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

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.

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Key information

Conditions

Hereditary Angioedema Angioedema Angioedemas, Hereditary Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Complement Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

UMHAT Alexandrovska EAD, Sofia, Bulgaria

About this study

see below

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

rhC1INH or pdC1INH

Drug

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

Other names: Ruconest

Primary outcomes

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

Time frame: December 2019

Secondary outcomes

To assess the immunological profile of Ruconest (for suspected hypersensitivity or suspected neutralizing antibodies)

Time frame: December 2019

Sponsors and collaborators

Lead sponsor

Pharming Technologies B.V.

Industry

Registry information

Official study title

C1 Inhibitor Treatment Registry to Assess the Safety and Immunological Profile of Ruconest in the Treatment of HAE Attacks

Important dates

Study start: 2011
Primary completion: 2024
Study completion: 2024
First posted: Jul 20, 2011
Registry last updated: Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed