Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2026-01-03 @ 8:40 PM
Study NCT ID:
NCT02168361
Status:
COMPLETED
Last Update Posted:
2016-03-14
First Post:
2014-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The SIM-SOF Trial for Hepatitis C
Sponsor:
Center For Hepatitis C, Atlanta, GA
Organization:
Study Overview
Official Title:
The SIM-SOF Trial: A Randomized Trial Comparing Simeprevir-Sofosbuvir Versus Peginterferon/Ribavirin/Sofosbuvir for the Treatment of Chronic Hepatitis C Genotype-1a-infected Patients With Cirrhosis
Status:
COMPLETED
Status Verified Date:
2016-03
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:
Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label combination of simeprevir+ sofosbuvir without Ribavirin.
Detailed Description:
Patients can be treatment naive or prior null response to Peg/RBV, and must be genotype subtype 1a.
Must have Child's Class A cirrhosis/compensated and no history of decompensation
Must have Child's Class A cirrhosis/compensated and no history of decompensation
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?: