Phase 3
Completed N=40
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection
Chronic Hepatitis C · Genotype 4 Chronic Hepatitis C
Source: ClinicalTrials.gov NCT02250807 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12) — 100 percentage of participants
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 historical sustained virological response at Week 12 (SVR12) rates of SMV in combination with (pegylated) interferon (PegIFN)/ribavirin (RBV) of the subpopulations in study HPC3011 (NCT01567735) and will depend on the percentage of treatment-naive, prior relapser, prior non-responder, interferon (IFN)-intolerant and other subjects enrolled in this study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12) |
100 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Therapy (SVR4) |
100 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Therapy (SVR24) |
100 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) |
87.5; 40.0; 17.5; 100.0; 82.5; 40.0 | — |
| SECONDARY Percentage of Participants With On-Treatment Failure |
— | — |
| SECONDARY Percentage of Participants With Viral Breakthrough |
— | — |
| SECONDARY Percentage of Participants With Viral Relapse |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02250807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.