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 Positive, 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)-positive chronic hepatitis B virus (HBV) infection in China.

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

Medical Condition

HBV, Chronic HBV Infections

Gender

N/A

Date

June 2015 - December 2016

Study Type

Interventional

Study Phase

Phase 3

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

Locations

Locations (25)

Beijing Ditan Hospital

Beijing, China, 100015

PLA 302 Hospital

Beijing, China, 100039

Beijing Friendship Hospital, Capital Medical University

Beijing, China, 100050

Beijing Youan Hospital, Capital Medical University

Beijing, China, 100069

Xianya Hospital, Central South University

Changsha, China, 410008

Guangzhou Eighth People's Hospital

Guangzhou, China, 510060

Nanfang Medical University, Nanfang Hospital

Guangzhou, China, 510515

No. 3 Hospital, Zhongshan Medical University

Guangzhou, China, 510630

The Affiliated Hospital of Guiyang Medical College

Guiyang, China, 550004

The People's Hospital of Hainan Province

Haikou, China, 570311

The Second Xiangya Hospital of Central South University

Hunan, China, 410011

Jiangsu Province People's Hospital

Jiangsu, China, 210029

The First Affiliated Hospital of Nanchang University

Jiangxi, China, 330006

1st Hospital Jilin University

Jilin, China, 130021

Jinan Infectious Disease Hospital

Jinan, China, 250021

2nd Hospital of Nanjing City

Nanjing, China, 210003

Ruijin Hospital, JiaoTong 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

The Sixth People's Hospital of Shenyang

Shenyang, China, 110006

3rd Hospital of Hebei Medical University

Shijiazhuang, China, 050051

West China Hospital, Sichuan University

Sichuan, China, 610041

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China, 710061

1st Affiliated Hospital Kunming Medical College

Yunnan, China, 650032

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