Trial Search Results

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

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)-negative chronic hepatitis B virus (HBV) infection.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Gilead Sciences

Stanford Investigator(s):

Intervention(s):

  • Drug: TAF
  • Drug: TDF
  • Drug: TAF Placebo
  • Drug: TDF Placebo

Phase:

Phase 3

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

   - Hepatitis e antigen (HBeAg)-negative, chronic hepatitis B with all of the following:

      - HBeAg-negative and hepatitis B e antibody (HBeAb) 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting