Clinical Trial: A Phase 2 HAE Prophylaxis Study With Recombinant Human C1 Inhibitor

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Primary Objective:

To evaluate the efficacy of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE

Secondary Objective:

To evaluate the safety and immunogenicity of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE

Detailed Summary:

Study Design:

This is a multi-center, randomized, double-blind, placebo-controlled, 3-period crossover study of rhC1INH in prophylaxis of angioedema attacks in patients with HAE.

Medical screening (clinical and laboratory parameters) will be performed and patient medical history specific to HAE attacks will be collected to assess eligibility. Each patient will receive three 4 week periods of treatment twice weekly.

Sponsor: Pharming Technologies B.V.

Current Primary Outcome: Number of HAE attacks [ Time Frame: 28 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse events [ Time Frame: 20 weeks ]

Original Secondary Outcome: Same as current

Information By: Pharming Technologies B.V.

Dates:
Date Received: September 16, 2014
Date Started: December 2014
Date Completion:
Last Updated: October 14, 2016
Last Verified: October 2016