Ignite Creation Date:
2024-05-06 @ 12:33 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01605513
Status:
COMPLETED
Last Update Posted:
2016-01-26
First Post:
2012-05-10
Brief Title:
Safety Study of Recombinant Interferon VariantPEG-IFN-SA to Treat HCV Disease
Sponsor:
The First Hospital of Jilin University
Organization:
The First Hospital of Jilin University
Study Overview
Official Title:
Phase I Clinical Trial of PEG-IFN-SA in HCV Disease Evidence for Drug Safety Tolerance and Antiviral Activity
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEG-IFN-SA
Brief 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 10μgkg Peginterferon alfa-2a 180 μg PEG-IFN-SA 15 μgkgPEG-IFN-SA 2 μgkg PEG-IFN-SA 3 μgkgPEG-IFN-SA 15μgkg ribavirin 045gbid groupIntergen 15μg48hours for 7 times and ribavirin 045gbid 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
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 10μgkg Peginterferon alfa-2a 180 μg PEG-IFN-SA 15 μgkgPEG-IFN-SA 2 μgkg PEG-IFN-SA 3 μgkgPEG-IFN-SA 15μgkg ribavirin 045gbid groupIntergen 15μg48hours for 7 times and ribavirin 045gbid 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None