Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2026-02-28 @ 8:48 PM
Study NCT ID:
NCT01858961
Status:
WITHDRAWN
Last Update Posted:
2014-01-23
First Post:
2013-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label Trial to Compare BI 207127 to Telaprevir in HCV Patients
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
A Phase III, Randomised, Open Label, Active-controlled Study of an Interferon-free Regimen of BI 207127 in Combination With Faldaprevir and Ribavirin Compared to Telaprevir in Combination With Pegylated interferon-a and Ribavirin in Treatment-naive Patients With Chronic Genotype 1b Hepatitis C Virus Infection
Status:
WITHDRAWN
Status Verified Date:
2014-01
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 aim of this trial is to evaluate efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD Faldaprevir and RBV compared to a Telaprevir-based regimen along with PegIFN and RBV in chronically infected HCV GT1 treatment naïve patients, including patients with compensated cirrhosis.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-004544-30 | EUDRACT_NUMBER | EudraCT | View |