Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B

Xiamen Amoytop Biotech

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis B

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01143662

TB1007IFN

Details and patient eligibility

About

This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess efficacy and safety of Ypeginterferon alfa-2b, once a week, in 3 dose-groups: 90mcg, 135mcg and 180mcg, respectively, for treatment of chronic hepatitis B characterized by HBeAg positivity, with Pegasys 180mcg/week 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 pharmacokinetic data of Ypeginterferon alfa-2b in hepatitis B patients to satisfy regulatory requirements.

Enrollment: 205 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age:18~60 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.
• Serum HBsAg positive for at least 6 months.
• Serum HBeAg positive with HBV DNA ≥20,000IU/ml.
• 2×ULN≤ALT≤10×ULN at screening(ULN=upper limit of normal).

Exclusion criteria

• Pregnant or lactating women.
• Mental disorder or physical disability.
• Interferon treatment history or using nucleos(t)ide analogue for chronic hepatitis B treatment within the previous 6 months.
• WBC<3000/mm3, or ANC <1500/mm3, or PLT <90,000/mm3.
• Co-infection with HAV, HIV, HCV, HDV, HEV.
• Both HBsAg and anti-HBs are positive, or both HBeAg and anti-HBe are positive at screening.
• Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
• Evidence of hepatic decompensation.
• History of hypothyroidism or current treatment for thyroid disease.
• Uncontrolled significant chronic medical conditions other than chronic hepatitis B, 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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205 participants in 4 patient groups

Group 1

Experimental group

Description:

Ypeginterferon alfa-2b 90mcg per week

Treatment:

Drug: Ypeginterferon alfa-2b

Group 2

Experimental group

Description:

Ypeginterferon alfa-2b 135mcg per week

Treatment:

Drug: Ypeginterferon alfa-2b

Group 3

Experimental group

Description:

Ypeginterferon alfa-2b 180mcg per week

Treatment:

Drug: Ypeginterferon alfa-2b

Group 4

Active Comparator group

Description:

Pegasys 180mcg per week

Treatment:

Drug: Peginterferon alfa-2a