Kinetics, Efficacy and Safety of C1-Esteraseremmer-N

Phase 2CompletedNCT00119431

Prothya Biosolutions12 enrolled

Overview

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.

Study Type

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Kinetics, Efficacy and Safety of C1-Esteraseremmer-N

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes