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

Not Recruiting

Trial ID: NCT01940471

Purpose

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.

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

Stanford Investigator(s)

Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD

Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health

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.

Intervention(s):

drug: TAF

drug: TDF

drug: TAF Placebo

drug: TDF Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
SPECTRUM
650-498-6474