Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-03-03 @ 5:04 PM
Study NCT ID:
NCT02371408
Status:
UNKNOWN
Last Update Posted:
2016-04-07
First Post:
2015-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Efficacy and Safety of PPI-668 (NS5A Inhibitor) Plus Sofosbuvir, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype-4
Sponsor:
Pharco Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase IIb/IIIa, Randomized Study to Evaluate the Efficacy and Safety of PPI-668 (NS5A Inhibitor) Plus Sofosbuvir, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype-4
Status:
UNKNOWN
Status Verified Date:
2015-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 study will assess the efficacy of PPI-668 (USAN: ravidasvir hydrochloride) in combination with sofosbuvir, with or without ribavirin, in the following Egyptian HCV gt-4 patient populations:
1. Treatment-naïve patients, with and without cirrhosis (Group 1)
2. Previous non-responders to interferon-based therapies, without cirrhosis (Group 2)
3. Previous non-responders to interferon-based therapies, with cirrhosis (Group 3)
1. Treatment-naïve patients, with and without cirrhosis (Group 1)
2. Previous non-responders to interferon-based therapies, without cirrhosis (Group 2)
3. Previous non-responders to interferon-based therapies, with cirrhosis (Group 3)
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?: