JPRN-UMIN000031832
Completed
Phase 4
Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF) - Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)
Stanford University Medical Center0 sites270 target enrollmentMarch 22, 2018
ConditionsChronic hepatitis B
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Chronic hepatitis B
- Sponsor
- Stanford University Medical Center
- Enrollment
- 270
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1 Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study 2 Previous recipient of a liver transplant 3 Co\-infection with human immunodeficiency virus (HIV) or hepatitis C (HCV) or hepatitis D (HDV) 4 Severe or uncontrolled comorbidities 5 Current or known hepatic decompensation (below 2 years) (e.g ascites, encephalopathy, or variceal hemorrhage) with a Child\-Pugh score of B or C 6 Malignancy including liver cancer within 5 years except cancers curable by surgical resection (e.g. basal cell skin cancer and squamous cell cancer) 7 On any of the disallowed concomitant medications listed in the prior and concomitant medications list (pg. 11\). Subjects on prohibited medications who are otherwise eligible will need a wash out period of at least 30 days prior to the Screening/Baseline visit. 8 Males and females of reproductive potential who are unwilling to use "effective" protocol\-specified method(s) of contraception during the study. 9 Current substance or alcohol abuse judged by the investigator to potentially interfere with subject compliance. 10 Any other clinical conditions that, in the opinion of the Investigator, would make the subject unsuitable or unable to comply with any of the study procedures
Outcomes
Primary Outcomes
Not specified
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