Status:
COMPLETED
Kinetics, Efficacy and Safety of C1-Esteraseremmer-N
Lead Sponsor:
Prothya Biosolutions
Conditions:
Hereditary Angioedema Type I
Angioneurotic Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A multicentre study to investigate pharmacokinetics, clinical efficacy and safety of nanofiltered Cetor® (called C1-esteraseremmer-N during the development phase) for the treatment of hereditary angio...
Detailed Description
A multicentre study to investigate pharmacokinetics, clinical efficacy and safety of nanofiltered Cetor® (called C1-esteraseremmer-N during the development phase) for the treatment of hereditary angio...
Eligibility Criteria
Inclusion
- Established diagnosis of hereditary angioedema type I: i.e. markedly decreased C1 inhibitor activity, decreased level of C1 inhibitor antigen and a decreased level of C4.
- Age ≥ 18 years
- Body weight between 40 and 100 kg.
- Signed Informed consent
Exclusion
- C1 inhibitor infusion within the last 7 days
- Signs of any attack
- Angioedema attack within 7 days before actual infusion of study medication
- Change in the dosage of androgens in the last 14 days before the study
- Change in oral anticonceptive medication in the last two months before the study
- Pregnancy or lactation.
- B-cell malignancy
- Participation in another pharmaceutical clinical study, which can interfere with this study, in the last 3 months prior to the study
- History of clinically relevant antibody development to C1 inhibitor
- Use of oral anticoagulant medication in the last 14 days
- Use of heparin within the last two days prior to the study
- History of allergic reaction to C1 inhibitor concentrate or other blood products
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2006
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00119431
Start Date
September 1 2005
End Date
March 1 2006
Last Update
May 4 2009
Active Locations (2)
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1
Academic Medical Centre
Amsterdam, Netherlands, 1100 DD
2
Erasmus Medical Centre
Rotterdam, Netherlands, 3015 GD