The SIM-SOF Trial for Hepatitis C

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Center For Hepatitis C, Atlanta, GA
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2b; Ribavirin; Simeprevir; Sofosbuvir

Criteria

Inclusion Criteria:

• chronic hepatitis c,

• cirrhosis biopsy-proven, or via fibrotest,

• CPT score less than 7,

• genotype 1a,

• INR 2.3 or less,

• serum albumin greater than 2.7 gm/dL,

• total bilirubin less than 3 gm/dL,

• platelet count 50,000 per cubic milliliter or more

• GFR >50 ml/min

Exclusion Criteria:

• non genotype 1a,

• history of CPT class B or C or decompensation or history of same,

• HIV or HBV coinfection,

• prior treatment with boceprevir, telaprevir or any other direct acting antiviral agent,

• uncontrolled psychiatric or cardiopulmonary disorders,

• planning pregnancy or unwilling/unable to practice contraception