A Phase 2, Randomized, Single-Blind, Controlled Trial of Topical Raplixa™ (Fibrin Sealant [Human]) in Intraoperative Surgical Hemostasis in a Pediatric Population
Phase of Trial: Phase II
Latest Information Update: 05 Oct 2017
At a glance
- Drugs Fibrinogen/thrombin (Primary) ; Gelatin
- Indications Surgical blood loss
- Focus Therapeutic Use
- Sponsors Mallinckrodt Inc.; ProFibrix; The Medicines Company
- 13 Jul 2017 Planned End Date changed from 1 Aug 2018 to 1 Sep 2018.
- 13 Jul 2017 Planned primary completion date changed from 1 Jul 2018 to 1 Sep 2018.
- 28 Sep 2016 Planned number of patients changed from 108 to 87.