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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:
Pharming Technologies B.V.
ClinicalTrials.gov Identifier:
NCT00261053
First received: December 1, 2005
Last updated: April 24, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Genetic Disorders
 Drug: i.v. recombinant human C1 inhibitor
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

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

Secondary Outcome Measures:
  • Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics

Enrollment: 14
Study Start Date: June 2003
Study Completion Date: December 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Open-label i.v. administration of 100 U/kg rhC1INH
 Drug: i.v. recombinant human C1 inhibitor

  Eligibility

Ages Eligible for Study:   18 Years to 65 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: NCT00261053

Locations
Netherlands
For information contact Sonja Visscher
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

ClinicalTrials.gov Identifier: NCT00261053     History of Changes
Other Study ID Numbers: C1 1202-01
Study First Received: December 1, 2005
Last Updated: April 24, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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 23, 2013