Status:
COMPLETED
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection
Lead Sponsor:
Janssen R&D Ireland
Conditions:
Chronic Hepatitis C
Genotype 4 Chronic Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to show superiority of simeprevir (SMV) in combination with sofosbuvir for 12 weeks versus a historical control. Historical control will be a composite of the observed his...
Detailed Description
This is a Phase 3, open-label (all people know the identity of the intervention), single-arm, multicenter study (conducted at multiple sites). The study consists of 3 periods: a Screening period (up t...
Eligibility Criteria
Inclusion
- Subjects with confirmed hepatitis C virus (HCV) with HCV RNA greater than (\>) 10000 international unit per milliliter (IU/mL)
- Subjects who are treatment naive or treatment-experienced.
- Subjects must have documentation of a liver biopsy or fibroscan or agree to have one during screening
- Subjects with cirrhosis must have an hepatic imaging procedure (ultrasound, CT scan or magnetic resonance imaging \[MRI\]) within 6 months before the screening visit (or during the screening period) with no findings suspicious for hepatocellular carcinoma (HCC)
- Women of childbearing potential or men with a female partner of childbearing potential must agree to use an effective form of contraception, or not be heterosexually active, or of nonchildbearing potential
Exclusion
- Evidence of clinical hepatic decompensation
- Any liver disease of non-HCV etiology
- Subjects with a past history of treatment with an approved or investigational DAA
- 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)
- Infection/co-infection with HCV non-genotype 4
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02250807
Start Date
January 1 2015
End Date
December 1 2015
Last Update
November 17 2016
Active Locations (6)
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1
Badalona, Spain
2
Barcelona, Spain
3
Madrid, Spain
4
Santander, Spain