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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pharming Technologies B.V.
ClinicalTrials.gov Identifier:
NCT00262288
First received: December 1, 2005
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  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 2
Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Primary outcomes: Relief of angioedema symptoms [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: April 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Recombinant Human C1INH Drug: i.v. recombinant human C1 inhibitor
Other Name: rhC1INH

  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

No publications provided

Responsible Party: Pharming Technologies B.V.
ClinicalTrials.gov Identifier: NCT00262288     History of Changes
Other Study ID Numbers: C1 1203-01
Study First Received: December 1, 2005
Last Updated: February 21, 2013
Health Authority: Netherlands: Independent Ethics Committee

Additional relevant MeSH terms:
Angioedema
Angioedemas, Hereditary
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
 Immune System Diseases
Complement C1
Complement C1 Inhibitor Protein
Complement C1 Inactivator Proteins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Complement Inactivating Agents
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 16, 2013