Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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
  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: 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:


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

Primary Outcome Measures:
  • Primary outcomes: Relief of angioedema symptoms [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics [ Time Frame: 90 days ]

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   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

ClinicalTrials.gov processed this record on May 23, 2017