLETED | Viral Hepatitis C; HIV |
ANRS, Emerging Infectious Diseases |
2014-08 | PHASE2 |
| NCT02250807 | COMPLETED | Chronic Hepatitis C; Genotype 4 Chronic Hepatitis C |
Janssen R&D Ireland |
2015-01 | PHASE3 |
| NCT02413593 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2015-04 | PHASE2 |
| NCT02702739 | COMPLETED | Liver Cirrhosis |
Azienda Ospedaliera San Camillo Forlanini |
2015-01 | PHASE4 |
| NCT02358044 | COMPLETED | Hepatitis C |
Merck Sharp & Dohme LLC |
2015-02-27 | PHASE3 |
| NCT02421211 | COMPLETED | Hepatitis C, Chronic |
Janssen Sciences Ireland UC |
2015-05-19 | PHASE2 |
| NCT02133131 | COMPLETED | Hepatitis C |
Merck Sharp & Dohme LLC |
2014-06-13 | PHASE2 |
| NCT02165189 | COMPLETED | Hepatitits C |
Janssen Scientific Affairs, LLC |
2014-08 | PHASE2 |
| NCT04382339 | COMPLETED | Hepatitis C Virus Infection |
Beni-Suef University |
2015-03 | PHASE1; PHASE2 |
| NCT01987453 | COMPLETED | HCV Infection |
Gilead Sciences |
2014-07 | PHASE2 |
| NCT02399345 | COMPLETED | Chronic Hepatitis C Virus (HCV Infection Genotype 1) |
AbbVie |
2015-03 | PHASE3 |
| NCT02480387 | COMPLETED | Treatment of Hepatitis C |
Peter J. Ruane, M.D., Inc. |
2015-05 | PHASE2 |
| NCT02278419 | COMPLETED | Hepatitis C |
Janssen-Cilag International NV |
2014-12 | PHASE2 |
| NCT02319031 | COMPLETED | Hepatitis C |
Bristol-Myers Squibb |
2015-02 | PHASE3 |
| NCT02378961 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2015-02-16 | PHASE2 |
| NCT02605798 | COMPLETED | Healthy |
Genuine Research Center, Egypt |
2015-08 | PHASE1 |
| NCT02206932 | WITHDRAWN | Hepatitis C, Chronic; HIV CDC Category A1 |
University of California, San Francisco |
2014-08 | PHASE4 |
| NCT02074514 | COMPLETED | Chronic HCV Infection |
Gilead Sciences |
2014-03 | PHASE3 |
| NCT02201953 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2014-07 | PHASE3 |
| NCT01532908 | TERMINATED | Hepatitis C Infection |
MassBiologics |
2012-11-21 | PHASE2 |
| NCT02262728 | COMPLETED | Hepatitis C, Chronic |
Janssen Research & Development, LLC |
2014-09-30 | PHASE2 |
| NCT01805882 | COMPLETED | Hepatitis C, Chronic |
National Institute of Allergy and Infectious Diseases (NIAID) |
2013-01 | PHASE2 |
| NCT02201901 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2014-07 | PHASE3 |
| NCT02220868 | COMPLETED | Hepatitis C Infection; HIV Infection |
Saint Michael's Medical Center |
2014-07 | PHASE4 |
| NCT02483156 | COMPLETED | Hepatitis c |
Egyptian Liver Hospital |
2015-07 | PHASE2; PHASE3 |
| NCT02120300 | COMPLETED | Chronic HCV Infection |
Gilead Sciences |
2014-04 | PHASE2 |
| NCT02219685 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2014-08 | PHASE2 |
| NCT02220998 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2014-09 | PHASE3 |
| NCT02128542 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2014-06 | PHASE4 |
| NCT02201940 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2014-07 | PHASE3 |
| NCT02010255 | COMPLETED | Chronic HCV Infection |
Gilead Sciences |
2014-01 | PHASE2 |
| NCT01826981 | COMPLETED | Chronic Hepatitis C |
Gilead Sciences |
2013-04 | PHASE2 |
| NCT02491450 | COMPLETED | Healthy |
Genuine Research Center, Egypt |
2015-02 | PHASE1 |
| NCT02226549 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2014-07 | PHASE2 |
| NCT02175966 | COMPLETED | Hepatitis C |
Bristol-Myers Squibb |
2014-07-28 | PHASE2 |
| NCT01962441 | COMPLETED | Hepatitis C |
Gilead Sciences |
2013-09-24 | PHASE3 |
| NCT02114151 | COMPLETED | Hepatitis C Virus Infection |
Janssen Infectious Diseases BVBA |
2014-04 | PHASE3 |
| NCT02114177 | COMPLETED | Hepatitis C Virus Infection |
Janssen Infectious Diseases BVBA |
2014-04 | PHASE3 |
| NCT01938430 | COMPLETED | Chronic HCV Infection |
Gilead Sciences |
2013-09 | PHASE2 |
| NCT02168361 | COMPLETED | Chronic Hepatitis C |
Center For Hepatitis C, Atlanta, GA |
2013-12 | PHASE4 |
| NCT02032875 | COMPLETED | Hepatitis C |
Bristol-Myers Squibb |
2014-03 | PHASE3 |
| NCT02081079 | COMPLETED | Chronic Genotype 4 HCV; Chronic Genotype 5 HCV |
Gilead Sciences |
2014-03 | PHASE2 |
| NCT02073656 | COMPLETED | Hepatitis C Virus; HIV |
Gilead Sciences |
2014-02 | PHASE3 |
| NCT02032888 | COMPLETED | Hepatitis C |
Bristol-Myers Squibb |
2014-02 | PHASE3 |
| NCT02032901 | COMPLETED | Hepatitis C |
Bristol-Myers Squibb |
2014-01 | PHASE3 |
| NCT01965535 | COMPLETED | HCV Infection |
Gilead Sciences |
2013-10 | PHASE2 |
| NCT01975675 | COMPLETED | Chronic HCV Infection |
Gilead Sciences |
2013-10 | PHASE3 |
| NCT01858766 | COMPLETED | Hepatitis C |
Gilead Sciences |
2013-04 | PHASE2 |
| NCT01559844 | COMPLETED | Hepatitis C; Hepatocellular Carcinoma |
Gilead Sciences |
2012-03 | PHASE2 |
| NCT01909804 | COMPLETED | Hepatitis C |
Gilead Sciences |
2013-06 | PHASE2 |
| NCT01924949 | COMPLETED | Hepatitis C |
Gilead Sciences |
2013-07 | PHASE2 |
| NCT01838590 | COMPLETED | Hepatitis C Virus |
Gilead Sciences |
2013-03 | PHASE3 |
| NCT01994486 | COMPLETED | Hepatitis C, Chronic |
University of Florida |
2013-12 | PHASE2 |
| NCT01984294 | COMPLETED | Chronic HCV Infection |
Gilead Sciences |
2013-10 | PHASE2 |
| NCT01783678 | COMPLETED | Chronic Hepatitis C; Human Immunodeficiency Virus |
Gilead Sciences |
2013-01 | PHASE3 |
| NCT01896193 | COMPLETED | Hepatitis C |
Gilead Sciences |
2013-06 | PHASE3 |
| NCT01910636 | COMPLETED | Hepatitis C |
Gilead Sciences |
2013-02 | PHASE3 |
| NCT01701401 | COMPLETED | Chronic Hepatitis C Virus |
Gilead Sciences |
2012-09 | PHASE3 |
| NCT01687270 | COMPLETED | Recurrent Chronic Hepatitis C Virus; Post Liver Transplant |
Gilead Sciences |
2012-11 | PHASE2 |
| NCT01851330 | COMPLETED | Chronic Hepatitis C Virus |
Gilead Sciences |
2013-05 | PHASE3 |
| NCT01768286 | COMPLETED | Chronic Hepatitis C Virus |
Gilead Sciences |
2013-01 | PHASE3 |
| NCT01713283 | COMPLETED | Hepatitis C Virus |
Gilead Sciences |
2012-10 | PHASE2 |
| NCT01808248 | COMPLETED | Hepatitis C |
Gilead Sciences |
2013-02 | PHASE2 |
| NCT01726517 | COMPLETED | Chronic Hepatitis C Virus |
Gilead Sciences |
2012-10 | PHASE2 |
| NCT01435044 | COMPLETED | Hepatitis C, Chronic |
Gilead Sciences |
2011-09 | PHASE2 |
| NCT01641640 | COMPLETED | Chronic Hepatitis C |
Gilead Sciences |
2012-06 | PHASE3 |
| NCT01497366 | COMPLETED | Hepatitis C |
Gilead Sciences |
2011-12 | PHASE3 |
| NCT01329978 | COMPLETED | Hepatitis C, Chronic |
Gilead Sciences |
2011-03 | PHASE2 |
| NCT01188772 | COMPLETED | Hepatitis C Virus |
Gilead Sciences |
2010-08 | PHASE2 |
| NCT01054729 | COMPLETED | Hepatitis C |
Gilead Sciences |
2010-01 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-05-05)
Check the
Sofosbuvir
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.