A randomized, double blind, controlled evaluation of Tenofovir DF versus Adefovir Dipivoxil for the treatment of presumed pre-core mutant chronic hepatitis B.

Phase 1

• Conditions: Treatment of chronic hepatitis B; MedDRA version: 14.1Level: PTClassification code 10019731Term: Hepatitis BSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2004-005119-27-IT
• Lead Sponsor: Gilead Sciences Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-08
• Study Completion: 2016-01-19
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 382

Inclusion Criteria

-Chronic HBV infection, defined as positive serum HBsAg for at least 6 months; -18 through 69 years of age, inclusive; -Active HBeAg negative chronic HBV infection, with all of the following: -HBeAg negative and HBeAb positive at screening; -ALT level >ULN and =10xULN; -Serum HBV DNA >100000 copies/ml at screening; _creatinine clearance =70 ml/min; -hemoglobin =8 g/dl; -neutrophilis =1000 /mm3; -Nucleotide naive, i.e., no prior nucleotide (tenofovir DF or adefovir dipivoxil) therapy for greater than 12 weeks; -NUcleoside naive, i.e., no prior nucleoside (any nucleoside) therapy for greater than 12 weeks. However, up to 120 patinets with greater than 12 weeks prior lamivudine or emtricitabine experienced prior to eligible.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 285
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

-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 > 1.5xULN, PT >1.5ULN, platelets < 75.000/mm3, serum albumin <3.0 g/dl, or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalophaty, variceal hemorrhage); -Received any nucleoside, nucleotide (tenofovir DF or adefovir dipivoxil) or interferon (pegylated or not) therapy within 6 months prior of the pre-treatment biopsy; -Evidence of hepatocellular carcinoma (HCC); -Co-infection with HCV, HIV or HDV; -Significant renal, cardiovascular, pulmonary, or neurological disease; -Is currently receiving therapy with immunomodulators (e.g., corticosteroids, ect.), investigationals agents, nephrotoxic agents, or agents susceptible of modifying renal excretion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified