A phase II/III clinical study of R442(Pegylated Interferon alfa-2a) for patients with chronic hepatitis B.

Phase 2

• Conditions: chronic hepatitis B

• Registration Number: JPRN-UMIN000000692
• Lead Sponsor: CHUGAI PHARMACEUTICAL CO.LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-26
• Study Completion: 2010-11-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

Not provided

Exclusion Criteria

Neutrophil count <1,500 cells/mm3,platelet count < 90,000 cells/mm3, hemoglobin concentration <10 g/dL, hepatitis C co-infection, decompensated liver disease, history of organ transplant, creatinine clearance < 50 mL/min, sever psychiatric disease, diabetes needed pharmacotherapy, poorly controlled hypertention, malignant tumor, severe cardiac or chronic pulmonary disease, immunologically mediated disease, cerebral stroke or retinopathy. Treated by pegylated interferon in the past.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(1)HBe antigen-positive patients Combined response* after 24 weeks of follow-up *Defined by seroconversion to anti-HBe, hepatitis B virus(HBV)-DNA <5.0 log copies/mL and normalization of ALT (2)HBe antigen-negative patients. 1) HBV-DNA <4.3 log copies/mL after 24 weeks of follow-up 2) Normalization of ALT after 24 weeks of follow-up