Hepatitis C Virus (HCV) genotype-1b and 4 Infection MedDRA version: 17.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: JNJ-38733214-AAA - capsule, hard (G019) - 150mg
Product Code: TMC435 (or R494617)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Simeprevir
Current Sponsor code: TMC435
Other de
Sponsors
Janssen R&D Ireland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Man or woman, between 18 and 70 years of age, inclusive, at screening - Hepatitis C Virus (HCV genotype): HCV genotype 1b or 4 (determined at screening) - Plasma HCV RNA: Greater than (>) 10,000 international unit per milliliter (IU/mL) (determined at screening) - HCV disease status: FibroScan less than (12.5 kPa, absence of findings suspicious for hepatocellular carcinoma documented by an abdominal ultrasound, performed within 3 months prior to screening, or between screening and baseline (Day 1) - HCV treatment history: HCV treatment-naive participants, defined as never having received HCV treatment with any approved or investigational drug (including vaccines); OR HCV treatment-experienced, defined as having received previous HCV treatment with any (pegylated) interferon ([Peg]IFN)-based drug regimen (with or without ribavirin [RBV] and not including a direct-acting antiviral agent [DAA]). Last dose in this previous HCV treatment course should have occurred at least 2 months prior to screening 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: - Infection/co-infection: HCV genotype other than 1b or 4, Human immunodeficiency virus type 1 or 2 - Liver disease of non-HCV etiology: Any evidence of liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A, hepatitis B (hepatitis B surface antigen positive), 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 - Hepatic decompensation: History or evidence of clinical hepatic decompensation (presence of ascites, bleeding varices or hepatic encephalopathy) - Organ transplantation/renal replacement therapy: Prior organ transplant (other than cornea, hair transplant or skin graft), except for history of kidney transplant with subsequent renal failure requiring hemodialysis and for which use of immunosuppressants has been discontinued; Considered for kidney transplant or imminent renal replacement therapy (including intermittent hemodialysis; continuous hemofiltration and hemodialysis; and peritoneal dialysis) for participants with severe renal impairment within a time frame that overlaps with study participation - Key protocol defined laboratory abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate safety and tolerability of a 12-week treatment regimen containing SMV and DCV. To evaluate on-treatment virologic response of a 12-week treatment regimen containing SMV and DCV. To evaluate the efficacy (SVR4 and SVR24) of a 12-week treatment regimen containing SMV and DCV. To evaluate the frequency of on-treatment failure during a 12-week treatment regimen containing SMV and DCV. To evaluate the frequency of viral relapse after a 12-week treatment regimen containing SMV and DCV. To assess changes from baseline in the HCV NS3/4A and NS5A sequence in subjects not achieving SVR. To evaluate plasma PK of SMV in subjects with severe renal impairment or ESRD on hemodialysis using a population PK modeling approach. Additional secondary objectives are listed in the protocol;Primary end point(s): Percentage of Participants With Sustained Virologic Response at Week 12 After End of Treatment (SVR12);Timepoint(s) of evaluation of this end point: 12 weeks after end of treatment (EOT) (Week 12 of follow-up phase);Main Objective: The primary objective is to evaluate the efficacy (SVR12) of a 12-week treatment regimen containing SMV and DCV in subjects with chronic HCV genotype 1b or 4 infection and either severe renal impairment or ESRD on hemodialysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 - Percentage of Participants With On-treatment Response 2 - Percentage of Participants With Sustained Virologic Response at Week 4 After End of Treatment (SVR4) 3 - Percentage of Participants With Sustained Virologic Response at Week 24 After End of Treatment (SVR24) 4 - Percentage of Participants With on-treatment Failure 5 - Percentage of Participants With Viral Relapse 6 - Change From Baseline in Hepatitis C Virus (HCV) Nonstructural Protein 3/4A (NS3/4A) and Nonstructural Protein 5A (NS5A) Sequence in Participants not Achieving SVR 7 - Change From Baseline in HCV Symptom and Impact Questionnaire version 4 (HCVSIQv4) Overall Body Symptom score;Timepoint(s) of evaluation of this end point: 1 - Baseline up to EOT (Week 12) 2 - 4 weeks after EOT (Week 4 of follow-up phase) 3 - 24 weeks after EOT (Week 24 of follow-up phase) 4 - Baseline up to EOT (Week 12), 12 weeks after EOT (Week 12 of follow-up phase) 5 - EOT (Week 12) until end of followup phase (Week 24 of follow-up phase) 6 - Baseline until end of follow-up phase (Week 24 of follow-up phase) 7 - Baseline until end of follow-up phase (Week 24 of follow-up phase) | — |
Countries
Spain
Contacts
Public ContactGlobal Clinical Operations
Janssen-Cilag S.A
Outcome results
None listed