Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423800
Status:
TERMINATED
Last Update Posted:
2017-04-07
First Post:
2007-01-17
Brief Title:
Efficacy and Safety of 24 vs 48 Weeks of Pegetron Peginterferon Alfa-2b Ribavirin in Naïve Genotype 1 Hepatitis C Study P05016TERMINATED
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Efficacy and Safety of 24 vs 48 Weeks of Pegetron Peginterferon Alfa-2b Ribavirin Therapy 15 mcgkgWeek 800-1200 mgDay in Naïve Genotype 1 Hepatitis C Patients With High Baseline Viral Load Who Are HCV-RNA Negative at Week 4 and Week 12
Status:
TERMINATED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated due to difficulty in recruiting participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase IIIB randomized controlled multi-centre open-label study of 24 versus 48 weeks therapy with Pegetron peginterferon alfa-2b ribavirin at standard doses in naïve Hepatitis C Virus HCV genotype 1 high viral load HVL participants who are Hepatitis C Virus-Ribonucleic Acid HCV-RNA negative at Week 4 HVL will be defined as HCV-RNA of 600000 IUmL prior to the initiation of therapy Participants with genotype 1 baseline HVL prescribed Pegetron peginterferon and ribavirin in the usual manner in accordance with the marketing authorization and who are viral negative at Week 4 will be randomized at Week 8 to receive a total of 24 or 48 weeks of therapy Participants will be required to have their baseline and Week-12 viral load analyzed by the same local laboratory using the standard of care test used by the site Qualitative testing at Week 4 8 16-20 24 and 48 may be conducted either by local laboratory or a central laboratory identified by the sponsor using an assay specified by the sponsor No additional interventions outside of the clinics standard of care and the conditions of the Canadian product monograph for Pegetron will be applied to participants
Detailed Description:
None
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