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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01397864

Enrollment

181

Registered

2011-07-20

Start date

2011-07-31

Completion date

2024-12-10

Last updated

2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Angioedema

Keywords

Hereditary Angioedema, HAE, Angioedema, Recombinant C1 Inhibitor, rhC1INH, registry

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

Interventions

DRUGrhC1INH or pdC1INH

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
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

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

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026