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

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ClinicalTrials.gov Identifier: NCT00262288
Recruitment Status : Completed
First Posted : December 6, 2005
Last Update Posted : February 22, 2013
Sponsor:
Information provided by (Responsible Party):
Pharming Technologies B.V.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Genetic Disorders Drug: i.v. recombinant human C1 inhibitor Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2004
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Recombinant Human C1INH Drug: i.v. recombinant human C1 inhibitor
Other Name: rhC1INH


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

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

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Pharming Technologies B.V.
ClinicalTrials.gov Identifier: NCT00262288     History of Changes
Other Study ID Numbers: C1 1203-01
First Posted: December 6, 2005    Key Record Dates
Last Update Posted: February 22, 2013
Last Verified: February 2013

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 Inactivator Proteins
Complement C1 Inhibitor Protein
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs