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

UMIN ID: UMIN000000692

Registered date:26/04/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: chronic hepatitis B
• Date of first enrollment: 2007/05/01
• Target sample size: 260
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

R442 180mcg once weekly for 48 weeks in HBe antigen-positive patients.
R442 90mcg once weekly for 48 weeks in HBe antigen-positive patients.
R442 180mcg once weekly for 24 weeks in HBe antigen-positive patients.
R442 90mcg once weekly for 24 weeks in HBe antigen-positive patients.
Interferon alfa 6MIU three times week for 24 weeks in HBe antigen-positive patients. (Unblinded)
R442 180mcg once weekly for 48 weeks in HBe antigen-negative patients.
R442 90mcg once weekly for 48 weeks in HBe antigen-negative patients.

Outcome(s)

• Primary Outcome: (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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: CHUGAI PHARMACEUTICAL CO.LTD.
• Source(s) of Monetary Support: CHUGAI PHARMACEUTICAL CO.LTD.