A Randomized, Global, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Once-daily Oral Avatrombopag for the Treatment of Adults With Thrombocytopenia Associated With Liver Disease Prior to an Elective Procedure
Phase of Trial: Phase III
Latest Information Update: 22 Sep 2017
At a glance
- Drugs Avatrombopag (Primary)
- Indications Thrombocytopenia
- Focus Registrational; Therapeutic Use
- Acronyms ADAPT II
- Sponsors Dova Pharmaceuticals; Eisai Inc
- 22 Sep 2017 According to a Dova Pharmaceuticals media release, based on the data from ADAPT-1 and ADAPT-2 trials the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for avatrombopag, for the treatment of thrombocytopenia in patients with chronic liver disease (CLD) who are scheduled to undergo a procedure.
- 22 Sep 2017 Results published in a Dova Pharmaceuticals media release.
- 22 Sep 2017 Primary endpoint has been met. (Proportion of participants who do not require a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following an elective procedure), according to a Dova Pharmaceuticals media release.