Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517439
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2007-08-16
Brief Title:
A Study of Hepatitis C Virus HCV Polymerase Inhibitor Pro-Drug in Combination With PEGASYS Plus COPEGUS Compared With PEGASYS Plus COPEGUS in Patients With Chronic Hepatitis C Genotype 1 Infection
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Double-blinded Study to Evaluate the Safety and Effect on Sustained Virological Response of HCV Polymerase Inhibitor Pro-drug in Combination With PEGASYS Plus Copegus Compared With the Currently Approved Combination of PEGASYS Plus Copegus in Treatment-naïve Patients With Chronic he
Status:
COMPLETED
Status Verified Date:
2016-11
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 7 arm study will determine the optimal treatment combination based on efficacy and safety Patients with chronic hepatitis C CHC genotype 1 will be randomized to one of 7 treatment groups Groups 1 2 4 5 and 6 will receive triple combination treatment with HCV polymerase inhibitor pro-drug at doses of 500 1000 or 1500mg po bid plus PEGASYS 90 or 180 micrograms sc weekly plus Copegus 1000 or 1200mg po qd for 24 weeks followed by 24 weeks of open label Standard of Care PEGASYS 180 micrograms sc weekly plus Copegus 10001200mg po qd Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 10001200mg po qd for 24 weeks after 24 weeks those achieving a rapid virological response RVR will stop all medication and non-RVR patients will remain on triple combination for an additional 24 weeks Group 7 will receive standard of care SOC for 48 weeks There will be a 24 week period of treatment-free follow-up for all treatment groups The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals
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