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The SIM-SOF Trial for Hepatitis C

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pegylated Interferon alfa-2b
Simeprevir
Ribavirin
Sofosbuvir
Sponsored by
Center For Hepatitis C, Atlanta, GA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Hepatitis C

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard

Simeprevir + Sofosbuvir

Arm Description

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

(SIM-SOF) which is Simeprevir + Sofosbuvir for 12 weeks

Outcomes

Primary Outcome Measures

Proportion of Participants With Sustained Virologic Response 12 (SVR-12)
Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy

Secondary Outcome Measures

Serum HCV RNA Level

Full Information

First Posted
June 17, 2014
Last Updated
March 11, 2016
Sponsor
Center For Hepatitis C, Atlanta, GA
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1. Study Identification

Unique Protocol Identification Number
NCT02168361
Brief Title
The SIM-SOF Trial for Hepatitis C
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center For Hepatitis C, Atlanta, GA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
Active Comparator
Arm Description
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
Arm Title
Simeprevir + Sofosbuvir
Arm Type
Experimental
Arm Description
(SIM-SOF) which is Simeprevir + Sofosbuvir for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Pegylated Interferon alfa-2b
Other Intervention Name(s)
Pegintron
Intervention Description
1.5 ugm/kg/week subcutaneously injected along with ribavirin and sofosbuvir for 12 weeks total
Intervention Type
Drug
Intervention Name(s)
Simeprevir
Other Intervention Name(s)
Olysio
Intervention Description
150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Ribavirin Ribasphere Ribapak
Intervention Description
1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir
Other Intervention Name(s)
Sovaldi
Intervention Description
12 weeks of combination sofosbuvir and simeprevir
Primary Outcome Measure Information:
Title
Proportion of Participants With Sustained Virologic Response 12 (SVR-12)
Description
Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy
Time Frame
12 weeks post-therapy
Secondary Outcome Measure Information:
Title
Serum HCV RNA Level
Time Frame
4 and 12 weeks into therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian L Pearlman, MD
Organizational Affiliation
Center for Hepatitis C
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Hepatitis C
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25557952
Citation
Pearlman BL, Ehleben C, Perrys M. The combination of simeprevir and sofosbuvir is more effective than that of peginterferon, ribavirin, and sofosbuvir for patients with hepatitis C-related Child's class A cirrhosis. Gastroenterology. 2015 Apr;148(4):762-70.e2; quiz e11-2. doi: 10.1053/j.gastro.2014.12.027. Epub 2014 Dec 31.
Results Reference
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The SIM-SOF Trial for Hepatitis C

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