Hepatitis C Virus Clinical Trial
Official title:
Phase I Clinical Trial of PEG-IFN-SA in HCV Disease: Evidence for Drug Safety, Tolerance, and Antiviral Activity
The purpose of this study is to determine whether PEG-IFN-SA is safe, tolerant and effective in the treatment of HCV patients.
Chronic infection with the hepatitis C virus (HCV) is a significant public health problem in
china. Progressive liver disease, as a result of chronic HCV infection, usually develops
slowly over 20-50 years and may lead to cirrhosis, hepatocellular carcinoma, liver failure
and eventual death. Symptoms are typically mild and non-specific but nevertheless can cause
a decrease in quality of life. Peginterferon alfa and ribavirin combination therapy is
currently used in the china for treatment of chronic HCV. Successful treatment is considered
to be attainment of a sustained virological response (SVR), defined as undetectable serum
HCV ribonucleic acid (RNA) 6 months after cessation of treatment.
PEG-IFN-SA is a new recombinant interferon variant. Its N-terminus is modified by 20KD
molecular weight single-methoxy polyethylene glycol (PEG). It consists of 171 amino acids
before modification. PEG-IFN-SA is reorganization, unnatural existence and a new type of
interferon (171Arg126Asp171IFN) after modification. The safety, tolerance and antiviral
activity of PEG-IFN-SA was tested in adults with HCV infection.
PEG-IFN-SA was injected subcutaneously one times per week for 12 times. Peginterferon
alfa-2a (Pegasys) is the positive control drug. 80 patients were randomly assigned to eight
groups (PEG-IFN-SA 1.0μg/kg, Peginterferon alfa-2a 180 μg, PEG-IFN-SA 1.5 μg/kg，PEG-IFN-SA 2
μg/kg， PEG-IFN-SA 3 μg/kg，PEG-IFN-SA 1.5μg/kg + ribavirin 0.45g/bid group，Intergen
15μg/48hours for 7 times and ribavirin 0.45g/bid for 10 times).
Clinical and biological adverse effects were recorded every week such as headache, nausea
and vomiting. HCV RNA level was tested by COBAS Taqman HCV Test system of Roche. Blood cell
counts were tested using an automatic cell counter such as WBC, neutrophil, PLT and HGB.
Biochemical indicators were tested by automatic biochemical analysis instrument.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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