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: 30 Apr 2018
At a glance
- Drugs Daclatasvir (Primary) ; Simeprevir (Primary) ; Sofosbuvir (Primary)
- Indications Hepatitis C
- Focus Therapeutic Use
- Acronyms IMPACT
- Sponsors Janssen Research & Development
- 27 Mar 2018 Planned End Date changed from 6 Mar 2020 to 5 Dec 2019.
- 18 Jan 2018 Results of pooled post-hoc analysis assessing impact of pharmacokinetic interaction between simeprevir and concomitant medications by using data from nine studies (SONET, OPTIMIST-1, OPTIMIST-2, COMMIT, GALAXY, OSIRIS, IMPACT, PLUTO and SATURN) published in the British Journal of Clinical Pharmacology.
- 09 Nov 2017 Planned End Date changed from 1 Dec 2019 to 6 Mar 2020.