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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02836249
Recruitment Status : Active, not recruiting
First Posted : July 18, 2016
Results First Posted : April 17, 2018
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
HBV Chronic HBV Infections Drug: TAF Drug: TDF Drug: TAF Placebo Drug: TDF Placebo Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 19, 2015
Actual Primary Completion Date : December 15, 2016
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TAF
TAF + TDF placebo for up to 144 weeks
 Drug: TAF
TAF 25 mg tablet administered orally once daily
Other Names:
  • GS-7340
  • Vemlidy®

Drug: TDF Placebo
TDF placebo tablet administered orally once daily
Active Comparator: TDF
TDF + TAF placebo for up to 144 weeks
 Drug: TDF
TDF 300 mg tablet administered orally once daily
Other Name: Viread®

Drug: TAF Placebo
TAF placebo tablet administered orally once daily
Experimental: 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.
 Drug: TAF
TAF 25 mg tablet administered orally once daily
Other Names:
  • GS-7340
  • Vemlidy®


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48 [ Time Frame: Week 48 ]

Secondary Outcome Measures :
  1. Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) at Week 48 [ Time Frame: Week 48 ]
  2. Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 [ Time Frame: Baseline; Week 48 ]
  3. Percent Change From Baseline in Spine BMD at Week 48 [ Time Frame: Baseline; Week 48 ]
  4. Change From Baseline at Week 48 in Serum Creatinine [ Time Frame: Baseline; Week 48 ]

Other Outcome Measures:
  1. Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48 [ Time Frame: Up to 48 weeks ]
    Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836249


Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02836249    
Other Study ID Numbers: GS-US-320-0110 (China)
2013-000636-10 ( EudraCT Number )
First Posted: July 18, 2016    Key Record Dates
Results First Posted: April 17, 2018
Last Update Posted: February 17, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gilead Sciences:
Hepatitis
Tenofovir
Viread
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections