NCT02247739

A Phase 2 HAE Prophylaxis Study With Recombinant Human C1 Inhibitor

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Pharming Technologies B.V. · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

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 description

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.

Conditions

• Hereditary Angioedema

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant human C1 inhibitor
OTHER	Placebo

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-05-01
• Completion: 2016-09-01
• First posted: 2014-09-25
• Last updated: 2017-12-08
• Results posted: 2017-12-08

Locations

10 sites across 7 countries: United States, Canada, Czechia, Italy, North Macedonia, Romania, Serbia