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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.

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Trial Profile

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.

Status: Withdrawn prior to enrolment
Phase of Trial: Phase II

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Daclatasvir (Primary) ; Simeprevir (Primary)
  • Indications Hepatitis C
  • Focus Therapeutic Use
  • Acronyms NEPTUNE
  • Sponsors Janssen R&D Ireland

    • Most Recent Events

    • 16 Jul 2015 Status changed from not yet recruiting to withdrawn prior to enrolment as reported by ClinicalTrials.gov
    • 18 May 2015 Planned End Date changed from 1 Feb 2016 to 1 May 2016 as reported by ClinicalTrials.gov
    • 18 May 2015 Planned initiation date changed from 1 Apr 2015 to 1 May 2015 as reported by ClinicalTrials.gov

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