LAST UPDATED
October 02, 2024
Clinicaltrials.gov ID
EudraCT ID
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.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
HBV, Chronic HBV Infection
Gender
N/A
Date
June 2015 - April 2017
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
- 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 Municipality, 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 Zhuang, 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
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
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
No.1 Hospital Affiliated to Kunming Medical College
Kunming, Yunnan, China, 650032
Beijing Friendship Hospital, Capital Medical University
Beijing, China, 100050
Beijing Youan Hospital, Capital Medical University
Beijing, China, 100069
The 2nd Xiangya Hospital Central South University
Changsha, China, 410011
Nanfang Medical University, Nanfang Hospital
Guangzhou, China, 510515
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200025
Shengjing Hospital of China Medical University
Shenyang, China, 110004
Join Gilead Trial Connect and help advance clinical research. Your participation is key to developing future treatments.
Share Trial