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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01581398
First received: February 16, 2012
Last updated: October 6, 2014
Last verified: April 2012

February 16, 2012
October 6, 2014
April 2012
April 2014   (final data collection date for primary outcome measure)
Proportion of patients with sustained virologic response (defined as HCV RNA<15IU/ml at 24 weeks after the end of therapy) [ Time Frame: 24 weeks after the end of therapy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01581398 on ClinicalTrials.gov Archive Site
Proportion of patients with HCV RNA undetectable (defined as HCV RNA <15IU/ml) [ Time Frame: at weeks 4, 12, 24 for genotype 2/3, and weeks 4, 12, 24 and 48 for non-genotype 2/3 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of Peginterferon Alfa-2b in Chinese Chronic Hepatitis C Patients
A Phase 3, Randomized, Multi-center, Active-Controlled, Open-label Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b (40kD, Y Shape) in Combination With Ribavirin in Chinese Chronic Hepatitis C Patients

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: Ypeginterferon alfa-2b
    sc, qw, 24 weeks.
  • Drug: Pegasys
    sc, qw, 24 weeks.
  • Drug: Ypeginterferon alfa-2b
    sc, qw, 48 weeks.
  • Drug: Pegasys
    sc, qw, 48 weeks.
  • Experimental: A1(Genotype2/3)
    Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 800mg/day
    Intervention: Drug: Ypeginterferon alfa-2b
  • Active Comparator: A2(Genotype 2/3)
    Pegasys 180μg/week, in combination with Ribavirin 800mg/day
    Intervention: Drug: Pegasys
  • Experimental: B1(Non-genotype 2/3)
    Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight
    Intervention: Drug: Ypeginterferon alfa-2b
  • Active Comparator: B2(Non-genotype 2/3)
    Pegasys 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight.
    Intervention: Drug: Pegasys
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
770
June 2014
April 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01581398
TB1203IFN
Yes
Xiamen Amoytop Biotech Co., Ltd.
Xiamen Amoytop Biotech Co., Ltd.
Not Provided
Principal Investigator: Wei Lai, MD, PhD Peking University People's Hospital
Xiamen Amoytop Biotech Co., Ltd.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP