Study Details

OVERVIEW

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

PROTOCOL 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.

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

HBV, Chronic HBV Infection

Gender

N/A

Date

June 2015 - April 2017

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

TAF, TDF, TAF Placebo, TDF Placebo

Eligibility Information

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
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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

Locations (29)

Peking University First Hospital

Beijing, Beijing, China, 100034

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China, 510630

The 1st Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China, 530021

The Affiliated Hospital of Guiyang Medical College

Guiyang, Guiyang, China, 550004

The 3rd Hospital of Hebei Medical University

Shijiazhuang, Hebei, China, 050051

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

Wuhan, Hubei, China, 430030

Nanjing No. 2 Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330006

The First Hospital of Jilin University

Changchun, Jilin, China, 130021

The sixth People's Hospital of Shenyang

Shenyang, Liaoning, China, 110006

Jinan Infectious Disease Hospital

Jinan, Shandong, China, 250021

West China Hospital, Sichuan University

Chengdu, Sichuan, China, 610041

No.1 Hospital Affiliated to Kunming Medical College

Kunming, Yunnan, China, 650032

Beijing Ditan Hospital

Beijing, China, 100015

No. 302 PLA Hospital

Beijing, China, 100039

Peking University People's Hospital

Beijing, China, 100044

Beijing Friendship Hospital, Capital Medical University

Beijing, China, 100050

Beijing Youan Hospital, Capital Medical University

Beijing, China, 100069

XiangYa Hospital Central South University

Changsha, China, 410008

The 2nd Xiangya Hospital Central South University

Changsha, China, 410011

Guangzhou No.8 People's Hospital

Guangzhou, China, 510060

Nanfang Medical University, Nanfang Hospital

Guangzhou, China, 510515

The People's Hospital of Hainan Province

Haikou, China, 570311

Jiangsu Provincial People's Hospital

Nanjing, China, 210029

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, China, 200025

Shanghai Public Health Clinical Center

Shanghai, China, 200083

85 Hospital of People's Liberation Army

Shanghai, China, 200235

Shengjing Hospital of China Medical University

Shenyang, China, 110004

First Affiliated Hospital of Xi'an Jiaotong

Xi'an, China, 710061

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