Clinical Trials

Numerous clinical trials evaluate ledipasvir primarily for chronic hepatitis C virus infection across diverse presentations, including HIV coinfection, decompensated cirrhosis, and pediatric cohorts with hematologic malignancies. Spanning Early Phase 1 to Phase 4, these studies are supported by major industry sponsors like Gilead Sciences as well as academic medical centers such as Ain Shams University and the National Cancer Institute. With recruitment statuses ranging from completed to withdrawn or terminated, these key evaluations and pediatric pharmacokinetic analyses characterize the therapeutic efficacy, safety profile, and drug-interaction dynamics of ledipasvir-containing regimens.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03903185 COMPLETED
Hepatitis C, Chronic; Hematologic Malignancy
Ain Shams University
 2019-03-01 PHASE1; PHASE2
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
NCT02959359 WITHDRAWN
Hepatocellular Carcinoma
Taipei Veterans General Hospital, Taiwan
 2016-11 PHASE4
NCT02555943 COMPLETED
Chronic Hepatitis C Infection; HBV Coinfection; Hepatitis B Reactivation
Humanity and Health Research Centre
 2015-02 PHASE2; PHASE3
NCT03261349 UNKNOWN
Indolent Lymphoma
National Taiwan University Hospital
 2017-09-01 PHASE2
NCT04498936 COMPLETED
COVID
Assiut University
 2020-07-15 PHASE4
NCT02964091 COMPLETED
Chronic Hepatitis C
Partners in Health
 2016-10 PHASE4
NCT03312023 COMPLETED
Hepatitis B
University of Maryland, Baltimore
 2018-02-01 PHASE2
NCT02759861 COMPLETED
Genotype 1 Hepatitis C Virus
University of Nebraska
 2016-08-01 PHASE4
NCT04530422 COMPLETED
Covid19
Almaza Military Fever Hospital
 2020-04-15 PHASE3
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
NCT04457050 COMPLETED
Insulin Resistance; Hepatitis C
Alexandria University
 2017-10-30 PHASE4
NCT05091008 COMPLETED
Hepatitis C, Chronic
Mansoura University Children Hospital
 2018-03-01 PHASE2
NCT03126370 COMPLETED
Hepatitis C; HIV Coinfection
University of Colorado, Denver
 2018-01-08 PHASE4
NCT03764345 COMPLETED
Hepatitis C, Chronic; Children, Only
National Liver Institute, Egypt
 2018-12-06
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
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
NCT03903185 Completed
Hepatitis C Chronic|Hematologic Malignancy
Ain Shams University|Cairo University
 2019-03-01 Phase 1|Phase 2
NCT03961828 COMPLETED
Beta-Thalassemia; Hepatitis C
Tanta University
 2017-10-01 PHASE4
NCT02992457 COMPLETED
Hepatitis C
Tanta University
 2015-01 PHASE4
NCT03061032 UNKNOWN
Hepatitis C
Iran Hepatitis Network
 2017-03 PHASE3
NCT03036839 COMPLETED
Hepatitis C Virus Infection
Gilead Sciences
 2017-06-27 PHASE2
NCT02868242 COMPLETED
Hepatitis C Virus Infection
Gilead Sciences
 2016-08-28 PHASE2
NCT03343444 UNKNOWN
Hepatitis C Virus Infection, Response to Therapy of
Egyptian Liver Hospital
 2017-04-15 PHASE3
NCT03032666 COMPLETED
Thalassemia; Hepatitis C
Ala'a Sharara
 2017-05-01 PHASE4
NCT02249182 COMPLETED
Hepatitis C Virus Infection
Gilead Sciences
 2014-11-05 PHASE2
NCT02760355 COMPLETED
Insulin Resistance
University Hospital, Geneva
 2016-03
NCT03639207 Withdrawn
Hepatitis C Virus
National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC)
 2018-06-15 --
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
NCT05091008 Completed
Hepatitis C Chronic
Mansoura University Children Hospital
 2018-03-01 Phase 2
NCT03279133 WITHDRAWN
Hematopoietic Stem Cell Transplantation
Kaiser Permanente
 2017-09-01 PHASE4
NCT02660905 COMPLETED
Human Immunodeficiency Virus; Hepatitis C, Chronic
Ottawa Hospital Research Institute
 2016-04 PHASE3
NCT02576314 COMPLETED
Chronic Hepatitis C Infection
Humanity and Health Research Centre
 2015-05 PHASE3
NCT02771405 COMPLETED
Hepatitis C, Chronic; Hepatocellular Carcinoma
National Hepatology & Tropical Medicine Research Institute
 2016-03 PHASE3
NCT02707601 COMPLETED
HIV-1 Infection; HCV Infection
Gilead Sciences
 2016-04-01 PHASE3
NCT02705534 COMPLETED
Hepatitis C; Cirrhosis
Tehran University of Medical Sciences
 2016-09 PHASE3
NCT02503735 TERMINATED
Hepatitis C; Chronic Kidney Disease
Massachusetts General Hospital
 2015-07-15
NCT01958281 COMPLETED
HCV Infection
Gilead Sciences
 2013-10-07 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
NCT02717949 TERMINATED
Liver Disease
University of Texas Southwestern Medical Center
 2016-02-25 PHASE4
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
NCT03188276 COMPLETED
Chronic Hepatitis C
Third Affiliated Hospital, Sun Yat-Sen University
 2016-02-01 EARLY_PHASE1
NCT02600351 TERMINATED
Hepatitis C Virus Infection
Gilead Sciences
 2015-11-11 PHASE3
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
NCT02613871 COMPLETED
Hepatitis C Virus Infection
Gilead Sciences
 2015-12-22 PHASE3
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
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
NCT02309918 COMPLETED
Acute Hepatitis C
HepNet Study House, German Liverfoundation
 2014-11 PHASE2
NCT02339038 COMPLETED
HCV HIV
National Institutes of Health Clinical Center (CC)
 2015-01-07 PHASE4
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
NCT02472886 COMPLETED
Hepatitis C Virus Infection
Gilead Sciences
 2015-06-17 PHASE3
NCT02350569 COMPLETED
Hepatitis C Virus Infection
Gilead Sciences
 2015-05-22 PHASE2
NCT02251717 COMPLETED
Hepatitis C Virus Infection
Gilead Sciences
 2014-10-14 PHASE2
NCT02457611 COMPLETED
Hepatitis C Infection With HIV Co-Infection
Gilead Sciences
 2015-06 PHASE2
NCT02125500 COMPLETED
Viral Hepatitis C; HIV
ANRS, Emerging Infectious Diseases
 2014-08 PHASE2
NCT02413593 COMPLETED
Hepatitis C Virus Infection
Gilead Sciences
 2015-04 PHASE2
NCT02421211 COMPLETED
Hepatitis C, Chronic
Janssen Sciences Ireland UC
 2015-05-19 PHASE2
NCT01987453 COMPLETED
HCV Infection
Gilead Sciences
 2014-07 PHASE2
NCT02480387 COMPLETED
Treatment of Hepatitis C
Peter J. Ruane, M.D., Inc.
 2015-05 PHASE2
NCT02120300 COMPLETED
Chronic HCV Infection
Gilead Sciences
 2014-04 PHASE2
NCT01805882 COMPLETED
Hepatitis C, Chronic
National Institute of Allergy and Infectious Diseases (NIAID)
 2013-01 PHASE2
NCT02219685 COMPLETED
Hepatitis C Virus Infection
Gilead Sciences
 2014-08 PHASE2
NCT02010255 COMPLETED
Chronic HCV Infection
Gilead Sciences
 2014-01 PHASE2
NCT02226549 COMPLETED
Hepatitis C Virus Infection
Gilead Sciences
 2014-07 PHASE2
NCT01938430 COMPLETED
Chronic HCV Infection
Gilead Sciences
 2013-09 PHASE2
NCT02073656 COMPLETED
Hepatitis C Virus; HIV
Gilead Sciences
 2014-02 PHASE3
NCT02081079 COMPLETED
Chronic Genotype 4 HCV; Chronic Genotype 5 HCV
Gilead Sciences
 2014-03 PHASE2
NCT01878799 COMPLETED
Hepatitis C; HIV
National Institute of Allergy and Infectious Diseases (NIAID)
 2013-06 PHASE2
NCT01965535 COMPLETED
HCV Infection
Gilead Sciences
 2013-10 PHASE2
NCT01975675 COMPLETED
Chronic HCV Infection
Gilead Sciences
 2013-10 PHASE3
NCT01924949 COMPLETED
Hepatitis C
Gilead Sciences
 2013-07 PHASE2
NCT01984294 COMPLETED
Chronic HCV Infection
Gilead Sciences
 2013-10 PHASE2
NCT01701401 COMPLETED
Chronic Hepatitis C Virus
Gilead Sciences
 2012-09 PHASE3
NCT01851330 COMPLETED
Chronic Hepatitis C Virus
Gilead Sciences
 2013-05 PHASE3
NCT01768286 COMPLETED
Chronic Hepatitis C Virus
Gilead Sciences
 2013-01 PHASE3
NCT01726517 COMPLETED
Chronic Hepatitis C Virus
Gilead Sciences
 2012-10 PHASE2
NCT01384383 TERMINATED
Chronic Hepatitis C
Gilead Sciences
 2011-08 PHASE2
NCT01356160 COMPLETED
Hepatitis C, Chronic
Gilead Sciences
 2011-07 PHASE2
NCT01371578 COMPLETED
Hepatitis C, Chronic
Gilead Sciences
 2011-07 PHASE2
NCT01435226 COMPLETED
Hepatitis C, Chronic
Gilead Sciences
 2011-09 PHASE2
NCT01434498 COMPLETED
Chronic Genotype 1a or 1b HCV Infection
Gilead Sciences
 2011-09 PHASE2
NCT01353248 COMPLETED
Hepatitis C, Chronic
Gilead Sciences
 2011-05 PHASE2
NCT01193478 COMPLETED
HCV Infection
Gilead Sciences
 2010-08 PHASE1

(data from https://clinicaltrials.gov, updated on 2023-08-22)

Check the Ledipasvir (GS5885) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ledipasvir directly binds to the hepatitis C virus NS5A non-structural protein, disrupting the formation of the viral replication complex and inhibiting the hyperphosphorylation required for viral RNA synthesis. By arresting genomic replication and virion assembly at the cellular level, this potent inhibition prevents viral propagation and drives viral clearance in patients suffering from chronic hepatitis C virus infection.

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>).

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Note: Technical data last updated: Sep 1, 2026.