A Phase 2 HAE Prophylaxis Study With Recombinant Human C1 Inhibitor

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02247739
Study type	Interventional
Source	Pharming Technologies B.V.
Contact
Status	Completed
Phase	Phase 2
Start date	December 2014
Completion date	September 2016

View Details

See also
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