Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for the treatment of CHC patients with compensated LC
- Conditions
- Chronic hepatitis C with compensated liver cirrhosis
- Registration Number
- JPRN-UMIN000006265
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
The safety analysis set included 487 of the 494 patients for whom case report forms were collected. This excluded 7 patients who were excluded from the safety analysis. The efficacy analysis set included 392 of the 487 patients in the safety analysis set. This excluded 95 patients who were excluded from the efficacy analysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 487
Not provided
All contraindications specified in the Japanese package insert of PEGASYS/COPEGUS must be adhered. The major exclusion criteria are: #Coadministration of Shosaikoto #Autoimmune hepatitis #Severe hepatic dysfunction #Unstable or uncontrolled cardiac disease #Hypersensitivity to peginterferon or ribavirin or to any of the excipients #Pregnancy (A pregnancy needs to be reliably ruled out before treatment initiation and reliably prevented during treatment, please see the Japanese package insert for PEGASYS/COPEGUS for further details) #Breast-feeding women #Hemoglobinopathies (e.g. thalassemia, sickle-cell anemia)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: HCV RNA unditectable at 24 weeks after treatment (sustained virological response, SVR)
- Secondary Outcome Measures
Name Time Method