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

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• 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