Ignite Creation Date:
2024-05-06 @ 1:49 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01903278
Status:
COMPLETED
Last Update Posted:
2015-09-25
First Post:
2013-07-17
Brief Title:
Efficacy and Safety Study of PEG-IFN-SA and Ribavirin to Treat Chronic Hepatitis C
Sponsor:
Beijing Kawin Technology Share-Holding Co Ltd
Organization:
Beijing Kawin Technology Share-Holding Co Ltd
Study Overview
Official Title:
Multi-center Randomized Open-label Parallel-group Active Controlled Study for the Efficacy and Safety of Pegylated Recombinant Consensus Interferon Variant Solution for Injection in the Treatment of Chronic Hepatitis C
Status:
COMPLETED
Status Verified Date:
2015-09
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:
None
Brief Summary:
This study is to confirm the potential effects and assess the safety of a new bio-product Pegylated Recombinant Consensus Interferon Variant Solution for Injection PEG-IFN-SA and RibavirinRBV in the treatment of Chronic hepatitis C who have not been previously treated with Interferon
Detailed Description:
Total 720 subjects are divided into two groups and treated separately according to the HCV genotypegenotype 23 and non-genotype 23 With 21 ratio between experimental group and positive-control group Peginterferon alfa-2a Pegasys plus RBV 216 subjects for genotype 23 and 504 subjects for non-genotype23 will be enrolled Accordingly PEG-IFN-SA once weekly and RBV twice a day bid are given for 24 weeks and 48 weeks respectively to the HCV genotype 23 and the HCV non-genotype 23
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