Kinetics, Efficacy and Safety of C1-Esteraseremmer-N
Status:
Completed
Trial end date:
2006-03-01
Target enrollment:
Participant gender:
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 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). Part B + C will provide
data on the efficacy of C1-esteraseremmer-N.
The changes in the manufacturing process of C1-esteraseremmer-N, compared to Cetor® (the
currently marketed C1-inhibitor product), nanofiltration and omission of hepatitis B
immunoglobulin, most likely will not affect tolerability. The nanofiltration will provide
more safety regarding viruses.
In part A, the pharmacokinetics of C1-esteraseremmer-N in patients with hereditary angioedema
will be compared with the current registered product, Cetor®, in a randomised, blinded
cross-over design. This study has to provide evidence that changes in the manufacturing
process have not affected pharmacokinetics. In addition, this study provides data on safety
of C1-esteraseremmer-N.