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.

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT02397395
• Date of registration: 19/03/2015
• Prospective Registration: Yes
• Primary sponsor: Janssen R&D Ireland
• Public title: 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.
• Scientific title: A Phase 2, Open-label, Single-arm Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of 12 Weeks Treatment With Simeprevir and Daclatasvir in Subjects With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis.
• Date of first enrolment: May 2015
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02397395
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France, Spain

Contacts

• Name: Janssen R&D Ireland Clinical Trial
• Affiliation: Janssen R&D Ireland

Key inclusion & exclusion 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 (<) 14.5 kilopascal (kPa), performed within 3
months prior to screening, or between screening and baseline (Day 1), and no history
or signs or symptoms 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

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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Renal Impairment

End-stage Renal Disease

Intervention(s)

Drug: Simeprevir (SMV) 150 mg

Drug: Daclatasvir (DCV) 60 mg

Primary Outcome(s)

Percentage of Participants With Sustained Virologic Response at Week 12 After End of Treatment (SVR12) [Time Frame: 12 weeks after end of treatment (EOT) (Week 12 of follow-up phase)]

Secondary Outcome(s)

Change From Baseline in HCV Symptom and Impact Questionnaire version 4 (HCV-SIQv4) Overall Body Symptom score [Time Frame: Baseline until end of follow-up phase (Week 24 of follow-up phase)]

Percentage of Participants With on-treatment Failure [Time Frame: Baseline up to EOT (Week 12), 12 weeks after EOT (Week 12 of follow-up phase)]

Percentage of Participants With Sustained Virologic Response at Week 24 After End of Treatment (SVR24) [Time Frame: 24 weeks after EOT (Week 24 of follow-up phase)]

Percentage of Participants With Sustained Virologic Response at Week 4 After End of Treatment (SVR4) [Time Frame: 4 weeks after EOT (Week 4 of follow-up phase)]

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 [Time Frame: Baseline until end of follow-up phase (Week 24 of follow-up phase)]

Percentage of Participants With On-treatment Response [Time Frame: Baseline up to EOT (Week 12)]

Percentage of Participants With Viral Relapse [Time Frame: EOT (Week 12) until end of follow-up phase (Week 24 of follow-up phase)]

Secondary ID(s)

CR106396

2014-004250-34

TMC435HPC2018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors