Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B (China)
NCT ID: NCT02836236
Last Updated: 2024-10-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
155 participants
INTERVENTIONAL
2015-06-19
2023-09-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Double-Blind 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).
TAF
TAF 25 mg tablet administered orally once daily
TDF Placebo
TDF placebo tablet administered orally once daily
Double-Blind TDF
TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks (per amendment 3.1).
TDF
TDF 300 mg tablet administered orally once daily
TAF Placebo
TAF placebo tablet administered orally once daily
Open-label TAF
All participants who complete the double-blind period will be eligible to receive open-label TAF until Week 384 of the study.
TAF
TAF 25 mg tablet administered orally once daily
Interventions
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TAF
TAF 25 mg tablet administered orally once daily
TDF
TDF 300 mg tablet administered orally once daily
TAF Placebo
TAF placebo tablet administered orally once daily
TDF Placebo
TDF placebo tablet administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
The 1st Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi Zhuang, China
The Affiliated Hospital of Guiyang Medical College
Guiyang, Guiyang, China
The 3rd Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Tongji Hospital, Tongji Medical college HuaZhong University of Science&Technology
Wuhan, Hubei, China
Nanjing No. 2 Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
The sixth People's Hospital of Shenyang
Shenyang, Liaoning, China
Jinan Infectious Disease Hospital
Jinan, Shandong, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
No.1 Hospital Affiliated to Kunming Medical College
Kunming, Yunnan, China
Beijing Ditan Hospital
Beijing, , China
No. 302 PLA Hospital
Beijing, , China
Peking University People's Hospital
Beijing, , China
Beijing Friendship Hospital, Capital Medical University
Beijing, , China
Beijing Youan Hospital, Capital Medical University
Beijing, , China
XiangYa Hospital Central South University
Changsha, , China
The 2nd Xiangya Hospital Central South University
Changsha, , China
Guangzhou No.8 People's Hospital
Guangzhou, , China
Nanfang Medical University, Nanfang Hospital
Guangzhou, , China
The People's Hospital of Hainan Province
Haikou, , China
Jiangsu Provincial People's Hospital
Nanjing, , China
Rui Jin Hospital Shanghai Jiao Tong 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
First Affiliated Hospital of Xi'an Jiaotong
Xi'an, , China
Countries
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References
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Hou J, Ning Q, Duan Z, Chen Y, Xie Q, Wang FS, Zhang L, Wu S, Tang H, Li J, Lin F, Yang Y, Gong G, Flaherty JF, Gaggar A, Mo S, Cheng C, Camus G, Chen C, Huang Y, Jia J, Zhang M; GS-US-320-0110 and GS-US-320-0108 China Investigators. 3-year Treatment of Tenofovir Alafenamide vs. Tenofovir Disoproxil Fumarate for Chronic HBV Infection in China. J Clin Transl Hepatol. 2021 Jun 28;9(3):324-334. doi: 10.14218/JCTH.2020.00145. Epub 2021 Apr 28.
Hou J, Ning Q, Duan Z, Chen Y, Xie Q, Zhang L, Wu S, Tang H, Li J, Lin F, Yang Y, Gong G, Luo Y, Xie S, Wang H, Mateo R, Yazdi T, Abramov F, Yee LJ, Flaherty J, Chen C, Huang Y, Zhang M, Jia J. Five-year Treatment with Tenofovir Alafenamide Achieves High Rates of Viral Suppression, Alanine Aminotransferase Normalization, and Favorable Bone and Renal Safety in Chinese Chronic Hepatitis B Patients. J Clin Transl Hepatol. 2024 May 28;12(5):469-480. doi: 10.14218/JCTH.2023.00417. Epub 2024 Apr 15.
Lim YS, Chan HLY, Ahn SH, Seto WK, Ning Q, Agarwal K, Janssen HLA, Pan CQ, Chuang WL, Izumi N, Fung S, Shalimar, Brunetto M, Hui AJ, Chang TT, Lim SG, Abramov F, Flaherty JF, Wang H, Yee LJ, Kao JH, Gane E, Hou J, Buti M. Tenofovir alafenamide and tenofovir disoproxil fumarate reduce incidence of hepatocellular carcinoma in patients with chronic hepatitis B. JHEP Rep. 2023 Jul 13;5(10):100847. doi: 10.1016/j.jhepr.2023.100847. eCollection 2023 Oct.
Provided Documents
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Document Type: Study Protocol: Amendment 2.1
Document Type: Study Protocol: Amendment 3.1
Document Type: Study Protocol: Amendment 3.4
Document Type: Statistical Analysis Plan: Statistical Analysis Plan Week 48
Document Type: Statistical Analysis Plan: Statistical Analysis Plan Final
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2013-000626-63
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-320-0108 (China)
Identifier Type: -
Identifier Source: org_study_id
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