NCT02168361

The SIM-SOF Trial for Hepatitis C

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Center For Hepatitis C, Atlanta, GA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Pegylated Interferon alfa-2b	1.5 ugm/kg/week subcutaneously injected along with ribavirin and sofosbuvir for 12 weeks total
DRUG	Simeprevir	150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks
DRUG	Ribavirin	1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir
DRUG	Sofosbuvir	12 weeks of combination sofosbuvir and simeprevir

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-12-01
• Completion: 2015-04-01
• First posted: 2014-06-20
• Last updated: 2016-03-14
• Results posted: 2016-03-04

Locations

1 site across 1 country: United States