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The SIM-SOF Trial for Hepatitis C

NCT02168361 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2016-03-14

Study results available
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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.

Conditions

  • Chronic Hepatitis C

Interventions

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

Sponsors & Collaborators

  • Center For Hepatitis C, Atlanta, GA

    lead OTHER

Principal Investigators

  • Brian L Pearlman, MD · Center for Hepatitis C

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-12-31
Completion
2015-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02168361 on ClinicalTrials.gov