A study to understand the safety and effectiveness of a new drug called TAF compared to an existing treatment called Viread for the treatment of long term hepatitis B infection.

Phase 1

• Conditions: Chronic Hepatitis B; MedDRA version: 16.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-000636-10-ES
• Lead Sponsor: Gilead Sciences Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-10
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1056

Inclusion Criteria

1) Must have the ability to understand and sign a written informed consent form.

2) Adult male and non-pregnant, non-lactating female subjects, 18 years of age and older. A negative serum pregnancy test at Screening is required for female subjects of childbearing potential (unless surgically sterile or greater than two years post-menopausal).

3) Documented evidence of chronic HBV infection.

4) HBeAg positive, chronic hepatitis B.

5) Treatment naïve subjects or treatment experienced subjects will be eligible for enrollment. Treatment experienced subjects receiving oral antiviral treatment at Screening must continue their treatment regimen until the time of randomization, when it will be discontinued.

6) Any previous treatment with interferon (pegylated or non-pegylated) must have ended at least 6 months prior to the baseline visit.

7) Estimated creatinine clearance (CLCr) > or = 60 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the Screening evaluation.

8) Normal ECG.

9) Willing and able to comply with all study requirements.
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 834
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1) Pregnant women, women who are breastfeeding 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, protocol specified method(s) of contraception during the study.

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

4) Evidence of hepatocellular carcinoma.

5) Any history of, or current evidence of, clinical hepatic decompensation.

6) Abnormal hematological and biochemical parameters.

7) Received solid organ or bone marrow transplant.

8) Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the investigator.

9) Significant bone disease (eg, osteomalacia, chronic osteomyelitis, osteogenesis
imperfecta, osteochrondroses), or multiple bone fractures.

Study & Design

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