Chronic Hepatitis C
Conditions
Keywords
HCV, CHC, Hepatitis C, Chronic, Liver Diseases, Hepatitis, Chronic, Hepatitis, Viral, Human, Hepadnaviridae Infections, Antiviral Agents, Virus Diseases, Peginterferon alfa
Brief summary
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.
Interventions
sc, qw, for 48 weeks.
DRUGPeginterferon alfa-2a
sc, qw, for 48 weeks.
Sponsors
Peking University People's Hospital
Xiamen Amoytop Biotech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | week 12 | Proportion of patients with HCV RNA undetectable at week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | Week 4, 12, 24, 48 and 72 | 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. |
Countries
China
Outcome results
None listed