C1 Inhibitor Registry in the Treatment of Hereditary Angioedema (HAE) Attacks

Recruiting

• Conditions: Hereditary Angioedema
• Interventions: Drug: rhC1INH or pdC1INH

• Registration Number: NCT01397864
• Lead Sponsor: Pharming Technologies B.V.

Brief Summary

This is a non-interventional treatment Registry of Hereditary Angioedema (HAE) patients treated with C1 inhibitor, either plasma-derived (pdC1INH) or the recombinant human form (rhC1INH / Ruconest), to observe adverse events and insufficient efficacy, and to assess the immunological profile following single and repeated treatment with Ruconest.

Detailed Description

see below

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Decision to treat the HAE patient with C1 inhibitor (either Ruconest or pdC1INH)
• Patients must give written informed consent

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Exclusion Criteria

• A diagnosis of acquired C1INH deficiency (AAE)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hereditary Angioedema	rhC1INH or pdC1INH	-

Primary Outcome Measures

Name	Time	Method
The primary objective is to observe the adverse event profile and insufficient efficacy, following single and repeated treatment with Ruconest or pdC1INH of acute angioedema attacks	December 2019

Secondary Outcome Measures

Name	Time	Method
To assess the immunological profile of Ruconest (for suspected hypersensitivity or suspected neutralizing antibodies)	December 2019

Trial Locations

Locations (17)

PHI University Clinic of Dermatology; 🇲🇰 Skopje, North Macedonia

University Clinic Golnik; 🇸🇮 Golnik, Slovenia

Hospital A Michallon, CHU Grenoble; 🇫🇷 La Tronche, France

Alesund Hospital; 🇳🇴 Alesund, Norway

Bratislava University Hospital; 🇸🇰 Bratislava, Slovakia

University Hospital Martin; 🇸🇰 Martin, Slovakia

Faculty Hospital by St. Anna Brno; 🇨🇿 Brno, Czechia

UMHAT Alexandrovska EAD; 🇧🇬 Sofia, Bulgaria

KBC Split; 🇭🇷 Split, Croatia

CHC Sestre milosrdnice; 🇭🇷 Zagreb, Croatia

Semmelweis University, 3rd Department of Internal Medicine; 🇭🇺 Budapest, Hungary

General Hospital Sibenik; 🇭🇷 Šibenik, Croatia

Ospedale Luigi Sacco; 🇮🇹 Milan, Italy

Stavanger University Hospital; 🇳🇴 Stavanger, Norway

University Hospital Krakow; 🇵🇱 Krakow, Poland

Charite Universitatsmedizin Berlin; 🇩🇪 Berlin, Germany

Ryhof County Hospital; 🇸🇪 Jonkoping, Sweden