The SIM-SOF Trial for Hepatitis C

March 11, 2016 updated by: Center For Hepatitis C, Atlanta, GA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Center for Hepatitis C

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard
Pegylated Interferon Alfa-2b (1.5 ugm/kg/week subcutaneously) plus ribavirin (1000-1200 mg daily orally) plus sofosbuvir (400 mg daily) for 12 weeks
Drug: Pegylated Interferon alfa-2b
1.5 ugm/kg/week subcutaneously injected along with ribavirin and sofosbuvir for 12 weeks total
Other Names:
  • Pegintron
Drug: Ribavirin
1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir
Other Names:
  • Ribavirin Ribasphere Ribapak
Drug: Sofosbuvir
12 weeks of combination sofosbuvir and simeprevir
Other Names:
  • Sovaldi
EXPERIMENTAL: Simeprevir + Sofosbuvir
(SIM-SOF) which is Simeprevir + Sofosbuvir for 12 weeks
Drug: Sofosbuvir
12 weeks of combination sofosbuvir and simeprevir
Other Names:
  • Sovaldi
Drug: Simeprevir
150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks
Other Names:
  • Olysio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With Sustained Virologic Response 12 (SVR-12)
Time Frame: 12 weeks post-therapy
Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy
12 weeks post-therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum HCV RNA Level
Time Frame: 4 and 12 weeks into therapy
4 and 12 weeks into therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center For Hepatitis C, Atlanta, GA

Investigators

  • Principal Investigator: Brian L Pearlman, MD, Center for Hepatitis C

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

June 17, 2014

First Submitted That Met QC Criteria

June 19, 2014

First Posted (ESTIMATE)

June 20, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 14, 2016

Last Update Submitted That Met QC Criteria

March 11, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHC-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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