Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00493805
Status:
TERMINATED
Last Update Posted:
2017-04-07
First Post:
2007-06-25
Brief Title:
Study of Response in Chronic Hepatitis C CHC Participants Genotype 1 With Insulin Resistance and Prolonged Treatment Duration in Late Responders P04823MK-4031-303
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Study to Evaluate Response Rates in Chronic Hepatitis C CHC Patients Genotype 1 With Insulin Resistance and to Assess Prolonged Treatment Duration in Late Virological Responders
Status:
TERMINATED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow Enrollment
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 3b4 prospective open-label randomized multicenter study of peginterferon alfa-2b plus ribavirin in participants with chronic hepatitis C genotype 1 The study consists of two parts 1 a noninterventional arm HOMA IR 2 and 2 an interventional arm HOMA IR 2 where HOMA IR is the insulin resistance index for the participants calculated by fasting insulin uUmL x fasting glucose mmolL225 Participants in the noninterventional arm are treated according to the European labeling and response rates are evaluated at Month 1 optional 3 6 12 and follow up Participants in the interventional arm are treated with PEG-Intron 15 ugkg subcutaneous once weekly plus weight-based REBETOL 800-1400 mg oral capsules daily for a variable period depending on their response at Week 12 1 HCV-RNA positive with 2-log drop in viral load treatment will be discontinued 2 HCV-RNA positive with 2-log drop in viral load participants will be randomized 11 to Group A stop treatment at Week 48 or Group B stop treatment at Week 72 and 3 HCV-RNA negative treatment will be changed to be according to the European labeling and response rates will be evaluated at Month 6 12 and follow up All participants will go on with their treatment after Week 12 until the results of the HCV polymerase chain reaction PCR are available maximum of 4 weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT number2006-000757-21 | None | None | None |