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Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B (China) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B (China)

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-Negative, Chronic Hepatitis B

NCT02836236•Gilead Sciences

View on ClinicalTrials.gov

Summary

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)-negative chronic hepatitis B virus (HBV) infection in China.

Detailed Description

This study GS-US-320-0108 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 (NCT01940341) before China was able to participate. Therefore, this registration only includes the China cohorts as they were not part of the main study analysis. Data for China cohorts were analyzed separately after the main study analysis was completed.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
•Hepatitis e antigen (HBeAg)-negative, chronic hepatitis B with all of the following:
•* HBeAg-negative and hepatitis B e antibody (HBeAb) 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
+1 more criteria

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
•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
+1 more criteria

Locations (29)

Peking University First Hospital

Beijing, Beijing Municipality, China

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

The 1st Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi Zhuang, China

The Affiliated Hospital of Guiyang Medical College

Guiyang, Guiyang, China

The 3rd Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Tongji Hospital, Tongji Medical college HuaZhong University of Science&Technology

Wuhan, Hubei, China

Nanjing No. 2 Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

The sixth People's Hospital of Shenyang

Shenyang, Liaoning, China

Key Dates

Start Date

June 19, 2015

Primary Completion Date

April 5, 2017

Completion Date

September 18, 2023

Last Updated

October 2, 2024

Enrollment

155

ACTUAL participants

Conditions

HBVChronic HBV Infection

Interventions

TAF

DRUG

TDF

DRUG

TAF Placebo

DRUG

TDF Placebo

DRUG

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Chronic Hep BChronic Hepatitis b+2 more

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B (China)

Inclusion Criteria

Exclusion Criteria

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

Single Cell Landscape of HBV-related Acute-on-chronic Liver Failure Patients

Study on the Treatment of Hepatitis B Virus(HBV) Infected Individuals With Peginterferon α-2b Combined With NA.

The TRIple Elimination Model Of Mother-to-child Transmission Program (TRI-MOM)

MAGIA H3S Point of Care Test Performance for HIV, HBV, HCV, and Syphilis Screening in Pregnant Women in DR Congo