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Clinical Trial Details

Trial ID: L1048
Source ID: NCT02397395
Associated Drug: Simeprevir (Smv) 150 Mg
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.
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Renal Impairment|End-stage Renal Disease
Interventions: DRUG: Simeprevir (SMV) 150 mg|DRUG: Daclatasvir (DCV) 60 mg
Outcome Measures: Primary: Percentage of Participants With Sustained Virologic Response at Week 12 After End of Treatment (SVR12), SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) lower limit of quantification (LLOQ) , detectable or undetectable at 12 weeks after EOT., 12 weeks after end of treatment (EOT) (Week 12 of follow-up phase) | Secondary: Percentage of Participants With On-treatment Response, HCV RNA results satisfying a specified threshold. The following thresholds will be considered at any time point: \<LLOQ undetectable, \<LLOQ detectable, \<LLOQ undetectable/detectable., Baseline up to EOT (Week 12)|Percentage of Participants With Sustained Virologic Response at Week 4 After End of Treatment (SVR4), SVR4 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) lower limit of quantification (LLOQ) , detectable or undetectable at 4 weeks after EOT., 4 weeks after EOT (Week 4 of follow-up phase)|Percentage of Participants With Sustained Virologic Response at Week 24 After End of Treatment (SVR24), SVR24 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) lower limit of quantification (LLOQ) , detectable or undetectable at 24 weeks after EOT., 24 weeks after EOT (Week 24 of follow-up phase)|Percentage of Participants With on-treatment Failure, Participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study treatment., Baseline up to EOT (Week 12), 12 weeks after EOT (Week 12 of follow-up phase)|Percentage of Participants With Viral Relapse, Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study treatment and confirmed HCV RNA \>=LLOQ during 24-week follow-up., EOT (Week 12) until end of follow-up phase (Week 24 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, Baseline until end of follow-up phase (Week 24 of follow-up phase)|Change From Baseline in HCV Symptom and Impact Questionnaire version 4 (HCV-SIQv4) Overall Body Symptom score, The HCV-SIQv4 is a self-administered questionnaire containing 33 items (ranging from 0=Not at All to 4=Extremely): 29 questions developed to assess the severity or frequency of symptoms associated with HCV or its treatment, 3 questions regarding the impact of symptoms on work/school attendance, and 1 question regarding the impact of symptoms on daily activities. Higher HCV-SIQv4 scores indicate worse symptom severity, more time missed from work or school, and more impairment in daily activities, respectively., Baseline until end of follow-up phase (Week 24 of follow-up phase)
Sponsor/Collaborators: Sponsor: Janssen R&D Ireland
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-05
Completion Date: 2016-05
Results First Posted:
Last Update Posted: 2015-07-17
Locations: Paris, France|Toulouse Cedex 9, France|Villejuif, France|Barcelona, Spain|Madrid, Spain|Santander, Spain
URL: https://clinicaltrials.gov/show/NCT02397395