Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT01573351
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2012-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
Official Title:
A Phase 3, Open-Label Study With Asunaprevir and Daclatasvir Plus Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) (P/R) (QUAD) for Subjects Who Are Null or Partial Responders to Peginterferon Alfa 2a or 2b Plus Ribavirin With Chronic Hepatitis C Genotypes 1 or 4 Infection
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:
Hallmark QUAD
Brief Summary:
The purpose of this study is to assess efficacy, as determined by the proportion of subjects with Sustained Virologic Response at Post-Treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) \< Limit of quantitation (LOQ) at post-treatment Week 12.
Detailed Description:
* ASV = Asunaprevir (BMS-650032)
* DCV = Daclatasvir (BMS-790052)
* Peg = Peg-interferon Alfa-2a (PegIFN)
* Rib = Ribavirin (RBV)
* DCV = Daclatasvir (BMS-790052)
* Peg = Peg-interferon Alfa-2a (PegIFN)
* Rib = Ribavirin (RBV)
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-005422-21 | EUDRACT_NUMBER | None | View |