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

NCT ID: NCT01397864

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

181 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2024-12-10

Brief Summary

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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

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see below

Conditions

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Hereditary Angioedema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hereditary Angioedema

rhC1INH or pdC1INH

Intervention Type DRUG

C1 inhibitor, either plasma-derived (pdC1INH) or the recombinant human form (Ruconest)

Interventions

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rhC1INH or pdC1INH

C1 inhibitor, either plasma-derived (pdC1INH) or the recombinant human form (Ruconest)

Intervention Type DRUG

Other Intervention Names

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Ruconest

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* A diagnosis of acquired C1INH deficiency (AAE)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharming Technologies B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anurag Relan, MD

Role: STUDY_DIRECTOR

Pharming Technologies BV

Locations

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UMHAT Alexandrovska EAD

Sofia, , Bulgaria

Site Status

KBC Split

Split, , Croatia

Site Status

General Hospital Sibenik

Šibenik, , Croatia

Site Status

CHC Sestre milosrdnice

Zagreb, , Croatia

Site Status

Faculty Hospital by St. Anna Brno

Brno, , Czechia

Site Status

Hospital A Michallon, CHU Grenoble

La Tronche, , France

Site Status

Charite Universitatsmedizin Berlin

Berlin, , Germany

Site Status

Semmelweis University, 3rd Department of Internal Medicine

Budapest, , Hungary

Site Status

Ospedale Luigi Sacco

Milan, , Italy

Site Status

PHI University Clinic of Dermatology

Skopje, , North Macedonia

Site Status

Alesund Hospital

Ålesund, , Norway

Site Status

Stavanger University Hospital

Stavanger, , Norway

Site Status

University Hospital Krakow

Krakow, , Poland

Site Status

Bratislava University Hospital

Bratislava, , Slovakia

Site Status

University Hospital Martin

Martin, , Slovakia

Site Status

University Clinic Golnik

Golnik, , Slovenia

Site Status

Ryhof County Hospital

Jönköping, , Sweden

Site Status

Countries

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Bulgaria Croatia Czechia France Germany Hungary Italy North Macedonia Norway Poland Slovakia Slovenia Sweden

Other Identifiers

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C1 1412

Identifier Type: -

Identifier Source: org_study_id

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