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Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02253550
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : February 24, 2016
Sponsor:
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Peter J. Ruane, M.D., Peter J. Ruane, M.D., Inc.

Brief Summary:
This study will look at the safety and efficacy of 8 week and 12 week treatment with Sofosbuvir and Simeprevir in treatment-naïve and treatment-experienced patients with chronic hepatitis C genotype 4.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Simeprevir Drug: Sofosbuvir Phase 2

Detailed Description:
Patients with confirmed absence of cirrhosis will receive 8 weeks of treatment with Sofosbuvir and Simeprevir. Patients with confirmed presence of cirrhosis will receive 12 weeks of treatment with Sofosbuvir and Simeprevir. All patients will followed for 24 weeks post-treatment. Presence or absence of cirrhosis will be evaluated by FibroScan if no historical liver biopsy or FibroScan is available.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label Study to Investigate the Efficacy and Safety of an 8-Week and 12-Week Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Subjects With Chronic Genotype 4 Hepatitis C Virus Infection With and Without Cirrhosis
Study Start Date : October 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cirrhosis
Patients with confirmed presence of cirrhosis will received 12 weeks of treatment with Sofosbuvir and Simeprevir
Drug: Simeprevir
Simeprevir is a Hepatitis C Virus (HCV) NS3/4A protease inhibitor approved in the United States, Canada and Japan for the treatment of chronic HCV infection.
Other Name: Olysio; TMC435

Drug: Sofosbuvir
Sofosbuvir is a nucleotide NS5B polymerase inhibitor developed by Gilead Sciences Inc. and approved for the treatment of chronic HCV infection.
Other Name: Sovaldi; GS-7977; PSI-7977

Experimental: Non-Cirrhotic
Patients with confirmed absence of cirrhosis will received 8 weeks of treatment with Sofosbuvir and Simeprevir
Drug: Simeprevir
Simeprevir is a Hepatitis C Virus (HCV) NS3/4A protease inhibitor approved in the United States, Canada and Japan for the treatment of chronic HCV infection.
Other Name: Olysio; TMC435

Drug: Sofosbuvir
Sofosbuvir is a nucleotide NS5B polymerase inhibitor developed by Gilead Sciences Inc. and approved for the treatment of chronic HCV infection.
Other Name: Sovaldi; GS-7977; PSI-7977




Primary Outcome Measures :
  1. Sustained Virologic Response 12 Weeks after Treatment Completion (SVR12) [ Time Frame: 12 weeks post-treatment ]
    HCV RNA will be measured 12 weeks post-treatment to evaluate SVR


Secondary Outcome Measures :
  1. Sustained Virologic Response 4 and 24 Weeks after Treatment Completion [ Time Frame: 4 and 24 weeks post-treatment ]
    HCV RNA will be measured 4 and 24 weeks post-treatment to evaluate SVR



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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:

  • HCV genotype 4 infection
  • HCV RNA >10,000 IU/mL at screening.

Exclusion Criteria:

  • Evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy).
  • Any liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-HCV liver disease considered clinically significant by the investigator.
  • Infection/co-infection with HCV non-genotype 4.
  • Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening).
  • Co-infection with hepatitis-B virus (hepatitis-B-surface-antigen [HBsAg] positive).
  • Presence of significant co-morbidities or conditions that would compromise the subject's safety and could interfere with the subject's participation for the full duration of the study in the opinion of the investigator
  • Previously been treated with any direct acting anti-HCV agent (approved or investigational) for chronic HCV infection.

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): NCT02253550


Locations
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United States, California
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States, 90036
Sponsors and Collaborators
Peter J. Ruane, M.D.
Janssen Scientific Affairs, LLC
Investigators
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Principal Investigator: Peter J Ruane, MD Peter J. Ruane, MD, Inc.

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Responsible Party: Peter J. Ruane, M.D., Principal Investigator, President, Peter J. Ruane, M.D., Inc.
ClinicalTrials.gov Identifier: NCT02253550    
Other Study ID Numbers: TMC435HPC2012
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Sofosbuvir
Simeprevir
Antiviral Agents
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action