LAST UPDATED
October 15, 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 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.
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 - March 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
- 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 Friendship Hospital, Capital Medical University
Beijing, China, 100050
Beijing Youan Hospital, Capital Medical University
Beijing, China, 100069
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 Second Xiangya Hospital of Central South University
Hunan, China, 410011
The First Affiliated Hospital of Nanchang University
Jiangxi, China, 330006
Ruijin Hospital, JiaoTong University School of Medicine
Shanghai, China, 200025
Shengjing Hospital of China Medical University
Shenyang, China, 110004
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China, 710061
1st Affiliated Hospital Kunming Medical College
Yunnan, China, 650032
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