Status:
COMPLETED
A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Negative Chronic Hepatitis B
Lead Sponsor:
Gilead Sciences
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-69 years
Phase:
PHASE3
Brief Summary
This primary objectives of this study are to compare the efficacy, safety, and tolerability of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of pre-core mutant ...
Eligibility Criteria
Inclusion
- Key
- Chronic hepatitis B virus (HBV) infection, defined as positive serum hepatitis B s-antigen (HBsAg) for at least 6 months.
- 18 through 69 years of age, inclusive.
- Active hepatitis B e-antigen (HBeAg) negative chronic HBV infection, with all of the following:
- HBeAg negative and HBeAb positive at screening
- Alanine aminotransferase (ALT) levels \> the upper limit of the normal range (ULN) and ≤ 10 x ULN
- Serum HBV DNA \> 100,000 copies/mL at screening
- Creatinine clearance ≥ 70 mL/min
- Hemoglobin ≥ 8 g/dL
- Neutrophils ≥ 1,000 /mL
- Knodell necroinflammatory score ≥ 3 and a Knodell fibrosis score \< 4; however, up to 120 patients with cirrhosis, ie, a Knodell fibrosis score equal to 4, will be eligible for enrollment
- Negative serum β-human chorionic gonadotropin (hCG)
- Nucleotide naive, ie, no prior nucleotide (TDF or ADV) therapy for greater than 12 weeks
- Nucleoside naive, ie, no prior nucleoside (any nucleoside) therapy for greater than 12 weeks. However, up to 120 patients with \> 12 weeks prior lamivudine experience will be eligible
- Willing and able to provide written informed consent
- Had a liver biopsy performed within 6 months of baseline and has readable biopsy slides or agrees to have a biopsy performed prior to baseline
- Key
Exclusion
- Pregnant women, women who are breast feeding, or women who believe they may wish to become pregnant during the course of the study
- Males and females of reproductive potential who are unwilling to use an effective method of contraception during the study.
- Decompensated liver disease defined as conjugated bilirubin \> 1.5 x ULN, prothrombin time (PT) \> 1.5 x ULN, platelets \< 75,000/mL, serum albumin \< 3.0 g/dL, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)
- Received any nucleoside, nucleotide (TDF or ADV) or interferon (pegylated or not) therapy within 6 months prior to the pre treatment biopsy
- Evidence of hepatocellular carcinoma (HCC)
- Coinfection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus (HDV)
- Significant renal, cardiovascular, pulmonary, or neurological disease
- Received solid organ or bone marrow transplantation
- Is currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion
- Has proximal tubulopathy
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
382 Patients enrolled
Trial Details
Trial ID
NCT00117676
Start Date
February 1 2005
End Date
January 1 2016
Last Update
March 7 2017
Active Locations (80)
Enter a location and click search to find clinical trials sorted by distance.
1
La Jolla, California, United States, 92037
2
Pasadena, California, United States, 91105
3
San Diego, California, United States, 92105
4
San Diego, California, United States, 92123