Efficacy and Safety of Ombitasvir plus Paritaprevir/r combination regimen for Hepatitis C infected patients with immune disorders
Not Applicable
- Conditions
- Patients with genotype 1 HCV infection who have immune disorder
- Registration Number
- JPRN-UMIN000020302
- Lead Sponsor
- Hokkaido University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients with poorly controlled cardiac disease (e.g., myocardial infarction, cardiac failure, arrhythmia) 2)Patients with severe hepatic impairment 3)Patients with a history of hypersensitivity to HCV protease inhibitors or NS5A inhibitor 4)Patients with a concurrent malignancy, including hepatocellular carcinoma, at the start of treatment 5)Patients deemed unsuitable for study entry by their treating physician 6)Patients who are unsuitable, in the opinion of the principal investigator, for this study due to any other reason
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate efficacy (SVR12 rate) and safety of Ombitasvir / Paritaprevir/r therapy in CHC patients with immune disorders (cryoglobulinemia or Sjogrens syndrome)
- Secondary Outcome Measures
Name Time Method To assess the effect of HCV treatment on the status of immune disorders (cryoglobulinemia or Sjogrens syndrome). 2)mutations as viral factors on virologic response 3)Rate of emergence of drug-resistant variants 4)Presence or absence of a reversal of liver fibrosis 5)Presence or absence of an improvement in AFP levels 6)Effects of glucose/lipid-related factors on treatment response