Overview

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

Status:
Completed
Trial end date:
2007-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pharming Technologies B.V.
Treatments:
Complement C1 Inactivator Proteins
Complement C1 Inhibitor Protein
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