NCT01605513

Safety Study of Recombinant Interferon Variant(PEG-IFN-SA) to Treat HCV Disease

Phase I Clinical Trial of PEG-IFN-SA in HCV Disease: Evidence for Drug Safety, Tolerance, and Antiviral Activity

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether PEG-IFN-SA is safe, tolerant and effective in the treatment of HCV patients.

Detailed description

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.

Conditions

• Hepatitis C Virus

Interventions

Type	Name	Description
DRUG	interferon	PEG-IFN-SA (new interferon) was injected subcutaneously one times per week for 12 times.

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-05-25
• Last updated: 2016-01-26

Locations

1 site across 1 country: China