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Completed

NCT Number: NCT02168361

The SIM-SOF Trial for Hepatitis C

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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Fibrosis Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Center for Hepatitis C

Atlanta, Georgia, 30309, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pegylated Interferon alfa-2b

Drug

1.5 ugm/kg/week subcutaneously injected along with ribavirin and sofosbuvir for 12 weeks total

Other names: Pegintron

Simeprevir

Drug

150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks

Other names: Olysio

Ribavirin

Drug

1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir

Other names: Ribavirin Ribasphere Ribapak

Sofosbuvir

Drug

12 weeks of combination sofosbuvir and simeprevir

Other names: Sovaldi

Primary outcomes

  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 outcomes

  1. Serum HCV RNA Level

    Time frame: 4 and 12 weeks into therapy

Sponsors and collaborators

Lead sponsor

Center For Hepatitis C, Atlanta, GA

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jun 20, 2014
Registry last updated
Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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