Status:
COMPLETED
C1-Esteraseremmer-N for the Treatment of Hereditary (and Acquired) Angioedema
Lead Sponsor:
Prothya Biosolutions
Conditions:
Angioedema
Eligibility:
All Genders
16+ years
Phase:
PHASE2
PHASE3
Brief Summary
A multicentre study to investigate the pharmacokinetics, clinical efficacy and safety of nanofiltered Cetor® (called C1-esteraseremmer-N during the development phase) for the treatment of hereditary a...
Detailed Description
A multicentre study to investigate the pharmacokinetics, clinical efficacy and safety of nanofiltered Cetor® (called C1-esteraseremmer-N during the development phase) for the treatment of hereditary a...
Eligibility Criteria
Inclusion
- Inclusion criteria for hereditary angioedema patients:
- Established diagnosis of hereditary angioedema type I or II: markedly decreased C1 inhibitor activity; decreased (type I), normal or elevated (type II) level of C1 inhibitor antigen; decreased level of C4.
- Patients already using C1 inhibitor concentrate for prophylaxis of angioedema attacks.
- Age ≥ 16 years
- Signed informed consent by patient and patient's legal representative if under 18 years old
- Inclusion criteria for acquired angioedema patients:
- Established diagnosis of acquired angioedema: recurrent attacks of angioedema without urticaria; no family history; decreased functional C1 inhibitor; decreased level of C4.
- Autoantibodies to C1 inhibitor or decreased C1q or onset after the third decade of life.
- Age ≥ 16 years
- Patient already using C1 inhibitor concentrate for prophylaxis of angioedema attacks
- Signed informed consent by patient and patient's legal representative if under 18 years old
Exclusion
- Exclusion criteria for hereditary angioedema patients:
- Use of angioedema prophylactic medication during the study, other than C1-esteraseremmer-N.
- Change in oral contraceptives starting from the last two months before the start of the trial until the end of the study period.
- Presence of clinically relevant C1 inhibitor auto antibodies
- Participation in another pharmaceutical clinical study, which can interfere with this study, in the last 3 months prior to the study, other than in part A of this protocol.
- Usage of heparin starting from the last two days prior to the study until the end of the study period.
- B-cell malignancy
- Pregnancy or lactation
- History of allergic reaction to C1 inhibitor concentrate or other blood products
- Exclusion criteria for acquired angioedema patients:
- Participation in another pharmaceutical clinical study, which can interfere with this study, in the last 3 months prior to the study
- Usage of heparin within the last two days prior to the study
- Pregnancy or lactation
- History of allergic reaction to C1 inhibitor concentrate or other blood products
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2008
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00125541
Start Date
November 1 2006
End Date
May 1 2008
Last Update
May 4 2009
Active Locations (1)
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1
Academic Medical Centre
Amsterdam, Netherlands, 1100 DD