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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000692

Enrollment

260

Registered

2007-04-26

Start date

2007-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic hepatitis B

Interventions

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-positiv

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged over 20 years-old with serum HBs antigen-positive,HBs Ab (Antibody)-negative of screening,elevated ALT twice within 180 days,and proven chronic hepatitis B. 1) HBe antigen-positive patients:HBsAg-positive,HBsAb-negative,DNA polymerase-positive,HBV-DNA=>5.7 log copies/mL 2) HBe antigen-negative patients : HBe antigen-negative,HBV-DNA=>5.0 log copies/mL

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
(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	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026