Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

Phase 2

Completed

• Conditions: Genetic Disorders
• Interventions: Drug: i.v. recombinant human C1 inhibitor

• Registration Number: NCT00261053
• Lead Sponsor: Pharming Technologies B.V.

Brief Summary

The purpose of this single-center study is to explore the efficacy, safety, tolerability and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute attacks in patients with hereditary angioedema.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2005-09
• Study Completion: 2005-12
• Study First Submitted: 2005-12-01
• Study First Submitted QC: 2005-12-01
• Study First Posted: 2005-12-02
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-24
• Last Update Posted: 2013-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	i.v. recombinant human C1 inhibitor	Open-label i.v. administration of 100 U/kg rhC1INH

Primary Outcome Measures

Name	Time	Method
Primary outcomes: Relief of angioedema symptoms

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics

Trial Locations

Locations (1)

For information contact Sonja Visscher; 🇳🇱 Leiden, Netherlands