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Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Negative for Hepatitis B e Antigen | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Negative for Hepatitis B e Antigen

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

NCT01940341•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.

Detailed Description

Study GS-US-320-0108 is a multi-center clinical trial, planned to enroll participants in multiple countries, including China. However, due to the review timeline difference in China, full enrollment was reached in the main study before China was able to participate. Therefore, details for the China cohort was registered separately (NCT02836236) on ClinicalTrials.gov as the China cohort will not be part of the main study analysis.

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 Baseline.
•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, human immunodeficiency 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 (105)

Asian Pacific Liver Center

Los Angeles, California, United States

Stanford University Medical Center

Palo Alto, California, United States

Huntington Medical Research Institutes

Pasadena, California, United States

Research and Education, Inc.

San Diego, California, United States

University California San Francisco (UCSF)

San Francisco, California, United States

Silicon Valley Research Institute

San Jose, California, United States

University of Miami

Miami, Florida, United States

Digestive Disease Associates, PA

Catonsville, Maryland, United States

Henry Ford Health System

Detroit, Michigan, United States

ID Care

Hillsborough, New Jersey, United States

Key Dates

Start Date

September 12, 2013

Primary Completion Date

September 30, 2015

Completion Date

August 31, 2022

Last Updated

September 25, 2023

Enrollment

426

ACTUAL participants

Conditions

HBeAg-negative Chronic Hepatitis B

Interventions

TAF

DRUG

TDF

DRUG

TAF Placebo

DRUG

TDF Placebo

DRUG