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

Pharming Technologies B.V.181 enrolled

Overview

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.

see below

Study Type

OBSERVATIONAL

Enrollment

181

Conditions

Hereditary Angioedema

Interventions

rhC1INH or pdC1INHDRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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)

Locations (17)

UMHAT Alexandrovska EAD

Sofia, Bulgaria

KBC Split

Split, Croatia

General Hospital Sibenik

Šibenik, Croatia

Outcomes

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

Data from ClinicalTrials.gov

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