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)

Trial Profile

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)

Completed
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
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top