Chronic Hepatitus C Virus (HCV) Genotype 1 Infection MedDRA version: 18.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: JNJ-38733214-AAA (G019)
Product Code: TMC435 (or R494617)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Simeprevir
Current Sponsor code: TMC435
Other descriptive name: JNJ-3873
Sponsors
Janssen Sciences Ireland UC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants with chronic Hepatitis C Virus (HCV) genotype 1 infection between 18 to 70 years, inclusive, confirmed at screening - Participants must be treatment-naïve (that is, have not received prior treatment with any approved or investigational drug) - Participants with HCV ribonucleic acid (RNA) plasma levels greater than 10,000 international unit per milliliter (IU/ml) and lower than 6,000,000 international unit per milliliter (IU/ml) at screening - Participants with absence of cirrhosis confirmed by FibroTest/Fibrosure score less or equal to 0.75 and an aspartate aminotransferase to platelet ration index less or equal to 2 or a Fibroscan less or equal to 14.6 kilopascale (kPA), performed within 6 months prior or during the screening period Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: - Participant has infection/co-infection with HCV of a genotype other than genotype 1, human immunodeficiency virus (HIV) type 1 or 2. - Participant has any evidence of liver disease of non-HCV etiology. This includes, but is not limited to acute hepatitis A, active hepatitis B, 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-HC liver disease considered clinically significant by the investigator. - Participant with significant co-morbidities, conditions or clinical significant findings during screening assessments that in the opinion of the investigator could compromise the participants’ safety or could interfere with the Participant participating in and completing the study - Participant received an organ transplant (other than cornea or hair transplant or skin graft) - Participants have key protocol defined laboratory abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the effect of multiple-dose LDV 90 mg qd given in combination with SOF 400 mg qd on the steady-state PK of SMV 150 mg qd in chronic HCV genotype 1 infected subjects. - To evaluate the effect of multiple-dose SMV 150 mg qd on the steady-state PK of LDV 90 mg qd given in combination with SOF 400 mg qd in chronic HCV genotype 1 infected subjects.;Secondary Objective: - To evaluate the safety and tolerability of a treatment regimen containing SMV and LDV/SOF. - To evaluate the impact of the study drugs, as administered in Panels 1 and 2, on HCV RNA plasma levels and virologic response during and after treatment completion. - To assess changes from baseline in HCV NS3/4A, NS5A and NS5B sequence in subjects not achieving SVR.;Primary end point(s): 1- PK parameters (Cmin, Cmax, AUCt) at steady-state of SMV before (Day 14) and after (Day 28) the addition of LDV to the treatment regimen 2- PK parameters (Cmin, Cmax, AUCt) at steadystate of LDV before (Day 14) and after (Day 28) the addition of SMV to the treatment regimen ;Timepoint(s) of evaluation of this end point: 1- Day 14 and Day 28 2- Day 14 and Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- The percentage of patients experiencing AEs, serious adverse events (SAEs) and treatment-emergent grade 1-4 laboratory abnormalities. 2- The percentage of subjects with on-treatment virologic response. 3- The percentage of subjects with Sustained viral response 4 weeks after the actual EOT (SVR4) and SVR12 4- The percentage of subjects with on-treatment failure. 5- The percentage of subjects with viral relapse. 6- The changes from baseline in HCV NS3/4A, NS5A and NS5B sequence in subjects not achieving SVR ;Timepoint(s) of evaluation of this end point: 1- Screening up to end of follow up phase 2- Baseline up to end of treatment 3- 4 weeks after EOT and and 12 weeks after EOT 4- Baseline up to end of treatment 5- EOT (Week 12) until end of followup phase (Week 12 of follow-up phase) 6- Baseline until end of follow-up phase (Week 12 of follow-up phase) | — |
Countries
Belgium
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed