Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection
Completed · Phase 2
Conditions studied: Chronic Hepatitis C
In brief
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.
Key facts
- Study ID
- NCT02253550
- Run by
- Peter J. Ruane, M.D.
- People needed
- 30
- Starts
- 2014-10-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2016-02-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- HCV genotype 4 infection
- HCV RNA >10,000 IU/mL at screening.
You may not qualify if…
- 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.
Where it is running
- Peter J. Ruane, MD, Inc. — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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