Kinetics, Efficacy and Safety of C1-Esteraseremmer-N

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanquin; Sanquin Plasma Products BV
• Treatments: Complement C1 Inactivator Proteins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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