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Not Recruiting
Trial ID: NCT01940341
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
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health
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.
drug: TAF
drug: TDF
drug: TAF Placebo
drug: TDF Placebo
Not Recruiting
Stanford University
School of Medicine
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Stanford,
CA
94305
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