A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Evaluate the Efficacy and Safety of Recombinant Human C1 Inhibitor in the Prophylaxis of Angioedema Attacks in Patients With Hereditary Angioedema (HAE)
Phase of Trial: Phase II
Latest Information Update: 11 Sep 2017
At a glance
- Drugs Conestat alfa (Primary)
- Indications Hereditary angioedema
- Focus Therapeutic Use
- Sponsors Pharming Group NV
- 11 Sep 2017 According to a Pharming Group media release, base on the data from this and OPERA study, company will submit a BLA efficacy supplement (sBLA) to include routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE) as an expanded indication for RUCONEST (Conestat-alfa) in Q4 2017.
- 27 Jul 2017 Results published in the Lancet.
- 27 Jul 2017 Planned locations also included Poland.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History