Ignite Creation Date:
2024-05-06 @ 3:46 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02371408
Status:
UNKNOWN
Last Update Posted:
2016-04-07
First Post:
2015-02-01
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:
Pharco Pharmaceuticals
Study Overview
Official Title:
A Phase IIbIIIa 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:
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