Phase 2
Completed N=35
A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients With Recurrent Chronic Hepatitis C Genotype 1b Infection After Orthotopic Liver Transplantation
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01938625 ↗
Enrolled (actual)
35
Serious AEs
22.9%
Results posted
Nov 2018
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After the End of Treatment (SVR 12) — 100; 88 percentage of participants
Summary
The purpose of the study is to evaluate effect of steady-state (when the amount of drug administered (in a given time period is equal to the amount of drug eliminated in that same period) of simeprevir and daclatasvir on the steady-state pharmacokinetics (what a medication does to the body) of cyclosporine (applicable to Part 1 only) and tacrolimus when administered as a combinational regimen in post-orthotopic liver transplantation (OLT) participants with recurrent hepatitis C virus (HCV) genotype 1b infection and effectiveness of a 24-week treatment regimen containing simeprevir, daclatasvir, and ribavirin (RBV) with respect to the proportion of HCV genotype 1b infected post-OLT participants achieving sustained virologic response 12 weeks after end of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After the End of Treatment (SVR 12) |
100; 88 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 4 Weeks After the End of Treatment (SVR 4) |
100; 88 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 24 Weeks After the End of Treatment (SVR 24) |
100; 88 | — |
| SECONDARY Percentage of Participants With HCV RNA (< 25 IU/mL Undetectable) and HCV RNA < 25 IU/mL Detectable |
30; 36; 10; 12; 30; 24 | — |
| SECONDARY Percentage of Participants With HCV RNA (<) 100 IU/mL at Week 4 |
100; 100 | — |
| SECONDARY Number of Participants With On-Treatment Failure |
0; 3 | — |
| SECONDARY Number of Participants With Viral Breakthrough |
0; 3 | — |
| SECONDARY Number of Participants With Viral Relapse |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Liver transplant between 6 months and 10 years prior to the screening visit
- Hepatitis C virus (HCV) genotype 1 subtype b infection confirmed at screening
- Screening HCV ribonucleic acid level greater than 10,000 IU/mL
- HCV treatment-naïve participants must not have received post orthotopic liver transplant treatment with any approved or investigational drug for the treatment of HCV
- Receiving stable immunosuppressant therapy (ie, no change in dose in the last month) with cyclosporine (only allowed in Part 1) or tacrolimus for more than 3 months prior to the screening visit
Exclusion Criteria
- Evidence of acute or chronic hepatic decompensation after the liver transplantation (including ascites, bleeding varices or hepatic encephalopathy)
- Any liver disease of non-HCV etiology, including current evidence of graft rejection except the presence of liver steatosis
- Any other clinically significant disease that in the opinion of the investigator would be exacerbated by the known effects of ribavirin
- Coinfection with HCV of another genotype than genotype 1b, HIV type 1 or 2 (positive HIV-1 or HIV-2 antibodies test at screening), and hepatitis B virus (hepatitis B surface antigen positive)
- Multi-organ transplant that included heart, lung, pancreas, or kidney
Data sourced from ClinicalTrials.gov (NCT01938625). 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.