A Phase 2 Open-label Study to Investigate the Efficacy, Safety and Pharmacokinetics of 12 Weeks of Treatment With Simeprevir, Daclatasvir and Sofosbuvir, Followed by a 5-Year Post-treatment Long-term Follow-up, in Treatment-naive and Treatment-experienced Subjects With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease

Trial Profile

A Phase 2 Open-label Study to Investigate the Efficacy, Safety and Pharmacokinetics of 12 Weeks of Treatment With Simeprevir, Daclatasvir and Sofosbuvir, Followed by a 5-Year Post-treatment Long-term Follow-up, in Treatment-naive and Treatment-experienced Subjects With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 09 May 2017

At a glance

  • Drugs Daclatasvir (Primary) ; Simeprevir (Primary) ; Sofosbuvir
  • Indications Hepatitis C
  • Focus Therapeutic Use
  • Acronyms IMPACT
  • Sponsors Janssen Research & Development
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 09 May 2017 Results (n=521) of IMPACT,OPTIMIST-1,OPTIMIST-2 and ACCORDION studies presented at the Digestive Disease Week 2017.
    • 01 Mar 2017 Planned End Date changed from 1 Jan 2020 to 1 Dec 2019.
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