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
1 other identifier
interventional
770
1 country
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2012
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedFirst Posted
Study publicly available on registry
April 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedOctober 7, 2014
April 1, 2012
2 years
February 16, 2012
October 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (4)
A1(Genotype2/3)
EXPERIMENTALYpeginterferon alfa-2b 180μg/week, in combination with Ribavirin 800mg/day
A2(Genotype 2/3)
ACTIVE COMPARATORPegasys 180μg/week, in combination with Ribavirin 800mg/day
B1(Non-genotype 2/3)
EXPERIMENTALYpeginterferon alfa-2b 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight
B2(Non-genotype 2/3)
ACTIVE COMPARATORPegasys 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight.
Interventions
Eligibility Criteria
You may qualify if:
- \~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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Southwest Hospital
Chongqing, China
Fuzhou Infectious Disease Hospital
Fuzhou, China
Guangzhou Eighth People's Hospital
Guangzhou, China
Nanfang Hospital
Guangzhou, China
Third Affiliated Hospital of Sun Yat-sen University
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
Renji Hospital
Shanghai, China
Ruijing Hospital
Shanghai, China
Shanghai Public Health Clinical Center
Shanghai, 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 Xinjiang Medical University
Ürümqi, 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
Tangdu Hospital, Fourth Military Medical University
Xi'an, China
Xijing Hospital
Xi'an, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Hennan Provincial People's Hospital
Zhengzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Lai, MD, PhD
Peking University People's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2012
First Posted
April 20, 2012
Study Start
April 1, 2012
Primary Completion
April 1, 2014
Study Completion
June 1, 2014
Last Updated
October 7, 2014
Record last verified: 2012-04