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Trial record 63 of 315 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02979613
First received: November 29, 2016
Last updated: July 13, 2017
Last verified: July 2017
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 48, as Determined by the Modified US FDA-Defined Snapshot Algorithm [ Time Frame: Week 48 ]

Secondary Outcome Measures:
  • 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 ]
  • Proportion of Participants with HBV DNA < 20 IU/mL (Target Detected/Not Detected) at Week 48, as Determined by the Modified US FDA-Defined Snapshot Algorithm [ Time Frame: Weeks 48 ]
  • Proportion of Participants with HBV DNA < 20 IU/mL (Target Detected/Not Detected) at Week 96, as Determined by the Modified US FDA-Defined Snapshot Algorithm [ Time Frame: Week 96 ]
  • Proportion of Participants with Hepatitis B e Antigen (HBeAg) Loss at Week 48 [ Time Frame: Week 48 ]
  • Proportion of Participants with Seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe) at Week 48 [ Time Frame: Week 48 ]
  • Proportion of Participants with HBeAg Loss at Week 96 [ Time Frame: Week 96 ]
  • Proportion of Participants with Seroconversion to Anti-HBe at Week 96 [ Time Frame: Week 96 ]
  • Proportion of Participants with Hepatitis B s Antigen (HBsAg) Loss at Week 48 [ Time Frame: Week 48 ]
  • Proportion of Participants with Seroconversion to Anti-Hepatitis B s-Antigen (Anti-HBs) at Week 48 [ Time Frame: Week 48 ]
  • Proportion of Participants with HBsAg Loss at Week 96 [ Time Frame: Week 96 ]
  • Proportion of Participants with Seroconversion to Anti-HBs at Week 96 [ Time Frame: Week 96 ]
  • Proportion of Participants with Normal Alanine Aminotransferase (ALT) at Week 48 (by Central Laboratory and the American Association for the Study of Liver Diseases (AASLD) Criteria) [ Time Frame: Week 48 ]
  • Proportion of Participants with Normalized ALT at Week 48 (by Central Laboratory and AASLD criteria) [ Time Frame: Week 48 ]
  • Proportion of Participants with Normal ALT at Week 96 (by Central Laboratory and the AASLD Criteria) [ Time Frame: Week 96 ]
  • Proportion of Participants with Normalized ALT at Week 96 (by Central Laboratory and AASLD criteria) [ Time Frame: Week 96 ]
  • Change from Baseline in Fibrosis as Assessed by FibroTest® at Week 48 [ Time Frame: Week 48 ]
  • Change from Baseline in Fibrosis as Assessed by FibroTest® at Week 96 [ Time Frame: Week 96 ]
  • Percent Change from Baseline in Hip Bone Mineral Density (BMD) at Week 48 [ Time Frame: Week 48 ]
  • Percent Change from Baseline in Hip BMD at Week 96 [ Time Frame: Week 96 ]
  • Percent Change from Baseline in Spine BMD at Week 48 [ Time Frame: Week 48 ]
  • Percent Change from Baseline in Spine BMD at Week 96 [ Time Frame: Week 96 ]
  • Change from Baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) at Week 48 [ Time Frame: Week 48 ]
  • Change from Baseline in eGFR-CG at Week 96 [ Time Frame: Week 96 ]

Estimated Enrollment: 460
Actual Study Start Date: December 29, 2016
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: September 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)
Sexes 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:

    • Hemoglobin < 10 g/dL
    • Absolute neutrophil count < 750/mm^3
    • 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

Locations
United States, California
Recruiting
Los Angeles, California, United States
Recruiting
Palo Alto, California, United States
Recruiting
Pasadena, California, United States
Recruiting
San Diego, California, United States
Recruiting
San Francisco, California, United States
Recruiting
San Jose, California, United States
United States, Maryland
Recruiting
Baltimore, Maryland, United States
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States
United States, Michigan
Recruiting
Novi, Michigan, United States
United States, New York
Recruiting
Flushing, New York, United States
Recruiting
New York, New York, United States
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States, 19107
Recruiting
Philadelphia, Pennsylvania, United States
United States, Tennessee
Recruiting
Nashville, Tennessee, United States
Canada
Recruiting
Toronto, Canada
Recruiting
Vancouver, Canada
Korea, Republic of
Recruiting
Seoul, Korea, Republic of, 05505
Recruiting
Seoul, Korea, Republic of, 135-710
Spain
Recruiting
Majadahonda, Spain
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 ( EudraCT Number )
Study First Received: November 29, 2016
Last Updated: July 13, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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 August 18, 2017