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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
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Drug: Ypeginterferon alfa-2b
Drug: Pegasys
Phase 3

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 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 770
Study Start Date: April 2012
Study Completion Date: June 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1(Genotype2/3)
Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 800mg/day
Drug: Ypeginterferon alfa-2b
sc, qw, 24 weeks.
Active Comparator: A2(Genotype 2/3)
Pegasys 180μg/week, in combination with Ribavirin 800mg/day
Drug: Pegasys
sc, qw, 24 weeks.
Experimental: B1(Non-genotype 2/3)
Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight
Drug: Ypeginterferon alfa-2b
sc, qw, 48 weeks.
Active Comparator: B2(Non-genotype 2/3)
Pegasys 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight.
Drug: Pegasys
sc, qw, 48 weeks.

  Eligibility

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

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)
  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: NCT01581398

Locations
China
Peking University People's Hospital
Beijing, China
Beijing Youan Hospital, Capital Medical University
Beijing, China
Beijing Youyi Hospital, capital Medical University
Beijing, China
302 Military Hospital
Beijing, China
Peking University First 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
Southwest Hospital
Chongqing, China
Fuzhou Infectious Disease Hospital
Fuzhou, China
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
Nanfang Hospital
Guangzhou, China
Guangzhou Eighth People's Hospital
Guangzhou, China
First Affiliated Hospital of Guangxi Medical University
Guilin, China
Affiliated Hospital of Guiyang Medical College
Guiyang, China
First Affiliated Hospital, Zhejiang University
Hangzhou, 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
85 Militay Hospital
Shanghai, China
Huashan Hospital
Shanghai, China
Shanghai Public Health Clinical Center
Shanghai, China
Ruijing Hospital
Shanghai, China
Renji Hospital
Shanghai, China
Third Affiliated Hospital, Hebei Medical University
Shijiazhuang, China
First Affiliated Hospital, Shanxi University
Taiyuan, China
Tianjin Third Central Hospital
Tianjin, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
First Affiliated Hospital of Xinjiang Medical University
Wulumuqi, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Tangdu Hospital, Fourth Military Medical University
Xian, China
Xijing Hospital
Xian, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Hennan Provincial People's Hospital
Zhengzhou, China
Sponsors and Collaborators
Xiamen Amoytop Biotech Co., Ltd.
Investigators
Principal Investigator: Wei Lai, MD, PhD Peking University People's Hospital
  More Information

No publications provided

Responsible Party: Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT01581398     History of Changes
Other Study ID Numbers: TB1203IFN
Study First Received: February 16, 2012
Last Updated: October 6, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Xiamen Amoytop Biotech Co., Ltd.:
Peginterferon
Pegasys
Sustained virus response
HCV

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

ClinicalTrials.gov processed this record on November 25, 2014