Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B (China)

HBV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836236
• Other study ID #: GS-US-320-0108 (China)
• Secondary ID: 2013-000626-63
• Status: Completed
• Phase: Phase 3
• Start date: June 19, 2015
• Est. completion date: September 18, 2023

Study information

• Verified date: October 2023
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: September 18, 2023
• Est. primary completion date: February 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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

Key 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.

Related Conditions & MeSH terms

• Chronic HBV Infections
• HBV
• Hepatitis
• Hepatitis B

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Beijing Ditan Hospital	Beijing
China	Beijing Friendship Hospital, Capital Medical University	Beijing
China	Beijing Youan Hospital, Capital Medical University	Beijing
China	No. 302 PLA Hospital	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	The 2nd Xiangya Hospital Central South University	Changsha
China	XiangYa Hospital Central South University	Changsha
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Guangzhou No.8 People's Hospital	Guangzhou
China	Nanfang Medical University, Nanfang Hospital	Guangzhou
China	The Third Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	The Affiliated Hospital of Guiyang Medical College	Guiyang	Guiyang
China	The People's Hospital of Hainan Province	Haikou
China	Jinan Infectious Disease Hospital	Jinan	Shandong
China	No.1 Hospital Affiliated to Kunming Medical College	Kunming	Yunnan
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Provincial People's Hospital	Nanjing
China	Nanjing No. 2 Hospital	Nanjing	Jiangsu
China	The 1st Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	85 Hospital of People's Liberation Army	Shanghai
China	Rui Jin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai
China	Shanghai Public Health Clinical Center	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang
China	The sixth People's Hospital of Shenyang	Shenyang	Liaoning
China	The 3rd Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Tongji Hospital, Tongji Medical college HuaZhong University of Science&Technology	Wuhan	Hubei
China	First Affiliated Hospital of Xi'an Jiaotong	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48	Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method.	Up to 48 weeks
Primary	Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48		Week 48
Secondary	Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48		Baseline; Week 48
Secondary	Percent Change From Baseline in Spine BMD at Week 48		Baseline; Week 48
Secondary	Change From Baseline in Serum Creatinine at Week 48		Baseline; Week 48

External Links

•   Gilead Clinical Trials Website