Angioedema Clinical Trial
Official title:
Pharmacokinetics, Clinical Efficacy and Safety of C1 Inhibitor Concentrate (C1-Esteraseremmer-N) for the Treatment of Hereditary (and Acquired) Angioedema
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 angioedema (HAE) will be performed. This study (KB2003.01) consists
of three parts: Part A - pharmacokinetics (phase II); Part B - treatment of attacks of
angioedema (phase III); and Part C - prophylactic use of C1 inhibitor (phase III). Parts B +
C will provide data on the efficacy of C1-esteraseremmer-N.
The changes within the manufacturing process of C1-esteraseremmer-N, compared to Cetor®
nanofiltration and omission of hepatitis B immunoglobulin, most likely will not affect
tolerability. The nanofiltration will provide more safety regarding viruses.
In Part B of the study, 15 attacks of hereditary angioedema will be treated with open-label
C1-esteraseremmer-N. Attack severity and duration will be monitored by the subjective
experience of the patient himself (which has been shown to be the most sensitive way of
monitoring attack severity) and compared with historical (and literature) data. If possible,
some attacks of acquired angioedema will also be included.
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 angioedema (HAE) will be performed. This study (KB2003.01) consists
of three parts: Part A - pharmacokinetics (phase II); Part B - treatment of attacks of
angioedema (phase III); and Part C - prophylactic use of C1 inhibitor (phase III). Parts B +
C will provide data on the efficacy of C1-esteraseremmer-N.
The changes within the manufacturing process of C1-esteraseremmer-N, compared to Cetor®
nanofiltration and omission of hepatitis B immunoglobulin, most likely will not affect
tolerability. The nanofiltration will provide more safety regarding viruses.
In Part B of the study, 15 attacks of hereditary angioedema will be treated with open-label
C1-esteraseremmer-N. Attack severity and duration will be monitored by the subjective
experience of the patient himself (which has been shown to be the most sensitive way of
monitoring attack severity) and compared with historical (and literature) data. If possible,
some attacks of acquired angioedema will also be included.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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