Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C (PEGIFN)

Xiamen Amoytop Biotech

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: Peginterferon alfa-2a; Drug: Ypeginterferon alfa-2b

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01140997

TB1006IFN

Details and patient eligibility

About

This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess the efficacy and safety of Ypeginterferon alfa-2b (with Ribavirin), once a week, in 3 dose-groups respectively, for treatment of Chronic Hepatitis C patients, with Pegasys 180mcg/week & Ribavirin as positive control. It is aimed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase III trials, and generate the PK data in hepatitis C patients to satisfy regulatory requirements.

Enrollment: 211 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18~65 years.
• Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the cessation of treatment.
• Chronic HCV infection evidence: HCV RNA or anti-HCV positive >6 months; liver biopsy evidence; vital signs, symptoms, exposure history, and results of laboratory test and iconography examination support diagnosis of chronic hepatitis C.
• HCV RNA≥2000IU/ml.

Exclusion criteria

• Pregnant or lactating women.
• Mental disorder or physical disability.
• WBC<3000/mm3, or ANC <1500/mm3, or PLT <90,000/mm3.
• Received interferon treatment within the previous 6 months or shew no response to interferon.
• Co-infection with HIV, HAV, HBV, HEV.
• Evidence of hepatic decompensation.
• Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
• History of hypothyroidism or current treatment for thyroid disease.
• Diabetes mellitus.
• Uncontrolled significant chronic medical conditions other than chronic hepatitis C or other conditions which in the opinion of the investigator preclude enrollment into the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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211 participants in 4 patient groups

Group 1

Experimental group

Description:

Ypeginterferon alfa-2b 90mcg per Week, with Ribavirin 1000-1200mg/d

Treatment:

Drug: Ypeginterferon alfa-2b

Group 2

Experimental group

Description:

Ypeginterferon alfa-2b 135mcg per Week, with Ribavirin 1000-1200mg/d

Treatment:

Drug: Ypeginterferon alfa-2b

Group 3

Experimental group

Description:

Ypeginterferon alfa-2b 180mcg per Week, with Ribavirin 1000-1200mg/d

Treatment:

Drug: Ypeginterferon alfa-2b

Group 4

Active Comparator group

Description:

Pegasys 180mcg per Week, with Ribavirin 1000-1200mg/d

Treatment:

Drug: Peginterferon alfa-2a