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
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 06 Nov 2021
Price :
$35
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At a glance
- Drugs Daclatasvir (Primary) ; Simeprevir (Primary) ; Sofosbuvir (Primary)
- Indications Hepatitis C
- Focus Therapeutic Use
- Acronyms IMPACT
- Sponsors Janssen Research & Development
- 15 Jun 2018 Status changed from active, no longer recruiting to completed.
- 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.