A study in people with long-lasting hepatitis B to assess the effectiveness and safety of the two drugs Viread and Hepsera.

Phase 1

• Conditions: Chronic Hepatitis B; MedDRA version: 15.1 Level: PT Classification code 10008910 Term: Chronic hepatitis B System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2004-005120-41-GB
• Lead Sponsor: Gilead Sciences Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-04-04
• Study Completion: 2016-01-28
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 271

Inclusion Criteria

1) Chronic HBV infection, defined as positive serum HBsAg for more than 6 months.

2) 18 through 69 years of age, inclusive.

3) Active HBeAg positive chronic HBV infection, with all of the following:
• HBeAg positive at screening
• ALT levels > 2 x ULN and = 10 x ULN
• Serum HBV DNA >1000000 copies/mL at screening
• creatinine clearance = 70 mL/min
• hemoglobin = 8 g/dL
• neutrophils = 1,000 /mm3

4) Knodell necroinflammatory score = 3 and a Knodell fibrosis score < 4. However, up to 96 patients with cirrhosis, i.e., a Knodell fibrosis score equal to 4, will be eligible for enrollment.

5) Negative serum ß-HCG

6) Nucleotide naïve, i.e., no prior nucleotide (tenofovir DF or adefovir dipivoxil) therapy for greater than 12 weeks.

7) Nucleoside naïve, i.e., no prior nucleoside (any nucleoside) therapy for greater than 12 weeks.

8) Willing and able to provide written informed consent.

9) 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 228
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

1) Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study.

2) Males and females of reproductive potential who are unwilling to use an effective” method of contraception during the study. For males, condoms should be used and for females, a barrier contraception method should be used.

3) Decompensated liver disease defined as conjugated bilirubin >1.5 x ULN, PT > 1.5 x ULN, platelets < 75,000/mm3, serum albumin < 3.0 g/dL, or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy, variceal hemorrhage).

4) Received any nucleoside, nucleotide (tenofovir DF or adefovir dipivoxil) or interferon (pegylated or not) therapy within 6 months prior of the pre-treatment biopsy.

5) Evidence of hepatocellular carcinoma (HCC), for example, a fetoprotein > 50 ng/mL or by any other standard of care measure.

6) Co-infection with HCV, HIV, or HDV.

7) Significant renal, cardiovascular, pulmonary, or neurological disease.

8) Received solid organ or bone marrow transplantation.

9) Is currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion.

10) Has proximal tubulopathy.

11) Known hypersensitivity to the study drugs, the metabolites or formulation excipients.

Study & Design

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