Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B (China)
- Registration Number
- NCT02836236
- Lead Sponsor
- Gilead Sciences
- Brief 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.
- Detailed Description
This study GS-US-320-0108 is an international study planned to enroll participants in global countries, including China. However, due to the review timeline difference in China, full enrollment was reached in the main study (NCT01940341) before China was able to participate. Therefore, this registration only includes the China cohorts as they were not part of the main study analysis. Data for China cohorts were analyzed separately after the main study analysis was completed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
-
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
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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
Key
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Double-Blind TAF TAF Tenofovir alafenamide (Vemlidy®; TAF) 25 mg tablet + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablet once daily for up to 144 weeks (per amendment 3.1). Double-Blind TAF TDF Placebo Tenofovir alafenamide (Vemlidy®; TAF) 25 mg tablet + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablet once daily for up to 144 weeks (per amendment 3.1). Double-Blind TDF TDF TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks (per amendment 3.1). Double-Blind TDF TAF Placebo TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks (per amendment 3.1). Open-label TAF TAF All participants who complete the double-blind period will be eligible to receive open-label TAF until Week 384 of the study.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48 Week 48
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 Baseline, Week 48 Percent Change From Baseline in Spine BMD at Week 48 Baseline, Week 48 Change From Baseline in Serum Creatinine at Week 48 Baseline, Week 48
Trial Locations
- Locations (29)
Beijing Ditan Hospital
🇨🇳Beijing, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, China
Beijing Youan Hospital, Capital Medical University
🇨🇳Beijing, China
85 Hospital of People's Liberation Army
🇨🇳Shanghai, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
The People's Hospital of Hainan Province
🇨🇳Haikou, China
Nanjing No. 2 Hospital
🇨🇳Nanjing, Jiangsu, China
The 3rd Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Jinan Infectious Disease Hospital
🇨🇳Jinan, Shandong, China
The Affiliated Hospital of Guiyang Medical College
🇨🇳Guiyang, Guiyang, China
The Third Affiliated Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
The sixth People's Hospital of Shenyang
🇨🇳Shenyang, Liaoning, China
Tongji Hospital, Tongji Medical college HuaZhong University of Science&Technology
🇨🇳Wuhan, Hubei, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
No.1 Hospital Affiliated to Kunming Medical College
🇨🇳Kunming, Yunnan, China
No. 302 PLA Hospital
🇨🇳Beijing, China
Peking University People's Hospital
🇨🇳Beijing, China
The 2nd Xiangya Hospital Central South University
🇨🇳Changsha, China
Nanfang Medical University, Nanfang Hospital
🇨🇳Guangzhou, China
Jiangsu Provincial People's Hospital
🇨🇳Nanjing, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
The 1st Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
XiangYa Hospital Central South University
🇨🇳Changsha, China
Guangzhou No.8 People's Hospital
🇨🇳Guangzhou, China
Shanghai Public Health Clinical Center
🇨🇳Shanghai, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, China
First Affiliated Hospital of Xi'an Jiaotong
🇨🇳Xi'an, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China