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: 14 Nov 2017
At a glance
- Drugs Daclatasvir (Primary) ; Simeprevir (Primary) ; Sofosbuvir
- Indications Hepatitis C
- Focus Therapeutic Use
- Acronyms IMPACT
- Sponsors Janssen Research & Development
- 09 Nov 2017 Planned End Date changed from 1 Dec 2019 to 6 Mar 2020.
- 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.