At a glance
ClinicalIndex Comparison Record- ✓Age 18–69 years
- ✓Chronic HBV infection: positive serum HBsAg for at least 6 months
- ✓Currently on adefovir dipivoxil 10 mg once daily for 24–96 weeks
- ✓HBV DNA ≥1000 copies/mL at screening
- ✕Decompensated liver disease: conjugated bilirubin >1.5× ULN, PT >1.5× ULN, platelets <75,000/mm³, albumin <3.0 g/dL, or prior hepatic decompensation
- ✕Prior use of tenofovir DF or entecavir
- ✕Interferon or pegylated interferon within 6 months of screening
- ✕Evidence of hepatocellular carcinoma (HCC): alpha-fetoprotein >50 ng/mL or other standard of care measure
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double-Blind Study Exploring the Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus Emtricitabine Plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects Currently Being Treated With Adefovir Dipivoxil for Chronic Hepatitis B and Having Persistent Viral Replication
In Brief
A Phase 2 clinical trial evaluating tenofovir DF and emtricitabine /tenofovir DF for Chronic Hepatitis B. Completed, enrolled 106 participants across 28 sites in 4 countries.
Detailed Summary
This study explores the efficacy, safety and tolerability of tenofovir DF (TDF) 300 mg once daily monotherapy versus the combination of emtricitabine 200 mg plus tenofovir DF 300 mg (FTC/TDF) once daily in subjects currently being treated with adefovir dipivoxil (Hepsera) for chronic hepatitis B who have persistent viral replication (detectable hepatitis B virus deoxyribonucleic acid \[HBV DNA\]). Subjects with confirmed (within 4 weeks) plasma HBV DNA ≥ 400 copies/mL during double blind treatment at Week 24 or any time thereafter have the option of receiving 12 weeks of open-label FTC/TDF which may be continued through the end of the 168-week treatment period if there is a virologic response (HBV DNA \< 400 copies/mL). Alternatively, subjects with confirmed HBV DNA \< 400 copies/mL at or any time after Week 24 of double-blind treatment may continue blinded therapy up to Week 168 at the discretion of the investigator. If, in the investigator's opinion, it is felt that continued blinded treatment beyond 24 weeks in subjects with confirmed HBV DNA ≥ 400 copies/mL is not beneficial, the subject may discontinue the study and begin commercially available HBV therapy rather than initiate open-label FTC/TDF.
Study Details
Timeline
Interventions
300 mg tablet, once daily (QD)
emtricitabine 200 mg/tenofovir DF 300 mg once daily (combination tablet)