Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Peking University People's Hospital
Information provided by (Responsible Party):
Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01140997
First received: June 8, 2010
Last updated: January 31, 2013
Last verified: June 2010
History of Changes

June 8, 2010
January 31, 2013
July 2010
January 2011   (final data collection date for primary outcome measure)
Efficacy [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
Proportion of patients with HCV RNA undetectable at week 12.
Efficacy [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
The propotion of patients with HCV RNA undetectable at week 12 of treatment.
Complete list of historical versions of study NCT01140997 on ClinicalTrials.gov Archive Site
Efficacy [ Time Frame: Week 4, 12, 24, 48 and 72 ] [ Designated as safety issue: Yes ]
  1. Proportion of patients with HCV RNA undetectable at Week 4, 24,48 and 72;
  2. Average decline level of log10 of HCV RNA at Week 4, 12, 24, 48 and 72.
Efficacy [ Time Frame: Week 4, 12, 24 and 48 from treatment start; week 24 after treatment ] [ Designated as safety issue: Yes ]
  1. The proportion of patients with HCV RNA undetectable at Week 4, 24 and 48 from treatment start and week 24 after treatment;
  2. The average decline log10 of HCV RNA at Week 4, 12, 24 and 48 from treatment start and week 24 after treatment.
Not Provided
Not Provided
 
Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C
A Multi-center, Randomized, Open-label and Positive Controlled Phase II Clinical Trial to Assess Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C.

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.
Not Provided
Interventional
Phase 2
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, for 48 weeks.
    Other Name: Peginterferon alfa-2b
  • Drug: Peginterferon alfa-2a
    sc, qw, for 48 weeks.
    Other Name: Pegasys
  • Experimental: Group 1
    Ypeginterferon alfa-2b 90mcg per Week, with Ribavirin 1000-1200mg/d
    Intervention: Drug: Ypeginterferon alfa-2b
  • Experimental: Group 2
    Ypeginterferon alfa-2b 135mcg per Week, with Ribavirin 1000-1200mg/d
    Intervention: Drug: Ypeginterferon alfa-2b
  • Experimental: Group 3
    Ypeginterferon alfa-2b 180mcg per Week, with Ribavirin 1000-1200mg/d
    Intervention: Drug: Ypeginterferon alfa-2b
  • Active Comparator: Group 4
    Pegasys 180mcg per Week, with Ribavirin 1000-1200mg/d
    Intervention: Drug: Peginterferon alfa-2a
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
211
March 2012
January 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01140997
TB1006IFN
Yes
Xiamen Amoytop Biotech Co., Ltd.
Xiamen Amoytop Biotech Co., Ltd.
Peking University People's Hospital
Principal Investigator: Wei Lai, MD, PhD Peking University People's Hospital
Xiamen Amoytop Biotech Co., Ltd.
June 2010

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