The SIM-SOF Trial for Hepatitis C
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2013 |
| End Date: | April 2015 |
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
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.
comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label
combination of simeprevir+ sofosbuvir without Ribavirin.
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
subtype 1a.
Must have Child's Class A cirrhosis/compensated and no history of decompensation
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
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