Efficacy and Safety Study of Peginterferon Alfa-2b in Chinese Chronic Hepatitis C Patients

Xiamen Amoytop Biotech

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C

Treatments: Drug: Ypeginterferon alfa-2b; Drug: Pegasys

Study type: Interventional

Funder types: Industry

Identifiers

NCT01581398

TB1203IFN

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of Peginterferon alfa-2b (40KD, Y shape, the followings will refer as Ypeginterferon alfa-2b for short), at a dose of 180μg/week, in combination with Ribavirin in Chinese chronic hepatitis C patients. The study will first group patients into two sub-study, genotype 2/3 and non-genotype 2/3, depending on the HCV genotype that infected. In the genotype 2/3 sub-study about 219 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 24 weeks of interferon therapy and oral daily Ribavirin at a dose of 800mg/d. In the non-genotype 2/3 sub-study about 507 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 48 weeks of interferon therapy and oral daily Ribavirin 1000-1200mg/day , basing on body weight. All patients will be followed for 24 weeks after the end of therapy.

Enrollment: 770 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18~65 years
• Hepatitis virus C chronic infection evidences: HCV RNA or anti-HCV positive>6 months,or other evidences supporting diagnosis of chronic hepatitis C infection
• HCV RNA≥2000IU/mL, anti-HCV positive at screening
• Pregnancy tests for female patients must be negative. All patients must take effective contraception measures during the study period
• Signed informed consent

Exclusion criteria

• Pregnant or lactating women
• Mental or psychology disorder
• ANC<1500/mm3, or PLT<90,000/mm3, or Hb<ULN(Upper limit of Normal)
• Received interferon treatment within the previous 6 months or shown no-response to previous interferon treatment
• Co-infection with HIV, HAV, HBV, HEV
• Evidence of hepatic decompensation (e.g: Child Plug≥B, prothrombin time prolonged more than 3 seconds, TBil>2ULN, Alb<35g/L)
• Hepatocarcinoma or suffering from any other malignant tumor
• Not well controlled endocrine diseases(e.g:thyroid disfunction, mellitus mellitus)
• Significant function damage in any major organs (e.g: heart, lung, kidney)
• Involved in other investigation within the previous 3 months
• Other conditions which in the opinion of the investigator precluding enrollment into the study (e.g: poor compliance)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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770 participants in 4 patient groups

A1(Genotype2/3)

Experimental group

Description:

Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 800mg/day

Treatment:

Drug: Ypeginterferon alfa-2b

Drug: Ypeginterferon alfa-2b

A2(Genotype 2/3)

Active Comparator group

Description:

Pegasys 180μg/week, in combination with Ribavirin 800mg/day

Treatment:

Drug: Pegasys

Drug: Pegasys

B1(Non-genotype 2/3)

Experimental group

Description:

Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight

Treatment:

Drug: Ypeginterferon alfa-2b

Drug: Ypeginterferon alfa-2b

B2(Non-genotype 2/3)

Active Comparator group

Description:

Pegasys 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight.

Treatment:

Drug: Pegasys

Drug: Pegasys