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

Phase 3

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: Ypeginterferon alfa-2b; Drug: Pegasys

• Registration Number: NCT01581398
• Lead Sponsor: Xiamen Amoytop Biotech Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-16
• Status Verified: 2012-04
• Study Start: 2012-04
• Study First Submitted QC: 2012-04-18
• Study First Posted: 2012-04-20
• Primary Completion: 2014-04
• Study Completion: 2014-06
• Last Update Submitted: 2014-10-06
• Last Update Posted: 2014-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 770

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A1(Genotype2/3)	Ypeginterferon alfa-2b	Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 800mg/day
A2(Genotype 2/3)	Pegasys	Pegasys 180μg/week, in combination with Ribavirin 800mg/day
B1(Non-genotype 2/3)	Ypeginterferon alfa-2b	Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight
B2(Non-genotype 2/3)	Pegasys	Pegasys 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with sustained virologic response (defined as HCV RNA<15IU/ml at 24 weeks after the end of therapy)	24 weeks after the end of therapy

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with HCV RNA undetectable (defined as HCV RNA <15IU/ml)	at weeks 4, 12, 24 for genotype 2/3, and weeks 4, 12, 24 and 48 for non-genotype 2/3

Trial Locations

Locations (42)

302 Military Hospital; 🇨🇳 Beijing, China

Beijing Youan Hospital, Capital Medical University; 🇨🇳 Beijing, China

Beijing Youyi Hospital, capital Medical University; 🇨🇳 Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, China

First Affiliated Hospital of Jilin University; 🇨🇳 Changchun, China

Xiangya Hospital, Central-south University; 🇨🇳 Changsha, China

Xiangya Second Hospital, Central-south University; 🇨🇳 Changsha, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, China

Second Affiliated Hospital Chongqing Medical University; 🇨🇳 Chongqing, China

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