Phase 2, Open-Label Study to Investigate the Pharmacokinetics, Efficacy, Safety, and Tolerability of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052) and Ribavirin (RBV) in Subjects With Recurrent Chronic Hepatitis C Genotype 1b Infection After Orthotopic Liver Transplantation
Phase of Trial: Phase II
Latest Information Update: 15 Feb 2018
At a glance
- Drugs Daclatasvir (Primary) ; Simeprevir (Primary) ; Ribavirin
- Indications Hepatitis C
- Focus Pharmacokinetics; Therapeutic Use
- Acronyms SATURN
- Sponsors Janssen R&D Ireland
- 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.
- 24 Sep 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov
- 08 Apr 2015 Results will be presented at The International Liver Congress 2015 of the European Association for the Study of the Liver (EASL), as per Janssen Sciences media release.