This trial is active, not recruiting.

Conditions hbv, chronic hbv infections
Treatments taf, tdf, taf placebo, tdf placebo
Phase phase 3
Sponsor Gilead Sciences
Start date June 2015
End date December 2016
Trial size 181 participants
Trial identifier NCT02836249, 2013-000636-10, GS-US-320-0110 (China)


The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B virus (HBV) infection in China.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
TAF + TDF placebo for 144 weeks
taf GS-7340
TAF 25 mg tablet administered orally once daily
tdf placebo
TDF placebo tablet administered orally once daily
(Active Comparator)
TDF + TAF placebo for 144 weeks
tdf Viread®
TDF 300 mg tablet administered orally once daily
taf placebo
TAF placebo tablet administered orally once daily
All participants who complete the double-blind period will be eligible to receive open-label TAF until Week 384 of the study.
taf GS-7340
TAF 25 mg tablet administered orally once daily

Primary Outcomes

Proportion of participants with hepatitis B virus (HBV) DNA < 29 IU/mL
time frame: Week 48

Secondary Outcomes

Proportion of participants with hepatitis B e antigen (HBeAg) loss with seroconversion to antibody against HBeAb (anti-HBe) at Week 48
time frame: Week 48
Percent change from baseline in hip bone mineral density (BMD) at Week 48
time frame: Baseline; Week 48
Percent change from baseline in spine BMD at Week 48
time frame: Baseline; Week 48
Change from baseline at Week 48 in serum creatinine
time frame: Baseline; Week 48

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures - Adult males and non-pregnant, non-lactating females - Documented evidence of chronic HBV infection - HBeAg-positive, chronic hepatitis B with all of the following: - HBeAg-positive at screening - Screening HBV DNA ≥ 2 x 10^4 IU/mL - Screening serum alanine aminotransferase (ALT) level > 60 U/L (males) or > 38 U/L (females) and ≤ 10 x the upper limit of the normal range (ULN) - Treatment-naive participants (defined as < 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue) OR treatment-experienced participants (defined as participants meeting all entry criteria [including HBV DNA and serum ALT criteria] and with ≥ 12 weeks of previous treatment with any nucleoside or nucleotide analogue) - Previous treatment with interferon (pegylated or non-pegylated) must have ended at least 6 months prior to the baseline visit - Adequate renal function - Normal ECG Exclusion Criteria: - Females who are breastfeeding - Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study - Co-infection with hepatitis C virus, HIV, or hepatitis D virus - Evidence of hepatocellular carcinoma - Any history of, or current evidence of, clinical hepatic decompensation - Abnormal hematological and biochemical parameters, including aspartate aminotransferase (AST) > 10 x ULN - Received solid organ or bone marrow transplant - History of malignancy within the past 5 years, with the exception of specific cancers that are cured by surgical resection; individuals under evaluation for possible malignancy are not eligible - Currently receiving therapy with immunomodulators (eg, corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion - Individuals receiving ongoing therapy with drugs not to be used with tenofovir alafenamide or tenofovir disoproxil fumarate or individuals with a known hypersensitivity to study drugs, metabolites, or formulation excipients - Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance - Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements

Additional Information

Official title A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg Positive, Chronic Hepatitis B
Description This study GS-US-320-0110 is an international study planned to enroll participants in global countries, including China. However, due to the review timeline difference in China, full enrollment was reached in the main study (NCT01940471) before China was able to participate. Therefore, this registration only includes the China cohorts as they will not be part of the main study analysis. Data for China cohorts will be analyzed separately at a later time.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.