Clinical Trials
Numerous clinical trials spanning early to late phases have evaluated adefovir dipivoxil for chronic hepatitis B, liver fibrosis, cirrhosis, and concurrent HIV infections. Sponsored by industry leaders including Gilead Sciences and GlaxoSmithKline alongside government institutions like the National Institute of Diabetes and Digestive and Kidney Diseases, these active, completed, and terminated protocols examined combination antiviral regimens and pharmacokinetic interactions. Ultimately, this body of research led to widespread regulatory marketing approval.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT00973219 | COMPLETED | Chronic Hepatitis B |
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
2009-09 | |
| NCT02965859 | UNKNOWN | Chronic Hepatitis B |
Guangzhou Yipinhong Pharmaceutical CO.,LTD |
2012-12 | PHASE2 |
| NCT02327416 | UNKNOWN | Hepatitis B, Chronic |
Tongji Hospital |
2014-10 | PHASE3 |
| NCT00810524 | UNKNOWN | Hepatitis B, Chronic |
Sun Yat-sen University |
2007-01 | PHASE4 |
| NCT02826070 | UNKNOWN | Hepatitis B, Chronic |
Nanfang Hospital, Southern Medical University |
2015-04 | PHASE4 |
| NCT02327689 | UNKNOWN | Hepatitis B, Chronic; Fibrosis |
Asian-Pacific Alliance of Liver Disease, Beijing |
2015-01 | PHASE4 |
| NCT01521975 | COMPLETED | Hepatitis B, Chronic |
Third Affiliated Hospital, Sun Yat-Sen University |
2011-01-01 | PHASE4 |
| NCT01436539 | UNKNOWN | Chronic Hepatitis B |
Jun Cheng |
2011-09 | PHASE4 |
| NCT00672867 | COMPLETED | Patients With LC-B |
Bukwang Pharmaceutical |
2007-12 | PHASE3 |
| NCT01300234 | COMPLETED | Hepatitis B |
GlaxoSmithKline |
2011-03-30 | PHASE3 |
| NCT01264354 | COMPLETED | Chronic Hepatitis B |
Bukwang Pharmaceutical |
2010-03 | PHASE4 |
| NCT01581242 | COMPLETED | Healthy |
Bukwang Pharmaceutical |
2012-04 | PHASE1 |
| NCT00641082 | COMPLETED | HBeAg(-) Chronic Hepatitis B With Compensated Liver Function |
Bukwang Pharmaceutical |
2008-02 | PHASE4 |
| NCT01146808 | COMPLETED | Hepatitis B; Liver Transplantation |
Columbia University |
2006-03 | PHASE1; PHASE2 |
| NCT00661076 | COMPLETED | Hepatitis B, Chronic |
Hoffmann-La Roche |
2008-08 | PHASE3 |
| NCT01353742 | COMPLETED | Hepatitis B, Chronic |
GlaxoSmithKline |
2011-02-21 | PHASE1 |
| NCT00531167 | COMPLETED | Chronic Hepatitis B |
Korea University |
2007-04 | PHASE4 |
| NCT00715715 | WITHDRAWN | Chronic Hepatitis B |
Maimonides Medical Center |
2008-04 | |
| NCT00023309 | COMPLETED | HBV (Hepatitis B Virus); Hepatitis B; Hepatitis |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2001-08 | PHASE2 |
| NCT00606099 | WITHDRAWN | Chronic Hepatitis B |
Novartis |
2007-11 | PHASE4 |
| NCT00347009 | COMPLETED | Hepatitis B, Chronic; Cirrhosis; Fibrosis; Chronic Hepatitis B |
GlaxoSmithKline |
2005-05 | PHASE4 |
| NCT00753467 | UNKNOWN | Hepatitis B |
Huntington Medical Research Institutes |
2008-09 | PHASE2 |
| NCT02598063 | COMPLETED | Hepatitis B, Chronic |
Hoffmann-La Roche |
2005-10 | PHASE4 |
| NCT00307242 | COMPLETED | Chronic Hepatitis B |
Thomas Jefferson University |
2005-06-17 | PHASE4 |
| NCT00371761 | COMPLETED | Hepatitis B, Chronic (CHB) |
Merck Sharp & Dohme LLC |
2006-09 | PHASE3 |
| NCT00324961 | COMPLETED | Chronic Hepatitis B |
GlaxoSmithKline |
2006-01 | PHASE4 |
| NCT00441974 | COMPLETED | Chronic Hepatitis B |
GlaxoSmithKline |
2006-12 | PHASE4 |
| NCT00376259 | TERMINATED | Hepatitis B |
Novartis |
2007-01 | PHASE3 |
| NCT00187746 | WITHDRAWN | Other Conditions That May Be A Focus of Clinical Attention |
University of California, San Francisco |
2005-08 | PHASE4 |
| NCT00403585 | COMPLETED | Hepatitis B, Chronic; Chronic Hepatitis B |
GlaxoSmithKline |
2006-07 | PHASE4 |
| NCT00857675 | COMPLETED | Chronic Hepatitis B |
GlaxoSmithKline |
2002-12 | PHASE3 |
| NCT00316719 | COMPLETED | Chronic Hepatitis B |
GlaxoSmithKline |
2006-01 | PHASE3 |
| NCT00307489 | COMPLETED | Chronic Hepatitis B |
Gilead Sciences |
2006-03 | PHASE2 |
| NCT00116805 | COMPLETED | Chronic Hepatitis B |
Gilead Sciences |
2005-06 | PHASE3 |
| NCT00117676 | COMPLETED | Chronic Hepatitis B |
Gilead Sciences |
2005-02 | PHASE3 |
| NCT00115245 | COMPLETED | Chronic Hepatitis B |
Novartis |
2004-11 | PHASE3 |
| NCT00095121 | COMPLETED | Chronic Hepatitis B |
Gilead Sciences |
2004-06 | PHASE3 |
| NCT01205165 | COMPLETED | Hepatitis B, Chronic |
GlaxoSmithKline |
2004-12-17 | PHASE4 |
| NCT00071201 | COMPLETED | Chronic Hepatitis B |
Gilead Sciences |
2003-06 | PHASE3 |
| NCT00489151 | Unknown status | Hepatitis B |
Hospital Authority Hong Kong|The University of Hong Kong |
2005-06 | Not Applicable |
| NCT00644761 | COMPLETED | Hepatitis B |
Gilead Sciences |
2004-02 | PHASE2 |
| NCT00644761 | Completed | Hepatitis B |
Gilead Sciences |
2004-02 | Phase 2 |
| NCT00645294 | COMPLETED | Hepatitis B |
Gilead Sciences |
2003-02 | PHASE1; PHASE2 |
| NCT00230477 | Completed | Hepatitis B |
University of Washington|Gilead Sciences|GlaxoSmithKline |
2003-04 | Phase 4 |
| NCT00158717 | Completed | Hepatitis B |
Gilead Sciences |
2003-04 | -- |
| NCT00001082 | COMPLETED | Cytomegalovirus Infections; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
1996-12 | PHASE3 |
| NCT00489151 | UNKNOWN | Hepatitis B |
Hospital Authority, Hong Kong |
2005-06 | |
| NCT00002184 | COMPLETED | HIV Infections |
Gilead Sciences |
PHASE2 | |
| NCT00000843 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE1 | |
| NCT00002346 | COMPLETED | HIV Infections |
Gilead Sciences |
PHASE1 | |
| NCT00002161 | COMPLETED | HIV Infections |
Gilead Sciences |
||
| NCT00002426 | COMPLETED | HIV Infections |
Gilead Sciences |
||
| NCT00000912 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00001087 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00002379 | COMPLETED | HIV Infections |
Gilead Sciences |
PHASE2 | |
| NCT00002219 | UNKNOWN | HIV Infections |
Gilead Sciences |
PHASE2 | |
| NCT00000885 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00051077 | WITHDRAWN | HIV Infections; Hepatitis B; Hepatitis C |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00158704 | TERMINATED | Hepatitis B |
Gilead Sciences |
2002-01 | |
| NCT00023153 | COMPLETED | HIV Infections; Chronic Hepatitis B |
National Institute of Allergy and Infectious Diseases (NIAID) |
2001-08 | PHASE3 |
| NCT00000892 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
||
| NCT00033163 | COMPLETED | HIV Infections; Hepatitis B |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00002128 | COMPLETED | HIV Infections |
Gilead Sciences |
PHASE1 | |
| NCT00002206 | COMPLETED | HIV Infections |
Gilead Sciences |
PHASE1 | |
| NCT00013702 | COMPLETED | Hepatitis B; HIV Infection |
National Institute of Allergy and Infectious Diseases (NIAID) |
2001-03 | PHASE2 |
| NCT00230477 | COMPLETED | Hepatitis B |
University of Washington |
2003-04 | PHASE4 |
| NCT00002398 | COMPLETED | HIV Infections |
Gilead Sciences |
||
| NCT00002220 | COMPLETED | HIV Infections |
Merck Sharp & Dohme LLC |
PHASE3 | |
| NCT00002234 | COMPLETED | HIV Infections |
Gilead Sciences |
PHASE2 | |
| NCT00002419 | COMPLETED | HIV Infections |
Gilead Sciences |
PHASE2 |
(data from https://clinicaltrials.gov, updated on 2021-03-29)
Check the
Adefovir Dipivoxil (GS 0840)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Compliance for Clinical Use
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>).
Jump to
- Adefovir Dipivoxil (GS 0840) Solubility in DMSO
- Adefovir Dipivoxil (GS 0840) Stock Solution
- Adefovir Dipivoxil (GS 0840) Storage
- Adefovir Dipivoxil (GS 0840) Stability
- Adefovir Dipivoxil (GS 0840) Molecular Weight
- Adefovir Dipivoxil (GS 0840) SMILES
- Adefovir Dipivoxil (GS 0840) CAS Number
- Adefovir Dipivoxil (GS 0840) Chemical Structure (2D and 3D)
- Adefovir Dipivoxil (GS 0840) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.