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

Genetic Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00262288
• Other study ID #: C1 1203-01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 1, 2005
• Last updated: February 21, 2013
• Start date: April 2004
• Est. completion date: January 2007

Study information

• Verified date: February 2013
• Source: Pharming Technologies B.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioedema
• Genetic Disorders

Intervention

Drug:
• i.v. recombinant human C1 inhibitor

Locations

Country	Name	City	State
Netherlands	For information on sites in Europe, please contact Pharming Technologies.	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Pharming Technologies B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcomes: Relief of angioedema symptoms		24 hours	No
Secondary	Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics		90 days	Yes