Entecavir has been evaluated across numerous clinical trials spanning Early Phase I through Phase IV, predominantly targeting chronic hepatitis B infection and advanced complications including liver cirrhosis, liver fibrosis, portal hypertension, and hepatitis B reactivation. Sponsored by diverse academic medical centers and commercial entities, these studies encompass recruiting, completed, terminated, and not yet recruiting operational statuses. This comprehensive research landscape underscores the ongoing effort to optimize antiviral therapeutic strategies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07345624 | NOT_YET_RECRUITING | Hepatitis B Virus Infection; Children; Chronic Hepatitis B |
Qing-Lei Zeng |
2026-01-11 | PHASE4 |
| NCT07345611 | NOT_YET_RECRUITING | Hepatitis B Virus Infection; Children; Chronic Hepatitis B |
Qing-Lei Zeng |
2026-01-11 | PHASE4 |
| NCT07493109 | RECRUITING | Diffuse Large B-Cell Lymphoma (DLBCL) |
Ou Bai, MD/PHD |
2026-05-30 | PHASE3 |
| NCT04942886 | ENROLLING_BY_INVITATION | Hepatitis B Reactivation; Hematopoietic Stem Cell Transplantation; Antiviral Drug; HBV |
Seoul St. Mary's Hospital |
2021-08-21 | |
| NCT07797231 | NOT_YET_RECRUITING | Chronic Hepatitis B |
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
2026-09 | PHASE3 |
| NCT05905172 | RECRUITING | Liver Fibrosis |
Beijing Continent Pharmaceutical Co, Ltd. |
2023-08-12 | PHASE3 |
| NCT07095855 | NOT_YET_RECRUITING | Chronic Hepatitis B |
Shanghai Zhimeng Biopharma, Inc. |
2025-08 | PHASE3 |
| NCT03933384 | RECRUITING | Hepatitis B; Viral Hepatitis |
Taichung Veterans General Hospital |
2019-08-19 | PHASE4 |
| NCT07267208 | NOT_YET_RECRUITING | Hepatitis B Virus; Liver Transplant |
Jongman Kim |
2025-12-01 | PHASE2 |
| NCT07253220 | NOT_YET_RECRUITING | Hepatitis B; Hepatocellular Carcinoma (HCC) |
Sun Yat-sen University |
2025-12-01 | |
| NCT07189377 | RECRUITING | Hepatitis B Virus (HBV); Lung Transplant Recipient |
University Health Network, Toronto |
2025-09-24 | PHASE4 |
| NCT06966232 | RECRUITING | Gastrointestinal Cancers |
Sun Yat-sen University |
2025-05-15 | PHASE3 |
| NCT05453435 | ACTIVE_NOT_RECRUITING | Resolved Hepatitis B; CD20 Positive B-cell Lymphoma |
Sun Yat-sen University |
2022-07-15 | PHASE2 |
| NCT07145268 | NOT_YET_RECRUITING | Liver Fibroses; HBV (Hepatitis B Virus) |
Tanta University |
2025-09-01 | PHASE2 |
| NCT07295873 | COMPLETED | Chronic Hepatitis B Liver Fibrosis; DDI (Drug-Drug Interaction) |
Beijing Continent Pharmaceutical Co, Ltd. |
2026-03-15 | PHASE1 |
| NCT04638439 | COMPLETED | Chronic Hepatitis B Infection; Chronic Hepatitis D Infection |
PharmaEssentia |
2022-08-17 | PHASE1 |
| NCT06150014 | ACTIVE_NOT_RECRUITING | Chronic Hepatitis b |
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
2023-12-07 | PHASE1; PHASE2 |
| NCT05793268 | ACTIVE_NOT_RECRUITING | Chronic Hepatitis b |
E-DA Hospital |
2022-12-20 | |
| NCT05550519 | WITHDRAWN | Hepatitis B, Chronic |
Janssen Pharmaceutica N.V., Belgium |
2022-10-31 | EARLY_PHASE1 |
| NCT06990776 | WITHDRAWN | Chronic Hepatitis B |
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
2025-07-09 | PHASE2 |
| NCT04536337 | COMPLETED | Chronic Hepatitis B |
Aligos Therapeutics |
2020-10-22 | PHASE1 |
| NCT06000657 | COMPLETED | Hepatitis B, Chronic |
Daewoong Pharmaceutical Co. LTD. |
2023-08-28 | PHASE4 |
| NCT03920618 | RECRUITING | Hepatitis B; Acute-On-Chronic Liver Failure |
Third Affiliated Hospital, Sun Yat-Sen University |
2019-02-21 | |
| NCT05721300 | UNKNOWN | Hepatocellular Carcinoma; Chronic Hepatitis B |
Zhongshan Hospital (Xiamen), Fudan University |
2023-02-10 | |
| NCT05115942 | COMPLETED | Liver Fibrosis |
Beijing Continent Pharmaceutical Co, Ltd. |
2021-12-30 | PHASE3 |
| NCT05404919 | WITHDRAWN | Lung Transplant; Hepatitis B |
University of Pennsylvania |
2022-09-06 | PHASE2 |
| NCT05382351 | UNKNOWN | Chronic Hepatitis B Virus Infection |
Sun Yat-sen University |
2022-05-10 | PHASE2 |
| NCT04195074 | UNKNOWN | Chronic Hepatitis b |
Third Affiliated Hospital, Sun Yat-Sen University |
2019-01-01 | |
| NCT04199819 | UNKNOWN | Occult Hepatitis B; Liver Transplant; Complications |
The University of Hong Kong |
2022-01-01 | |
| NCT05494528 | UNKNOWN | Chronic Hepatitis B Virus Infection |
National Taiwan University Hospital |
2021-05-04 | |
| NCT02650271 | COMPLETED | Hepatocellular Carcinoma |
Guangxi Medical University |
2021-02-02 | PHASE3 |
| NCT05275023 | COMPLETED | Hepatitis B, Chronic |
Janssen Research & Development, LLC |
2022-06-30 | PHASE2 |
| NCT04196998 | UNKNOWN | Hepatitis B; Compensated Cirrhosis |
Third Affiliated Hospital, Sun Yat-Sen University |
2019-01-01 | |
| NCT02849132 | UNKNOWN | Hepatitis B; Liver Cirrhosis |
Beijing Friendship Hospital |
2016-01 | PHASE4 |
| NCT05107778 | COMPLETED | Hepatitis B, Chronic |
Ascletis Pharmaceuticals Co., Ltd. |
2022-01-10 | PHASE2 |
| NCT05017116 | COMPLETED | Chronic Hepatitis B |
Suzhou Ribo Life Science Co. Ltd. |
2021-08-09 | PHASE1 |
| NCT04535544 | COMPLETED | Hepatitis D, Chronic |
Janssen Research & Development, LLC |
2020-09-17 | PHASE2 |
| NCT03084250 | UNKNOWN | Hepatitis B |
Shanghai Nanhui Nanhua Hospital |
2017-03-10 | PHASE4 |
| NCT05874440 | Recruiting | Chronic Hepatitis b Patients |
Sohag University |
2023-04-15 | -- |
| NCT05423106 | TERMINATED | Healthy; Hepatitis B, Chronic |
Janssen Research & Development, LLC |
2022-07-04 | PHASE1 |
| NCT04536532 | TERMINATED | Hepatitis B, Chronic |
Sunshine Lake Pharma Co., Ltd. |
2020-10-09 | PHASE1; PHASE2 |
| NCT04585789 | COMPLETED | Hepatitis B |
Janssen Research & Development, LLC |
2021-03-11 | PHASE2 |
| NCT05391360 | COMPLETED | Hepatitis B, Chronic |
Sunshine Lake Pharma Co., Ltd. |
2021-10-11 | PHASE1 |
| NCT05484466 | UNKNOWN | Hepatitis B, Chronic |
Shanghai Zhimeng Biopharma, Inc. |
2022-11-11 | PHASE2 |
| NCT03887702 | TERMINATED | Hepatitis B Infection; Malignant Solid Neoplasm |
SWOG Cancer Research Network |
2020-01-17 | PHASE3 |
| NCT04568265 | UNKNOWN | Hepatitis B; Chronic Hep B; HBV |
Ascentage Pharma Group Inc. |
2020-06-03 | PHASE2 |
| NCT04539119 | UNKNOWN | B-cell Lymphoma; HBV |
Ruijin Hospital |
2020-07-03 | PHASE3 |
| NCT04032860 | UNKNOWN | HCC; HBV Coinfection |
West China Hospital |
2017-07-01 | PHASE4 |
| NCT04147208 | COMPLETED | Chronic HBV Infection |
Sunshine Lake Pharma Co., Ltd. |
2019-02-28 | PHASE2 |
| NCT05453448 | COMPLETED | Antiviral Drugs |
Xiangya Hospital of Central South University |
2022-05-01 | |
| NCT04667104 | COMPLETED | Hepatitis B, Chronic |
Janssen Research & Development, LLC |
2021-02-01 | PHASE2 |
| NCT03357822 | UNKNOWN | Chronic Hepatitis B |
Tongji Hospital |
2018-01-25 | PHASE4 |
| NCT04501224 | UNKNOWN | Chronic Hepatitis b; Cirrhosis Due to Hepatitis B |
Third Affiliated Hospital, Sun Yat-Sen University |
2020-08-03 | |
| NCT04398134 | TERMINATED | Chronic Hepatitis B |
Assembly Biosciences |
2020-08-28 | PHASE2 |
| NCT03733652 | UNKNOWN | Chronic Hepatitis b; Efficacy, Self |
Third Affiliated Hospital, Sun Yat-Sen University |
2018-11-15 | |
| NCT04392700 | UNKNOWN | Hepatocellular Carcinoma Recurrent |
Sun Yat-sen University |
2019-07-25 | PHASE3 |
| NCT04129554 | COMPLETED | Hepatitis B, Chronic |
Janssen Sciences Ireland UC |
2019-11-06 | PHASE2 |
| NCT04182321 | COMPLETED | Chronic Hepatitis B |
Fu-Sheng Wang |
2020-03-13 | |
| NCT04465916 | TERMINATED | Hepatitis B, Chronic |
Enyo Pharma |
2020-05-12 | PHASE2 |
| NCT04365933 | COMPLETED | Hepatitis B, Chronic |
Enyo Pharma |
2020-05-25 | PHASE2 |
| NCT04034368 | UNKNOWN | HBV |
The First Hospital of Jilin University |
2019-08 | PHASE4 |
| NCT05687409 | COMPLETED | Cirrhosis, Liver; Metagonimiasis |
First Affiliated Hospital of Zhejiang University |
2019-11-24 | PHASE4 |
| NCT02555943 | COMPLETED | Chronic Hepatitis C Infection; HBV Coinfection; Hepatitis B Reactivation |
Humanity and Health Research Centre |
2015-02 | PHASE2; PHASE3 |
| NCT03241641 | COMPLETED | Chronic Hepatitis b |
Young-Suk Lim |
2017-10-26 | PHASE4 |
| NCT03905655 | COMPLETED | Chronic Hepatitis B |
Romark Laboratories L.C. |
2019-10-22 | PHASE2 |
| NCT03568578 | UNKNOWN | Hepatitis B; Liver Fibrosis |
Peking University First Hospital |
2018-01-28 | |
| NCT04405011 | UNKNOWN | HBV/HCV Co-infection |
National Taiwan University Hospital |
2018-08-01 | |
| NCT04157257 | UNKNOWN | Chronic Hepatitis b |
Qilu Pharmaceutical Co., Ltd. |
2019-07-26 | PHASE2 |
| NCT02499562 | COMPLETED | Hepatitis B, Chronic |
Shanghai Genomics, Inc. |
2015-06-25 | PHASE2 |
| NCT04454567 | Terminated | Chronic Hepatitis B |
Assembly Biosciences |
2020-11-11 | Phase 2 |
| NCT04180150 | UNKNOWN | Chronic Hepatitis B |
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
2019-11-18 | PHASE2 |
| NCT02945956 | UNKNOWN | Portal Hypertension |
ShuGuang Hospital |
2018-04-05 | PHASE4 |
| NCT02945982 | UNKNOWN | Portal Hypertension |
ShuGuang Hospital |
2018-04-05 | PHASE4 |
| NCT03062813 | UNKNOWN | Hepatitis B Virus Associated Nephrotic Syndrome |
Guangdong Provincial People's Hospital |
2017-02-01 | PHASE4 |
| NCT02263079 | COMPLETED | Pediatric Immuno-Tolerant Chronic Hepatitis B |
Hoffmann-La Roche |
2014-06-16 | PHASE3 |
| NCT03349008 | UNKNOWN | Chronic Hepatitis b; Liver Inflammation |
Cttq |
2017-11-25 | PHASE4 |
| NCT03308890 | UNKNOWN | Chronic Hepatitis B |
Taipei Veterans General Hospital, Taiwan |
2017-11-01 | PHASE4 |
| NCT04157257 | Unknown status | Chronic Hepatitis b |
Qilu Pharmaceutical Co. Ltd. |
2019-07-26 | Phase 2 |
| NCT03577171 | COMPLETED | Chronic Hepatitis B |
Assembly Biosciences |
2018-06-19 | PHASE2 |
| NCT04124081 | COMPLETED | Hydronidone |
Beijing Continent Pharmaceutical Co, Ltd. |
2019-05-15 | PHASE1 |
| NCT02241590 | UNKNOWN | Liver Cirrhosis Due to Hepatitis B Virus |
ShuGuang Hospital |
2014-09 | PHASE4 |
| NCT02241616 | UNKNOWN | Hepatitis B Virus Related Cirrhosis |
ShuGuang Hospital |
2014-09 | PHASE4 |
| NCT04069858 | UNKNOWN | Chronic Hepatitis B |
Korea University |
2016-12-01 | PHASE4 |
| NCT01907230 | UNKNOWN | Rheumatoid Arthritis; Hepatitis B Reactivation; Exposure to Hepatitis B Virus |
Taipei Veterans General Hospital, Taiwan |
2013-09-10 | PHASE4 |
| NCT03332329 | UNKNOWN | Chronic Hepatitis b |
Qin Ning |
2015-12-01 | PHASE4 |
| NCT03448744 | UNKNOWN | Chronic Hepatitis b |
Wen-hong Zhang |
2017-10-25 | PHASE4 |
| NCT03258710 | COMPLETED | Hepatitis B, Chronic |
GlaxoSmithKline |
2017-10-02 | PHASE4 |
| NCT03847246 | COMPLETED | Chronic Hepatitis b |
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
2018-12-04 | |
| NCT02505009 | COMPLETED | Chronic Hepatitis B |
Chang Gung Memorial Hospital |
2015-05-01 | PHASE4 |
| NCT02327416 | UNKNOWN | Hepatitis B, Chronic |
Tongji Hospital |
2014-10 | PHASE3 |
| NCT01925820 | UNKNOWN | Chronic Hepatitis B |
National Taiwan University Hospital |
2013-01 | PHASE4 |
| NCT02973646 | UNKNOWN | Chronic Hepatitis b |
Third Affiliated Hospital, Sun Yat-Sen University |
2016-01 | PHASE4 |
| NCT02615639 | UNKNOWN | Chronic Hepatitis B |
Third Affiliated Hospital, Sun Yat-Sen University |
2015-11 | PHASE1; PHASE2 |
| NCT02777814 | UNKNOWN | Colorectal Neoplasms |
Sun Yat-sen University |
2015-05-01 | PHASE2 |
| NCT03662568 | COMPLETED | Chronic Hepatitis B |
Sunshine Lake Pharma Co., Ltd. |
2018-06-26 | PHASE1 |
| NCT03272009 | COMPLETED | Hepatitis B, Chronic |
Enyo Pharma |
2017-09-21 | PHASE1 |
| NCT03236610 | UNKNOWN | Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48 |
Uijeongbu St. Mary Hospital |
2016-01-01 | PHASE3 |
| NCT03469583 | COMPLETED | Hepatitis B, Chronic |
Enyo Pharma |
2018-02-12 | PHASE1 |
| NCT02053727 | WITHDRAWN | Rheumatoid Arthritis; Chronic Hepatitis B |
University of California, Los Angeles |
2014-07 | |
| NCT02281266 | UNKNOWN | Curable Hepatitis B Virus-Related Hepatocellular Carcinoma |
Jia Fan |
2015-01 | PHASE4 |
| NCT03239353 | COMPLETED | HBV |
Aucta Pharmaceuticals, Inc |
2017-10-20 | PHASE1 |
| NCT02417207 | UNKNOWN | Hepatitis B; Liver Transplantation |
Third Affiliated Hospital, Sun Yat-Sen University |
2015-04 | PHASE4 |
| NCT03109730 | COMPLETED | Chronic Hepatitis B |
Assembly Biosciences |
2017-06-15 | PHASE1; PHASE2 |
| NCT02908191 | COMPLETED | Chronic Hepatitis B |
Assembly Biosciences |
2016-11 | PHASE1 |
| NCT01639092 | COMPLETED | Chronic Viral Hepatitis B Without Delta-agent |
Asan Medical Center |
2012-09-28 | PHASE4 |
| NCT03164889 | TERMINATED | Hepatitis B, Chronic |
Beijing 302 Hospital |
2017-01 | |
| NCT02097004 | COMPLETED | Hepatitis B, Chronic |
Seoul National University Hospital |
2014-04 | PHASE4 |
| NCT01765231 | UNKNOWN | Hepatitis B |
Peking University |
2013-01 | PHASE4 |
| NCT03509688 | COMPLETED | Hepatitis |
The First Hospital of Jilin University |
2014-11 | |
| NCT00931229 | UNKNOWN | Non-Hodgkin's Lymphoma |
National Health Research Institutes, Taiwan |
2009-06 | |
| NCT01768195 | UNKNOWN | Hepatitis B |
Peking University |
2013-01 | PHASE4 |
| NCT02777801 | UNKNOWN | Stomach Neoplasms |
Sun Yat-sen University |
2015-06 | PHASE2 |
| NCT02391805 | COMPLETED | Hepatitis B, Chronic |
Hoffmann-La Roche |
2015-05-17 | PHASE2 |
| NCT02496897 | COMPLETED | Hepatitis B |
Altimmune, Inc. |
2015-07 | PHASE1 |
| NCT03018821 | UNKNOWN | Hepatitis B， Chronic |
Xi'an Traditional Medicine Hospital |
2017-01 | |
| NCT01639066 | COMPLETED | Chronic Viral Hepatitis B Without Delta-agent |
Asan Medical Center |
2012-09-25 | PHASE4 |
| NCT03032536 | TERMINATED | Hepatitis B; Chronic Hepatitis B; Viral Hepatitis B |
Alios Biopharma Inc. |
2017-01-31 | PHASE1 |
| NCT01580202 | COMPLETED | Malignancy; Hepatitis B |
Seoul National University Hospital |
2012-04 | PHASE3 |
| NCT01369199 | TERMINATED | Hepatitis B |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2012-05 | PHASE3 |
| NCT02065336 | TERMINATED | Hepatitis B, Chronic |
Arrowhead Pharmaceuticals |
2014-03 | PHASE2 |
| NCT02604199 | TERMINATED | Hepatitis B |
Arrowhead Pharmaceuticals |
2015-09 | PHASE2 |
| NCT02482272 | UNKNOWN | Hepatitis B, Chronic |
Asan Medical Center |
2015-05 | PHASE4 |
| NCT01918631 | COMPLETED | Chronic Heptitis B |
Chinese University of Hong Kong |
2013-08 | |
| NCT01368497 | COMPLETED | Hepatitis B |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2012-09 | PHASE3 |
| NCT01938781 | COMPLETED | Liver Fibrosis |
Beijing Friendship Hospital |
2013-06 | PHASE4 |
| NCT02738008 | TERMINATED | Hepatitis B |
Arrowhead Pharmaceuticals |
2016-03 | PHASE2 |
| NCT02360592 | COMPLETED | Hepatitis B, Chronic |
Tongji Hospital |
2013-06 | PHASE4 |
| NCT02365402 | UNKNOWN | Chronic Hepatitis B |
Beijing Ditan Hospital |
2013-01 | PHASE4 |
| NCT02577029 | TERMINATED | Hepatitis B; Hepatitis D |
Arrowhead Pharmaceuticals |
2015-12 | PHASE2 |
| NCT01938820 | COMPLETED | Liver Cirrhosis |
Beijing Friendship Hospital |
2013-06 | PHASE4 |
| NCT02604212 | TERMINATED | Hepatitis B |
Arrowhead Pharmaceuticals |
2015-11 | PHASE2 |
| NCT02452528 | TERMINATED | Chronic Hepatitis B |
Arrowhead Pharmaceuticals |
2015-08 | PHASE2 |
| NCT02368288 | UNKNOWN | Chronic Hepatitis B |
Beijing Ditan Hospital |
2013-01 | PHASE4 |
| NCT01943617 | COMPLETED | Liver Cirrhosis |
Beijing Friendship Hospital |
2013-06 | PHASE4 |
| NCT02797522 | TERMINATED | Hepatitis B |
Arrowhead Pharmaceuticals |
2016-06 | PHASE1 |
| NCT02726789 | COMPLETED | Hepatitis B, Chronic |
Replicor Inc. |
2012-10 | PHASE2 |
| NCT02560649 | UNKNOWN | Chronic Hepatitis B |
Ruijin Hospital |
2015-05 | PHASE4 |
| NCT02532413 | UNKNOWN | Chronic Hepatitis B |
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
2015-07 | PHASE4 |
| NCT01906580 | UNKNOWN | Chronic Hepatitis B |
Beijing 302 Hospital |
2011-07 | PHASE4 |
| NCT01834508 | UNKNOWN | Chronic Hepatitis B |
Nanfang Hospital, Southern Medical University |
2013-03 | PHASE4 |
| NCT01829685 | UNKNOWN | Chronic Hepatitis B; Inadequate Response; Nucleos(t)Ide Analogues Treatment |
Nanfang Hospital, Southern Medical University |
2013-03 | PHASE4 |
| NCT01627223 | TERMINATED | Chronic Hepatitis B |
Taichung Veterans General Hospital |
2012-07 | PHASE4 |
| NCT01456312 | UNKNOWN | Hepatitis B, Chronic |
Gangnam Severance Hospital |
2012-09 | PHASE4 |
| NCT02850848 | COMPLETED | Hepatitis B |
Yung Shin Pharm. Ind. Co., Ltd. |
2015-12 | PHASE4 |
| NCT02829359 | COMPLETED | Liver Cancer |
Guangxi Medical University |
2012-07 | PHASE2; PHASE3 |
| NCT01914744 | UNKNOWN | Non-Hodgkin Lymphoma; Hepatitis B Reactivation |
Fudan University |
2013-02 | PHASE2 |
| NCT01711567 | COMPLETED | Chronic Hepatitis B |
Korea University |
2013-04 | PHASE4 |
| NCT01694264 | TERMINATED | Chronic Hepatitis B; Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis; Juvenile Idiopathic Arthritis |
Seoul National University Hospital |
2012-09-01 | PHASE3 |
| NCT01894269 | UNKNOWN | Hepatocellular Carcinoma |
Sun Yat-sen University |
2013-07 | PHASE4 |
| NCT01217632 | TERMINATED | Liver Fibrosis Due to Chronic Hepatitis B Infection |
Kyntra Bio |
2010-08 | PHASE2 |
| NCT02288208 | TERMINATED | Hepatitis B |
TetraLogic Pharmaceuticals |
2014-11 | PHASE1 |
| NCT01341106 | TERMINATED | Hepatitis B, Chronic; Liver Fibrosis |
RWTH Aachen University |
2011-04 | PHASE4 |
| NCT01595685 | COMPLETED | Chronic Viral Hepatitis B Without Delta-agent |
Asan Medical Center |
2012-05 | PHASE3 |
| NCT01833611 | UNKNOWN | Chronic Hepatitis |
National Cheng-Kung University Hospital |
2008-09 | PHASE4 |
| NCT01179594 | WITHDRAWN | Hepatitis B, Chronic |
Hoffmann-La Roche |
2010-09-18 | PHASE4 |
| NCT02881008 | COMPLETED | Chronic Hepatitis B |
Hepatera Ltd. |
2012-11-14 | PHASE1; PHASE2 |
| NCT00922207 | COMPLETED | Hepatitis B, Chronic |
Hoffmann-La Roche |
2010-05-07 | PHASE4 |
| NCT00823550 | UNKNOWN | Hepatitis B, Chronic |
Yonsei University |
2009-01 | PHASE4 |
| NCT01341743 | UNKNOWN | Hepatitis B |
Nanfang Hospital, Southern Medical University |
2010-12 | PHASE4 |
| NCT01046799 | COMPLETED | Liver Transplantation; Hepatitis B; Liver Disease |
HepNet Study House, German Liverfoundation |
2008-03 | PHASE3 |
| NCT01724723 | UNKNOWN | Hepatitis; Tuberculosis; hepatitisB |
National Taiwan University Hospital |
2012-12 | PHASE4 |
| NCT01599130 | UNKNOWN | Hepatitis B |
Sun Yat-sen University |
2012-07 | |
| NCT01594905 | UNKNOWN | Chronic Hepatitis B |
Yonsei University |
2012-08 | PHASE4 |
| NCT01926288 | COMPLETED | Chronic Hepatitis B |
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
2008-10 | PHASE4 |
| NCT00597259 | UNKNOWN | Chronic Hepatitis B |
National Taiwan University Hospital |
2008-01 | PHASE4 |
| NCT01326546 | COMPLETED | Chronic Hepatitis B |
Chongqing Jiachen Biotechnology Ltd. |
2010-06 | PHASE2 |
| NCT01204762 | COMPLETED | Hepatitis B Virus |
Bristol-Myers Squibb |
2010-11 | PHASE2 |
| NCT00921180 | UNKNOWN | Hepatitis B, Chronic |
National Taiwan University Hospital |
2007-02 | PHASE4 |
| NCT01588912 | UNKNOWN | Chronic Hepatitis B |
Pusan National University Yangsan Hospital |
2012-04 | PHASE4 |
| NCT00917761 | UNKNOWN | Hepatitis B, Chronic |
National Taiwan University Hospital |
2007-02 | PHASE4 |
| NCT01354652 | TERMINATED | Lactic Acidosis |
Asan Medical Center |
2011-05 | PHASE4 |
| NCT00423891 | COMPLETED | Hepatitis B, Chronic |
Bristol-Myers Squibb |
2007-06-30 | PHASE1; PHASE2 |
| NCT01266005 | TERMINATED | Chronic Hepatitis B |
Bukwang Pharmaceutical |
2009-08 | PHASE4 |
| NCT00877760 | COMPLETED | Chronic Hepatitis B |
Foundation for Liver Research |
2009-08 | PHASE4 |
| NCT01813487 | COMPLETED | Chronic Hepatitis B |
Genexine, Inc. |
2013-02 | |
| NCT01220596 | UNKNOWN | Hepatitis B, Chronic |
Hanyang University |
2010-06 | PHASE3 |
| NCT01243281 | UNKNOWN | Chronic Hepatitis B |
Chulalongkorn University |
2011-03 | |
| NCT01079806 | COMPLETED | Chronic Hepatitis B Virus, Pediatric |
Bristol-Myers Squibb |
2010-06-30 | PHASE3 |
| NCT01589952 | UNKNOWN | Chronic Hepatitis B |
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
2012-03 | PHASE1; PHASE2 |
| NCT01139203 | UNKNOWN | Liver Transplantation; Hepatitis B |
Shanghai Jiao Tong University School of Medicine |
2009-08 | |
| NCT00986778 | WITHDRAWN | Hepatitis B, Chronic |
Bristol-Myers Squibb |
2009-12 | PHASE4 |
| NCT01641536 | COMPLETED | Hepatitis B, Chronic |
Genexine, Inc. |
2011-11 | PHASE1 |
| NCT00926757 | COMPLETED | Non Hodgkin's Lymphoma; Hepatitis B |
Taipei Veterans General Hospital, Taiwan |
2009-04 | PHASE4 |
| NCT01027065 | UNKNOWN | Chronic Hepatitis B |
Cytheris SA |
2009-12 | PHASE1; PHASE2 |
| NCT01063036 | COMPLETED | Chronic Hepatitis B |
Bristol-Myers Squibb |
2010-05 | PHASE3 |
| NCT01892241 | COMPLETED | Antiviral Treatment of Chronic Hepatitis B |
Third Affiliated Hospital, Sun Yat-Sen University |
2010-01 | PHASE3 |
| NCT01242787 | UNKNOWN | Chronic Hepatitis B |
LG Life Sciences |
2010-08 | PHASE2 |
| NCT01023217 | COMPLETED | Hepatitis B, Chronic |
Asan Medical Center |
2009-11 | PHASE4 |
| NCT01083251 | UNKNOWN | Hepatitis B Virus |
Ziv Hospital |
2010-03 | |
| NCT01546116 | COMPLETED | Chronic Hepatitis B |
Korea University |
2010-02 | PHASE4 |
| NCT00940485 | COMPLETED | Hepatitis B, Chronic |
Hoffmann-La Roche |
2009-04 | PHASE4 |
| NCT01148576 | UNKNOWN | Chronic Hepatitis B; Hepatic Steatosis |
Zhejiang University |
2010-06 | PHASE4 |
| NCT00994773 | COMPLETED | Hepatitis B |
Bader, Ted, M.D. |
2009-12 | PHASE1 |
| NCT01023230 | COMPLETED | Hepatitis B, Chronic |
Dynavax Technologies Corporation |
2009-09 | PHASE1 |
| NCT00531167 | COMPLETED | Chronic Hepatitis B |
Korea University |
2007-04 | PHASE4 |
| NCT00298363 | COMPLETED | Chronic Hepatitis B |
Gilead Sciences |
2006-04 | PHASE2 |
| NCT00371150 | COMPLETED | Hepatitis B Infection |
Bristol-Myers Squibb |
2006-11 | PHASE4 |
| NCT00395018 | COMPLETED | Hepatitis B, Chronic |
Bristol-Myers Squibb |
2007-04 | PHASE3 |
| NCT00410202 | COMPLETED | Hepatitis B, Chronic |
Bristol-Myers Squibb |
2008-03 | PHASE3 |
| NCT00663182 | UNKNOWN | Hepatitis B Virus; Decompensated Cirrhosis |
Shanghai Changzheng Hospital |
2008-01 | PHASE4 |
| NCT00625339 | COMPLETED | Hepatitis B, Chronic |
Yonsei University |
2008-02 | PHASE4 |
| NCT01026610 | COMPLETED | Chronic Hepatitis B |
LG Life Sciences |
2009-08 | PHASE2 |
| NCT00824707 | COMPLETED | Primary Liver Cancer |
Eastern Hepatobiliary Surgery Hospital |
2008-12 | |
| NCT00637663 | COMPLETED | Hepatitis B, Chronic |
Pusan National University Hospital |
2008-02 | PHASE4 |
| NCT00410072 | COMPLETED | Hepatitis B, Chronic |
Bristol-Myers Squibb |
2007-04 | PHASE3 |
| NCT01013272 | COMPLETED | Hepatitis B, Chronic |
The University of Hong Kong |
2007-06 | |
| NCT00662545 | COMPLETED | HIV Infections; Hepatitis B |
University of California, San Francisco |
2008-04 | PHASE4 |
| NCT00555334 | UNKNOWN | Hepatocellular Carcinoma; Liver Cancer |
Sun Yat-sen University |
2007-11 | PHASE4 |
| NCT01438424 | COMPLETED | Hepatitis B Virus; HBV |
Bristol-Myers Squibb |
2001-01 | PHASE2 |
| NCT00718887 | COMPLETED | Hepatitis B, Chronic |
Bristol-Myers Squibb |
2008-07 | PHASE4 |
| NCT00625560 | COMPLETED | Hepatitis B, Chronic |
Yonsei University |
2008-02 | PHASE4 |
| NCT00614471 | COMPLETED | Hepatitis B, Chronic |
Hoffmann-La Roche |
2007-08 | PHASE4 |
| NCT00467545 | COMPLETED | Chronic Hepatitis B |
Novartis Pharmaceuticals |
2007-04 | PHASE4 |
| NCT00768157 | UNKNOWN | Hepatocellular Carcinoma; Hepatitis B Virus; Recurrence |
Sun Yat-sen University |
2007-04 | PHASE4 |
| NCT01254994 | COMPLETED | Liver Failure |
Sun Yat-sen University |
2007-08 | PHASE2 |
| NCT00605384 | TERMINATED | Chronic Hepatitis B |
Bristol-Myers Squibb |
2008-08 | PHASE3 |
| NCT00393484 | COMPLETED | Chronic Hepatitis B |
Bristol-Myers Squibb |
2007-02 | PHASE4 |
| NCT00065507 | COMPLETED | Hepatitis B |
Bristol-Myers Squibb |
2003-08 | PHASE3 |
| NCT01018381 | COMPLETED | Hepatocellular Carcinoma; Hepatitis B |
The 108 Military Central Hospital |
2006-06 | |
| NCT00412529 | COMPLETED | Hepatitis B; Chronic Hepatitis B |
Novartis Pharmaceuticals |
2006-12 | PHASE3 |
| NCT00975091 | COMPLETED | Chronic Hepatitis B Virus |
Bristol-Myers Squibb |
2004-05 | PHASE3 |
| NCT01037062 | COMPLETED | Chronic Hepatitis B |
Bristol-Myers Squibb |
2003-12 | PHASE2 |
| NCT00096785 | COMPLETED | Hepatitis B; Chronic Disease |
Bristol-Myers Squibb |
2004-12 | PHASE3 |
| NCT00051038 | COMPLETED | Hepatitis B |
Bristol-Myers Squibb |
2002-09 | PHASE2; PHASE3 |
| NCT00035789 | COMPLETED | Chronic Hepatitis B |
Bristol-Myers Squibb |
2001-11 | PHASE3 |
| NCT01022801 | COMPLETED | Chronic Hepatitis B |
Bristol-Myers Squibb |
2003-08 | PHASE2 |
| NCT00036608 | COMPLETED | Chronic Hepatitis B |
Bristol-Myers Squibb |
2002-01 | PHASE3 |
| NCT01037166 | COMPLETED | Chronic Hepatitis B |
Bristol-Myers Squibb |
2002-12 | PHASE2 |
| NCT01020565 | COMPLETED | Chronic Hepatitis B |
Bristol-Myers Squibb |
2003-02 | PHASE2 |
| NCT00035633 | COMPLETED | Chronic Hepatitis B |
Bristol-Myers Squibb |
2001-12 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-01-16)
Check the
Entecavir
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.