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

This study has been completed.

Sponsored by:	Pharming Technologies B.V.
Information provided by:	Pharming Technologies B.V.
ClinicalTrials.gov Identifier:	NCT00262288

Purpose

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.

Condition	Intervention	Phase
Genetic Disorders	Drug: i.v. recombinant human C1 inhibitor	Phase II Phase III

Drug Information available for: C1 esterase inhibitor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Pharming Technologies B.V.:

Primary Outcome Measures:

Primary outcomes: Relief of angioedema symptoms

Secondary Outcome Measures:

Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics

Estimated Enrollment:	30
Study Start Date:	April 2004

Eligibility

Ages Eligible for Study:	16 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262288

Locations

Netherlands
For information on sites in Europe, please contact Pharming Technologies.
Leiden, Netherlands, 2333 CN

Sponsors and Collaborators

Pharming Technologies B.V.

Investigators

Study Chair:

Jan Nuijens, MD, PhD

Pharming Technologies B.V.

More Information

Study ID Numbers:	C1 1203-01
Study First Received:	December 1, 2005
Last Updated:	February 1, 2008
ClinicalTrials.gov Identifier:	NCT00262288
Health Authority:	Netherlands: Independent Ethics Committee

Study placed in the following topic categories:

Hypersensitivity
Genetic Diseases, Inborn
Skin Diseases
Angioedema
Hypersensitivity, Immediate

Vascular Diseases
Urticaria
Angioedema, Hereditary
Hereditary angioedema

Additional relevant MeSH terms:

Skin Diseases, Vascular
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009