Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C (PEGIFN)
This study has been completed.
Sponsor:
Xiamen Amoytop Biotech Co., Ltd.
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
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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 ]
- Proportion of patients with HCV RNA undetectable at Week 4, 24,48 and 72;
- 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
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
| 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 Hepatitis A Hepatitis, Chronic 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 May 22, 2013