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

Last updated: August 24, 2020
Sponsor: Gilead Sciences
Overall Status: Completed

Phase

3

Condition

Hepatitis

Liver Disorders

Hepatitis B

Treatment

N/A

Clinical Study ID

NCT02979613
GS-US-320-4018
2016-003632-20
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Must have the ability to understand and sign a written informed consent form; consentmust be obtained prior to initiation of study procedures

  • Adult male and non-pregnant, non-lactating females

  • Documented evidence of chronic hepatitis B virus (HBV) infection previously

  • Maintained on tenofovir disoproxil fumarate (TDF) 300 mg once daily for at least 48weeks, and as monotherapy for chronic hepatitis B for at least 24 weeks with viralsuppression (HBV DNA < lower limit of quantitation) for a minimum of 12 weeks prior toscreening

  • Adequate renal function

  • Normal Electrocardiogram

Exclusion

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 humanimmunodeficiency virus (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 alanine aminotransferase (ALT) > 5 × upperlimit of the normal (ULN)

  • Albumin < 3.0 mg/ dL

  • International normalized ratio (INR) > 1.5 × ULN (unless stable on anticoagulantregimen)

  • Total bilirubin > 2.5 × ULN

  • Received solid organ or bone marrow transplant

  • Malignancy within 5 years prior to screening, with the exception of specific cancersthat are cured by surgical resection (eg, basal cell skin cancer). Individuals underevaluation for possible malignancy are not eligible.

  • Currently receiving therapy with immunomodulators (eg, corticosteroids), nephrotoxicagents, or agents capable of modifying renal excretion

  • Individuals receiving ongoing therapy with drugs not to be used with TAF or TDF orindividuals with a known hypersensitivity to study drugs, metabolites, or formulationexcipients

  • Current alcohol or substance abuse judged by the investigator to potentially interferewith compliance

  • Any other clinical condition or prior therapy that, in the opinion of theinvestigator, would make the individual unsuitable for the study or unable to complywith dosing requirements.

  • Use of investigational agents within 3 months of screening, unless allowed by thesponsor Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 490
Study Start date:
December 29, 2016
Estimated Completion Date:
January 30, 2020

Connect with a study center

  • Edmonton,
    Canada

    Site Not Available

  • Toronto,
    Canada

    Site Not Available

  • Vancouver,
    Canada

    Site Not Available

  • Hong Kong,
    Hong Kong

    Site Not Available

  • Kowloon,
    Hong Kong

    Site Not Available

  • Milan, 20122
    Italy

    Site Not Available

  • Goyang, Gyeonggi-d
    Korea, Republic of

    Site Not Available

  • Daegu, 700-721
    Korea, Republic of

    Site Not Available

  • empty

    Goyang-si, 411-706
    Korea, Republic of

    Site Not Available

  • Seoul, 152-703
    Korea, Republic of

    Site Not Available

  • Barcelona,
    Spain

    Site Not Available

  • Majadahonda,
    Spain

    Site Not Available

  • Chiayi City, 60002
    Taiwan

    Site Not Available

  • Kaohsiung,
    Taiwan

    Site Not Available

  • Taipei City, 10002
    Taiwan

    Site Not Available

  • London,
    United Kingdom

    Site Not Available

  • Los Angeles, California
    United States

    Site Not Available

  • Palo Alto, California
    United States

    Site Not Available

  • Pasadena, California
    United States

    Site Not Available

  • San Diego, California
    United States

    Site Not Available

  • San Francisco, California
    United States

    Site Not Available

  • San Jose, California
    United States

    Site Not Available

  • Baltimore, Maryland
    United States

    Site Not Available

  • Boston, Massachusetts
    United States

    Site Not Available

  • Novi, Michigan
    United States

    Site Not Available

  • Flushing, New York 11355
    United States

    Site Not Available

  • New York, New York
    United States

    Site Not Available

  • Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Nashville, Tennessee
    United States

    Site Not Available

  • Sugar Land, Texas 77478
    United States

    Site Not Available

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