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Study to Compare Tenofovir Al...

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

NCT ID: NCT01940341

Last Updated: 2023-09-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

426 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-12

Study Completion Date

2022-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HBeAg-negative Chronic Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TAF 25 mg

TAF + TDF placebo for 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).

Group Type EXPERIMENTAL

TAF

Intervention Type DRUG

25 mg tablet administered orally once daily

TDF Placebo

Intervention Type DRUG

Tablet administered orally once daily

TDF 300 mg

TDF + TAF placebo for 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).

Group Type ACTIVE_COMPARATOR

TDF

Intervention Type DRUG

300 mg tablet administered orally once daily

TAF Placebo

Intervention Type DRUG

Tablet administered orally once daily

Open-label TAF

All participants who complete the double-blind period (96 weeks or 144 weeks) will be eligible to receive open-label TAF until Week 384 of the study.

After the end of study treatment, participants can either switch to commercially available anti-HBV treatments in their country or will be followed every 4 weeks, for up to 24 weeks off treatment (treatment-free follow-up (TFFU)) for safety assessment.

Group Type EXPERIMENTAL

TAF

Intervention Type DRUG

25 mg tablet administered orally once daily

Interventions

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TAF

25 mg tablet administered orally once daily

Intervention Type DRUG

TDF

300 mg tablet administered orally once daily

Intervention Type DRUG

TAF Placebo

Tablet administered orally once daily

Intervention Type DRUG

TDF Placebo

Tablet administered orally once daily

Intervention Type DRUG

Other Intervention Names

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Vemlidy® GS-7340 Viread®

Eligibility Criteria

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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.
* Normal electrocardiogram (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, 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.
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Asian Pacific Liver Center

Los Angeles, California, United States

Site Status

Stanford University Medical Center

Palo Alto, California, United States

Site Status

Huntington Medical Research Institutes

Pasadena, California, United States

Site Status

Research and Education, Inc.

San Diego, California, United States

Site Status

University California San Francisco (UCSF)

San Francisco, California, United States

Site Status

Silicon Valley Research Institute

San Jose, California, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Digestive Disease Associates, PA

Catonsville, Maryland, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

ID Care

Hillsborough, New Jersey, United States

Site Status

Sing Chan Private Practice

Flushing, New York, United States

Site Status

New Discovery, LLC

Flushing, New York, United States

Site Status

Xiaoli Ma, PC

Philadelphia, Pennsylvania, United States

Site Status

Hunter Holmes McGuire VA DVMC

Richmond, Virginia, United States

Site Status

Monash Medical Centre

Clayton, Victoria, Australia

Site Status

St. Vincent's Hospital

Fitzroy, Victoria, Australia

Site Status

Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Site Status

Royal Perth Hospital

Perth, Western Australia, Australia

Site Status

University of Calgary

Calgary, Alberta, Canada

Site Status