Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Negative for Hepatitis B e Antigen

Trial ID or NCT#

NCT01940341

Status

not recruiting iconNOT RECRUITING

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)-negative 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-Negative, Chronic Hepatitis B

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  2. * 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 Baseline.* Adequate renal function.* Normal electrocardiogram (ECG).
    1. Key
Exclusion Criteria:
  1. * 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, human immunodeficiency 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.
    1. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Investigator(s)

Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Hepatologist, Transplant hepatologist
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health

Contact us to find out if this trial is right for you.

Contact

SPECTRUM
650-498-6084

View on ClinicalTrials.gov