Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection
NCT ID: NCT02253550
Last Updated: 2016-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2014-10-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cirrhosis
Patients with confirmed presence of cirrhosis will received 12 weeks of treatment with Sofosbuvir and Simeprevir
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.
Sofosbuvir
Sofosbuvir is a nucleotide NS5B polymerase inhibitor developed by Gilead Sciences Inc. and approved for the treatment of chronic HCV infection.
Non-Cirrhotic
Patients with confirmed absence of cirrhosis will received 8 weeks of treatment with Sofosbuvir and Simeprevir
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.
Sofosbuvir
Sofosbuvir is a nucleotide NS5B polymerase inhibitor developed by Gilead Sciences Inc. and approved for the treatment of chronic HCV infection.
Interventions
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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.
Sofosbuvir
Sofosbuvir is a nucleotide NS5B polymerase inhibitor developed by Gilead Sciences Inc. and approved for the treatment of chronic HCV infection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCV RNA \>10,000 IU/mL at screening.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Janssen Scientific Affairs, LLC
INDUSTRY
Peter J. Ruane, M.D.
OTHER
Responsible Party
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Peter J. Ruane, M.D.
Principal Investigator, President
Principal Investigators
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Peter J Ruane, MD
Role: PRINCIPAL_INVESTIGATOR
Peter J. Ruane, MD, Inc.
Locations
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Peter J. Ruane, MD, Inc.
Los Angeles, California, United States
Countries
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Other Identifiers
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TMC435HPC2012
Identifier Type: -
Identifier Source: org_study_id
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