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



Status:Active, not recruiting
Conditions:HIV / AIDS, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:September 2013
End Date:January 2024

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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

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.

This study GS-US-320-0108 is an international study planned to enroll participants in global
countries, including China. However, due to the review timeline difference in China, full
enrollment was reached in the main study before China was able to participate. Therefore,
details for the China cohorts were registered separately (NCT02836236) on ClinicalTrials.gov
as these cohorts will not be part of the main study analysis.

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.
We found this trial at
15
sites
Clayton, Victoria 3168
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Baltimore, Maryland 21229
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Detroit, Michigan 48202
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Flushing, New York 11355
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Flushing, New York
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Hillsborough, New Jersey 08844
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Hillsborough, NJ
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Los Angeles, California 90057
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Los Angeles, CA
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Palo Alto, California 94304
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Pasadena, California 91105
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Philadelphia, Pennsylvania 19107
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Philadelphia, PA
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Richmond, Virginia 23249
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Richmond, VA
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San Diego, California 92105
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San Diego, CA
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500 Parnassus Ave
San Francisco, California 94143
(415) 476-9000
University of California at San Francisco (UCSF) The leading university exclusively focused on health, UC...
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San Jose, California 95128
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San Jose, CA
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