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
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Drug: Ypeginterferon alfa-2b
Drug: Peginterferon alfa-2a
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Xiamen Amoytop Biotech Co., Ltd.:

Primary Outcome Measures:
  • Efficacy [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
    Proportion of patients with HCV RNA undetectable at week 12.


Secondary Outcome Measures:
  • 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.


Enrollment: 211
Study Start Date: July 2010
Study Completion Date: March 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Ypeginterferon alfa-2b 90mcg per Week, with Ribavirin 1000-1200mg/d
Drug: Ypeginterferon alfa-2b
sc, qw, for 48 weeks.
Other Name: Peginterferon alfa-2b
Experimental: Group 2
Ypeginterferon alfa-2b 135mcg per Week, with Ribavirin 1000-1200mg/d
Drug: Ypeginterferon alfa-2b
sc, qw, for 48 weeks.
Other Name: Peginterferon alfa-2b
Experimental: Group 3
Ypeginterferon alfa-2b 180mcg per Week, with Ribavirin 1000-1200mg/d
Drug: Ypeginterferon alfa-2b
sc, qw, for 48 weeks.
Other Name: Peginterferon alfa-2b
Active Comparator: Group 4
Pegasys 180mcg per Week, with Ribavirin 1000-1200mg/d
Drug: Peginterferon alfa-2a
sc, qw, for 48 weeks.
Other Name: Pegasys

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140997

Locations
China
Peking University People's Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Beijing Youyi Hospital, Capital Medical University
Beijing, China
302 Military Hospital
Beijing, China
Beijing Youan Hospital, Capital Medical University
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
Southwest Hospital
Chongqing, China
Second Affiliated Hospital Chongqing Medical University
Chongqing, China
Fuzhou Infectious Disease Hospital
Fuzhou, China
Guangzhou Eighth People's Hospital
Guangzhou, China
Nangfang Hospital
Guangzhou, China
First Affiliated Hospital of Guangxi Medical Universtiy
Guilin, China
Second Affiliated Hospital of Harbin Medical University
Harbin, China
First Affiliated Hospital of Anhui Medical University
Hefei, China
Jinan Infectious Disease Hospital
Jinan, China
First Affiliated Hospital of Lanzhou University
Lanzhou, China
First Affiliated Hospital of Nanchang University
Nanchang, China
81 Military Hospital
Nanjing, China
Jiangsu Province Hospital
Nanjing, China
Second Hospital of Nanjing
Nanjing, China
Changhai Hospital
Shanghai, China
Shanghai Public Health Clinical Center
Shanghai, China
Renji Hospital
Shanghai, China
85 Military Hospital
Shanghai, China
Ruijin Hospital
Shanghai, China
Huashan Hospital
Shanghai, China
Shenzhen Third People's Hospital
Shenzhen, China
Third Affiliated Hospital, Hebei Medical University
Shijiazhuang, China
First Affiliated Hospital, Shanxi University
Taiyuan, China
Tianjin Third Central Hospital
Tianjin, China
First Affiliated Hospital of Wenzhou Medical College
Wenzhou, China
Tongji Hospital, Huazhong University of Science&Technology
Wuhan, China
Tangdu Hospital, Fouth Military Medical University
Xian, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Henan Provincial People's Hospital
Zhengzhou, China
Sponsors and Collaborators
Xiamen Amoytop Biotech Co., Ltd.
Peking University People's Hospital
Investigators
Principal Investigator: Wei Lai, MD, PhD Peking University People's Hospital
  More Information

No publications provided by Xiamen Amoytop Biotech Co., Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT01140997     History of Changes
Other Study ID Numbers: TB1006IFN
Study First Received: June 8, 2010
Last Updated: January 31, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Xiamen Amoytop Biotech Co., Ltd.:
HCV
CHC
Hepatitis C, Chronic
Liver Diseases
Hepatitis, Chronic
Hepatitis, Viral, Human
Hepadnaviridae Infections
Antiviral Agents
Virus Diseases
Peginterferon alfa

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Interferon-alpha
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014