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About
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.
Full description
This study GS-US-320-0110 is a multi-center clinical trial planned to enroll participants in multiple 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 cohort are registered separately (NCT02836249) on ClinicalTrials.gov as this cohort will not be part of the main study analysis.
Enrollment
Sex
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Inclusion and exclusion criteria
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:
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 electrocardiogram (ECG).
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
875 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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