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Trial record 65 of 348 for:    hepatitis b | Open Studies

Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2016 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02979613
First received: November 29, 2016
Last updated: NA
Last verified: November 2016
History: No changes posted
  Purpose
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching to tenofovir alafenamide (TAF) versus continuing tenofovir disoproxil fumarate (TDF) in virologically suppressed adults with chronic hepatitis B virus (HBV) infection.

Condition Intervention Phase
Chronic Hepatitis B
Drug: TAF
Drug: TDF
Drug: TAF Placebo
Drug: TDF Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Switching From Tenofovir Disoproxil Fumarate (TDF) 300 mg QD to Tenofovir Alafenamide (TAF) 25mg QD in Subjects With Chronic Hepatitis B Who Are Virologically Suppressed

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Proportion of Participants with HBV DNA ≥ 20 IU/mL at Week 24, as Determined by the Modified US FDA-Defined Snapshot Algorithm [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of Participants with HBV DNA ≥ 20 IU/mL at Week 48, as Determined by the Modified US FDA-Defined Snapshot Algorithm [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Proportion of Participants with HBV DNA ≥ 20 IU/mL at Week 96, as Determined by the Modified US FDA-Defined Snapshot Algorithm [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Proportion of Participants with HBV DNA < 20 IU/mL (Target Not Detected) at Week 24, as Determined by the Modified US FDA-Defined Snapshot Algorithm [ Time Frame: Weeks 24 ] [ Designated as safety issue: No ]
  • Proportion of Participants with HBV DNA < 20 IU/mL (Target Not Detected) at Week 48, as Determined by the Modified US FDA-Defined Snapshot Algorithm [ Time Frame: Weeks 48 ] [ Designated as safety issue: No ]
  • Proportion of Participants with HBV DNA < 20 IU/mL (Target Not Detected) at Week 96, as Determined by the Modified US FDA-Defined Snapshot Algorithm [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Proportion of Participants with Hepatitis B e Antigen (HBeAg) Loss at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Proportion of Participants with Seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Proportion of Participants with HBeAg Loss at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Proportion of Participants with Seroconversion to Anti-HBe at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Proportion of Participants with HBeAg Loss at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Proportion of Participants with Seroconversion to Anti-HBe at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Proportion of Participants with Hepatitis B s Antigen (HBsAg) Loss at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Proportion of Participants with Seroconversion to Anti-Hepatitis B s-Antigen (Anti-HBs) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Proportion of Participants with HBsAg Loss at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Proportion of Participants with Seroconversion to Anti-HBs at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Proportion of Participants with HBsAg Loss at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Proportion of Participants with Seroconversion to Anti-HBs at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Proportion of Participants with Normal Alanine Aminotransferase (ALT) at Week 24 (by Central Laboratory and the American Association for the Study of Liver Diseases (AASLD) Criteria) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Proportion of Participants with Normalized ALT at Week 24 (by Central Laboratory and the AASLD Criteria) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Proportion of Participants with Normal ALT at Week 48 (by Central Laboratory and the AASLD Criteria) [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Proportion of Participants with Normalized ALT at Week 48 (by Central Laboratory and AASLD criteria) [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Proportion of Participants with Normal ALT at Week 96 (by Central Laboratory and the AASLD Criteria) [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Proportion of Participants with Normalized ALT at Week 96 (by Central Laboratory and AASLD criteria) [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Change from Baseline in Fibrosis as Assessed by FibroTest® at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Change from Baseline in Fibrosis as Assessed by FibroTest® at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Percent Change from Baseline in Hip Bone Mineral Density (BMD) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
  • Percent Change from Baseline in Hip BMD at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Percent Change from Baseline in Hip BMD at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]
  • Percent Change from Baseline in Spine BMD at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
  • Percent Change from Baseline in Spine BMD at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Percent Change from Baseline in Spine BMD at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
  • Change from Baseline in eGFR-CG at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Change from Baseline in eGFR-CG at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: December 2016
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAF
TAF + TDF placebo for 48 weeks
Drug: TAF
25 mg tablet administered orally once daily
Other Names:
  • Vemlidy®
  • GS-7340
Drug: TDF Placebo
Tablet administered orally once daily
Active Comparator: TDF
TDF + TAF placebo for 48 weeks
Drug: TDF
300 mg tablet administered orally once daily
Other Name: Viread®
Drug: TAF Placebo
Tablet administered orally once daily
Experimental: Open-Label Extension
Participants who complete 48 weeks of treatment are eligible for participation in the open-label extension period to receive TAF for an additional 48 weeks.
Drug: TAF
25 mg tablet administered orally once daily
Other Names:
  • Vemlidy®
  • GS-7340

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
  • Adult male and non-pregnant, non-lactating females
  • Documented evidence of chronic HBV infection previously
  • Maintained on TDF 300 mg QD for at least 48 weeks, and as monotherapy for chronic hepatitis B for at least 24 weeks with viral suppression (HBV DNA < LLOQ) for a minimum of 12 weeks prior to screening
  • Adequate renal function
  • Normal ECG

Key Exclusion Criteria:

  • Pregnant women or women 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 (HCV), hepatitis D virus (HDV), or HIV
  • Evidence of hepatocellular carcinoma
  • Current evidence of, or recent (≤ 5 year) history of clinical hepatic decompensation
  • Abnormal hematological and biochemical parameters, including:

    • Platelets ≤ 50,000/mm^3
    • Aspartate aminotransferase (AST) or ALT > 5 × upper limit of the normal range (ULN)
    • Albumin < 3.0 mg/ dL
    • International normalized ratio (INR) > 1.5 × ULN (unless stable on anticoagulant regimen)
    • Total bilirubin > 2.5 × ULN
  • Received solid organ or bone marrow transplant
  • Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (eg, basal cell skin cancer). Individuals under evaluation for possible malignancy are not eligible.
  • Currently receiving therapy with immunomodulators (eg, corticosteroids), 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 compliance
  • Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements.
  • Use of investigational agents within 3 months of screening, unless allowed by the sponsor

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02979613

Contacts
Contact: Gilead Study Team GS-US-320-4018@gilead.com

Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02979613     History of Changes
Other Study ID Numbers: GS-US-320-4018  2016-003632-20 
Study First Received: November 29, 2016
Last Updated: November 29, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Hong Kong: Department of Health
Italy: The Italian Medicines Agency
South Korea: Ministry of Food and Drug Safety
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Taiwan : Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on January 17, 2017