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

A Phase II/III Study of the Efficacy and Safety of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00262288

Enrollment

Registered

2005-12-06

Start date

2004-04-30

Completion date

2007-01-31

Last updated

2013-02-22

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 multi-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

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 70 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	24 hours

Secondary

Measure	Time frame
Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics	90 days

Countries

Netherlands

Outcome results

None listed

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