Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

A Phase II Exploratory, Open-label Study of the Safety and Efficacy of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00261053

Enrollment

Registered

2005-12-02

Start date

2003-06-30

Completion date

2005-12-31

Last updated

2013-04-25

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

Conditions

Genetic Disorders

Brief summary

The purpose of this single-center study is to explore the efficacy, safety, tolerability and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute attacks in patients with hereditary angioedema.

Interventions

DRUGi.v. recombinant human C1 inhibitor

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Main inclusion Criteria: * Clinical and laboratory diagnosis of HAE * Plasma level of functional C1INH of less than 50% of normal * Severe attack of abdominal, facial-oro-pharyngeal, genito-urinary and/or peripheral HAE. Main

Exclusion criteria

* Acquired angioedema * Pregnancy or breastfeeding * Participation in another clinical study within prior 3 months

Design outcomes

Primary

Measure	Time frame
Primary outcomes: Relief of angioedema symptoms	—

Secondary

Measure	Time frame
Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics	—

Countries

Netherlands

Outcome results

None listed

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