Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Positive Hepatitis B (China)
- Registration Number
- NCT02836249
- 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)-positive chronic hepatitis B virus (HBV) infection in China.
- Detailed Description
This study GS-US-320-0110 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 (NCT01940471) 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 181
-
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
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 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). 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). 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 Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) at Week 48 Week 48 Change From Baseline at Week 48 in Serum Creatinine Baseline; Week 48
Trial Locations
- Locations (25)
Beijing Ditan Hospital
🇨🇳Beijing, China
PLA 302 Hospital
🇨🇳Beijing, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, China
Beijing Youan Hospital, Capital Medical University
🇨🇳Beijing, China
Xianya Hospital, Central South University
🇨🇳Changsha, China
Guangzhou Eighth People's Hospital
🇨🇳Guangzhou, China
Nanfang Medical University, Nanfang Hospital
🇨🇳Guangzhou, China
No. 3 Hospital, Zhongshan Medical University
🇨🇳Guangzhou, China
The Affiliated Hospital of Guiyang Medical College
🇨🇳Guiyang, China
The People's Hospital of Hainan Province
🇨🇳Haikou, China
The Second Xiangya Hospital of Central South University
🇨🇳Hunan, China
The First Affiliated Hospital of Nanchang University
🇨🇳Jiangxi, China
1st Hospital Jilin University
🇨🇳Jilin, China
Jinan Infectious Disease Hospital
🇨🇳Jinan, China
Jiangsu Province People's Hospital
🇨🇳Nanjing, China
2nd Hospital of Nanjing City
🇨🇳Nanjing, China
Ruijin Hospital, JiaoTong University School of Medicine
🇨🇳Shanghai, China
Shanghai Public Health Clinical Center
🇨🇳Shanghai, China
85 Hospital of People's Liberation Army
🇨🇳Shanghai, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, China
The Sixth People's Hospital of Shenyang
🇨🇳Shenyang, China
3rd Hospital of Hebei Medical University
🇨🇳Shijiazhuang, China
West China Hospital, Sichuan University
🇨🇳Sichuan, China
First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, China
1st Affiliated Hospital Kunming Medical College
🇨🇳Yunnan, China