The SIM-SOF Trial for Hepatitis C

Completed · Phase 4

Conditions studied: Chronic Hepatitis C

In brief

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.

Key facts

Study ID

NCT02168361

Run by

Center For Hepatitis C, Atlanta, GA

People needed

93

Starts

2013-12-01

Expected to finish

2015-04-01

Last updated by the study team

2016-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Center for Hepatitis C — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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