Safety Study of Recombinant Interferon Variant(PEG-IFN-SA) to Treat HCV Disease
The purpose of this study is to determine whether PEG-IFN-SA is safe, tolerant and effective in the treatment of HCV patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||Phase I Clinical Trial of PEG-IFN-SA in HCV Disease: Evidence for Drug Safety, Tolerance, and Antiviral Activity|
- The proportions of absence of detectable HCV RNA after the 12th treatment [ Time Frame: 12th week ] [ Designated as safety issue: No ]
- The proportions of absence of detectable HCV RNA after the 4th and 8th treatment [ Time Frame: 4th and 8th week ] [ Designated as safety issue: No ]
- HCV RNA levels after the 4th, 8th and 12th treatment [ Time Frame: the 4th, 8th and 12th week ] [ Designated as safety issue: No ]
- The test of Liver function [ Time Frame: the 2th, 4th, 6th, 8th,10th and 12th week ] [ Designated as safety issue: Yes ]Liver function test:TBIL,IBIL, ALT, AST;
- The test of Kidney function [ Time Frame: the 2th, 4th, 6th, 8th,10th and 12th week ] [ Designated as safety issue: Yes ]Kidney function test:BUN, CR;
- The test of Peripheral blood [ Time Frame: the 2th, 4th, 6th, 8th,10th and 12th week ] [ Designated as safety issue: Yes ]Peripheral blood detection:WBC, RBC, HgB,PLT, neutrophil
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||May 2012|
|Estimated Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: recombinant interferon
PEG-IFN-SA 1.0μg/kg for 12 times, Peginterferon alfa-2a 180 μg for 12 times, PEG-IFN-SA 1.5 μg/kg for 12 times, PEG-IFN-SA 2 μg/kg for 12 times, PEG-IFN-SA 3 μg/kg for 12 times, PEG-IFN-SA 1.5μg/kg + ribavirin 0.45g/bid group for 12 times, Intergen 15μg/48hours for 7 times, ribavirin 0.45g/bid for 10 times
PEG-IFN-SA (new interferon) was injected subcutaneously one times per week for 12 times.
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.
|Phase One Clinical Trial ward, First Hospital, Jilin University|
|Changchun, Jilin, China, 13021|
|Study Director:||yanhua ding, associate professor||First Hospital, Jilin University|