An Efficacy, Safety, Tolerability and Pharmacokinetics Study of 12 Weeks Treatment With Simeprevir and Daclatasvir in Participants With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis

• Conditions: Hepatitis C Virus (HCV) genotype-1b and 4 Infection; MedDRA version: 17.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-004250-34-ES
• Lead Sponsor: Janssen R&D Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-11
• Last Update Posted: 24 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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 (<) 14.5 kilopascal (kPa), performed within 3 months prior to screening, or between screening and baseline (Day 1), and no history or signs orsymptoms of decompensated liver disease. In participants with FibroScan >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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified