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The SIM-SOF Trial for Hepatitis C

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ClinicalTrials.gov Identifier: NCT02168361
Recruitment Status : Completed
First Posted : June 20, 2014
Results First Posted : March 4, 2016
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
Center For Hepatitis C, Atlanta, GA

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Pegylated Interferon alfa-2b Drug: Simeprevir Drug: Ribavirin Drug: Sofosbuvir Phase 4

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : April 2015


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 Name: Pegintron

Drug: Ribavirin
1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir
Other Name: Ribavirin Ribasphere Ribapak

Drug: Sofosbuvir
12 weeks of combination sofosbuvir and simeprevir
Other Name: Sovaldi

Experimental: Simeprevir + Sofosbuvir
(SIM-SOF) which is Simeprevir + Sofosbuvir for 12 weeks
Drug: Simeprevir
150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks
Other Name: Olysio

Drug: Sofosbuvir
12 weeks of combination sofosbuvir and simeprevir
Other Name: Sovaldi




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Serum HCV RNA Level [ Time Frame: 4 and 12 weeks into therapy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168361


Locations
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United States, Georgia
Center for Hepatitis C
Atlanta, Georgia, United States, 30309
Sponsors and Collaborators
Center For Hepatitis C, Atlanta, GA
Investigators
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Principal Investigator: Brian L Pearlman, MD Center for Hepatitis C

Publications of Results:
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Responsible Party: Center For Hepatitis C, Atlanta, GA
ClinicalTrials.gov Identifier: NCT02168361     History of Changes
Other Study ID Numbers: CHC-21
First Posted: June 20, 2014    Key Record Dates
Results First Posted: March 4, 2016
Last Update Posted: March 14, 2016
Last Verified: March 2016

Keywords provided by Center For Hepatitis C, Atlanta, GA:
cirrhosis

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Interferon alpha-2
Ribavirin
Interferon-alpha
Sofosbuvir
Simeprevir
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors