Ignite Creation Date:
2024-05-06 @ 12:18 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01542788
Status:
COMPLETED
Last Update Posted:
2014-05-19
First Post:
2012-02-17
Brief Title:
Sofosbuvir Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant Interferon Ineligible or Unwilling to Take Interferon
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Double-Blind Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977 Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 HCV Infection Who Are Interferon Intolerant Interferon Ineligible or Unwilling to Take Interferon
Status:
COMPLETED
Status Verified Date:
2014-05
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:
POSITRON
Brief Summary:
This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection who were interferon IFN ineligible IFN intolerant or unwilling to take IFN Participants were randomized in a 31 ratio to receive sofosbuvir SOFribavirin RBV or placebo to match SOFplacebo to match RBV Randomization was stratified by presenceabsence of cirrhosis Approximately 20 of participants may have had evidence of cirrhosis at screening
Detailed Description:
Participants who were randomized to the placebo arm and completed all scheduled study procedures were eligible to receive active SOFRBV in open-label Study GS-US-334-0109
Participants who do not achieve sustained virologic response SVR were eligible for enrollment in the Sequence Registry Study GS-US-248-0123 The purpose of the Sequence Registry Study is to monitor the persistence of resistant mutations for up to 3 years
Participants who achieved SVR were eligible for enrollment in the SVR Registry Study GS-US-248-0122 The purpose of the SVR Registry Study is to evaluate durability of SVR for up to 3 years after treatment
Participants who do not achieve sustained virologic response SVR were eligible for enrollment in the Sequence Registry Study GS-US-248-0123 The purpose of the Sequence Registry Study is to monitor the persistence of resistant mutations for up to 3 years
Participants who achieved SVR were eligible for enrollment in the SVR Registry Study GS-US-248-0122 The purpose of the SVR Registry Study is to evaluate durability of SVR for up to 3 years after treatment
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