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

Sponsor
Pharming Technologies B.V. (Industry)
Overall Status
Completed
CT.gov ID
NCT00262288
Collaborator
(none)
14
Enrollment
1
Location
1
Arm
33
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: i.v. recombinant human C1 inhibitor
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
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 :
Apr 1, 2004
Actual Primary Completion Date :
Jan 1, 2007
Actual Study Completion Date :
Jan 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Recombinant Human C1INH

Drug: i.v. recombinant human C1 inhibitor
Other Names:
  • rhC1INH

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Primary outcomes: Relief of angioedema symptoms [24 hours]

    Secondary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pharming Technologies B.V.
    ClinicalTrials.gov Identifier:
    NCT00262288
    Other Study ID Numbers:
    • C1 1203-01
    First Posted:
    Dec 6, 2005
    Last Update Posted:
    Feb 22, 2013
    Last Verified:
    Feb 1, 2013
    Additional relevant MeSH terms:
    Angioedema
    Angioedemas, Hereditary
    Genetic Diseases, Inborn
    Complement C1 Inhibitor Protein

    Study Results

    No Results Posted as of Feb 22, 2013