Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2026-02-02 @ 11:17 PM
Study NCT ID:
NCT01995266
Status:
COMPLETED
Last Update Posted:
2020-08-11
First Post:
2013-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude Dual
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
Official Title:
A Phase 3, Open-Label Study With Daclatasvir And Asunaprevir (DUAL) for Subjects With Genotype 1b Chronic Hepatitis C (HCV) Infection Who Are Intolerant or Ineligible to Interferon Alfa Therapies With or Without Ribavirin
Status:
COMPLETED
Status Verified Date:
2020-08
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:
Patients with chronic hepatitis genotype 1b, who are intolerant or ineligible to Interferon alfa therapy with or without Ribavirin, will be treated for 24 weeks with Daclatasvir (DCV) Dual regimen (= Daclatasvir + Asunaprevir) and followed for an additional 24 weeks post-treatment in order to determine the safety and efficacy of the DCV DUAL regimen
Detailed Description:
None
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?: