Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Positive 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 Positive, Chronic Hepatitis B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836249
• Other study ID #: GS-US-320-0110 (China)
• Secondary ID: 2013-000636-10
• Status: Completed
• Phase: Phase 3
• Start date: June 19, 2015
• Est. completion date: July 13, 2023

Study information

• Verified date: August 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)-positive chronic hepatitis B virus (HBV) infection in China.

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 information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: July 13, 2023
• Est. primary completion date: December 15, 2016
• 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

• 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 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	PLA 302 Hospital	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	Jiangsu Province People's Hospital	Jiangsu
China	The First Affiliated Hospital of Nanchang University	Jiangxi
China	1st Hospital Jilin University	Jilin
China	Jinan Infectious Disease Hospital	Jinan
China	2nd Hospital of Nanjing City	Nanjing
China	85 Hospital of People's Liberation Army	Shanghai
China	Ruijin Hospital, JiaoTong 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
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

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	Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) 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 at Week 48 in Serum Creatinine		Baseline; Week 48

External Links

•   Gilead Clinical Trials Website