Investigation of hepatitis B virus reactivation after novel molecular targeted therapy with immunostimulatory effect (solid tumors)
Not Applicable
- Conditions
- Solid cancer, Hepatitis B
- Registration Number
- JPRN-UMIN000046853
- Lead Sponsor
- ational Institute for Medical Research and Development (AMED)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 321
Inclusion Criteria
Not provided
Exclusion Criteria
(Common to Cohort 1 and Cohort 2) 1) Have indicated their intention not to participate in this study 2) Have been judged ineligible for this study by the principal investigator at each institution
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of HBV Reactivation during Use of Novel Molecular Targeting Agents with Immunostimulatory Effects
- Secondary Outcome Measures
Name Time Method Changes in the amount of HBV during the use of new molecular target drugs with immunostimulating effects, primary disease, whether or not a nucleic acid analog was administered, details of chemotherapy, whether or not HCV was involved, the titer of HBS antigen, differences in the frequency of reactivation according to changes in HBV-related markers HBV reactivation frequency, presence or absence of HBV reactivation-related liver injury, presence or absence of immune-related liver injury requiring systemic steroid therapy, presence or absence of HBV reactivation-related fulminant liver injury HBV reactivation-related fulminant hepatitis incidence rate, non-compensated cirrhosis incidence rate, hepatocellular carcinoma incidence rate, HBV reactivation-related hepatotoxicity incidence rate after discontinuation of nucleoside analogues, and death