Trial | NCT00261053  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    14
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.
Study Started
Jun 30
2003
Primary Completion
Sep 30
2005
Study Completion
Dec 31
2005
Last Update
Apr 25
2013
Estimate

Drug i.v. recombinant human C1 inhibitor

1 Other

Open-label i.v. administration of 100 U/kg rhC1INH

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
No Results Posted