Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Positive Hepatitis B
Last updated on April 2022Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 864
Exclusion Criteria
- Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study
- Evidence of hepatocellular carcinoma
- Co-infection with hepatitis C virus, HIV, or hepatitis D virus
- ...
- Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study
- Evidence of hepatocellular carcinoma
- Co-infection with hepatitis C virus, HIV, or hepatitis D virus
- Females who are breastfeeding
- Currently receiving therapy with immunomodulators (eg, corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion
- 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
- Abnormal hematological and biochemical parameters, including aspartate aminotransferase (AST) > 10 x ULN
- 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
- 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
- Received solid organ or bone marrow transplant
- Any history of, or current evidence of, clinical hepatic decompensation
- Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance
Summary
- Conditions
- Chronic HBV Infection
- HBV
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This study GS-US-320-0110 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 cohor...
This study GS-US-320-0110 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 (NCT02836249) on ClinicalTrials.gov as these cohorts will not be part of the main study analysis.
Exclusion Criteria
- Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study
- Evidence of hepatocellular carcinoma
- Co-infection with hepatitis C virus, HIV, or hepatitis D virus
- ...
- Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study
- Evidence of hepatocellular carcinoma
- Co-infection with hepatitis C virus, HIV, or hepatitis D virus
- Females who are breastfeeding
- Currently receiving therapy with immunomodulators (eg, corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion
- 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
- Abnormal hematological and biochemical parameters, including aspartate aminotransferase (AST) > 10 x ULN
- 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
- 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
- Received solid organ or bone marrow transplant
- Any history of, or current evidence of, clinical hepatic decompensation
- Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance
Tracking Information
- NCT #
- NCT01940471
- Collaborators
- Not Provided
- Investigators
- Study Director: Gilead Study Director Gilead Sciences
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