Prospective observational study on efficacy and safety of PEGASYS for the treatment of patients with HBeAg positive or HBeAg negative chronic active hepatitis B
Not Applicable
- Conditions
- Chronic active hepatitis B (CHB)
- Registration Number
- JPRN-UMIN000008045
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
The incidence of ADRs in the 536 patients in the safety analysis set was 47.76% (256/536 patients), with 565 events reported. By system organ class (SOC), the most common ADRs (5% incidence) in the 536 patients in the safety analysis set were investigations (28.92%, 155/536 patients), general disorders and administration site condition (12.31%, 66/536 patients), and skin and subcutaneous tissue disorders (9.33%, 50/536 patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 536
Inclusion Criteria
Not provided
Exclusion Criteria
chronic active hepatitis B patients without HBeAg data
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method