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

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581398
• Other study ID #: TB1203IFN
• Status: Completed
• Phase: Phase 3
• First received: February 16, 2012
• Last updated: October 6, 2014
• Start date: April 2012
• Est. completion date: June 2014

Study information

• Verified date: April 2012
• Source: Xiamen Amoytop Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 770
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Ypeginterferon alfa-2b
sc, qw, 24 weeks.
• Pegasys
sc, qw, 24 weeks.
• Ypeginterferon alfa-2b
sc, qw, 48 weeks.
• Pegasys
sc, qw, 48 weeks.

Locations

Country	Name	City	State
China	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	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

Sponsors (1)

Lead Sponsor	Collaborator
Xiamen Amoytop Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No