Status:
COMPLETED
Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection
Lead Sponsor:
Peter J. Ruane, M.D.
Collaborating Sponsors:
Janssen Scientific Affairs, LLC
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 Sof...
Eligibility Criteria
Inclusion
- HCV genotype 4 infection
- HCV RNA \>10,000 IU/mL at screening.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02253550
Start Date
October 1 2014
End Date
January 1 2016
Last Update
February 24 2016
Active Locations (1)
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1
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States, 90036