Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00528528
Status:
COMPLETED
Last Update Posted:
2014-06-25
First Post:
2007-09-10
Brief Title:
An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants
Sponsor:
Tibotec BVBA
Organization:
Tibotec BVBA
Study Overview
Official Title:
A Phase IIa Randomized Open-Label Study of Telaprevir VX-950 Administered Every 12 or Every 8 Hours in Combination With Either Peg-IFN alfa2a Pegasys and Ribavirin Copegus or Peg-IFN alfa2b PegIntron and Ribavirin Rebetol in Treatment-Naive Subjects With Chronic Genotype 1 Hepatitis C Infection
Status:
COMPLETED
Status Verified Date:
2014-06
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:
The purpose of this study is to explore the efficacy safety tolerability pharmacokinetics the study of the way a drug enters and leaves the blood and tissues over time and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies commercially available for chronic lasting a long time genotype 1 Hepatitis inflammation of the liver C virus HCV infection
Detailed Description:
This is a Phase 2a open-label all people know the identity of the intervention multicenter trial conducted in more than one center in participants with chronic genotype 1 HCV infection The trial consists of a Screening phase of approximately 4 weeks a treatment phase up to 48 weeks depending on participants individual virologic response and a follow-up phase of at least 24 weeks All participants will receive 12 weeks of telaprevir treatment in combination with standard therapy At Week 12 telaprevir dosing will end and participants will continue on standard therapy only Participants will be randomly assigned to receive one of the two different dosage regimens of telaprevir 750 milligram mg every 8 hours hr or 1125 mg every 12 hr in combination with standard therapy pegylated interferon Peg-IFN-alfa-2a and ribavirin RBV or Peg-IFN-alfa-2b and RBV at the standard doses Efficacy will be evaluated by HCV Ribonucleic Acid RNA values viral response viral breakthrough partial response early viral kinetics and sustained viral response Pharmacokinetics Pharmacokinetic-pharmacodynamic relationship will also be evaluated Safety will be monitored throughout the study duration
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 |
|---|---|---|---|
| 2007-001044-44 | EUDRACT_NUMBER | None | None |
| VX-950-TIDP24-C208 | None | None | None |