Kinetics, Efficacy and Safety of C1-Esteraseremmer-N

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00119431
• Date of registration: 04/07/2005
• Prospective Registration: Yes
• Primary sponsor: Sanquin
• Public title: Kinetics, Efficacy and Safety of C1-Esteraseremmer-N
• Scientific title: Pharmacokinetics, Clinical Efficacy and Safety of C1 Inhibitor Concentrate (C1-Esteraseremmer-N) for the Treatment of Hereditary (and Acquired) Angioedema
• Date of first enrolment: September 2005
• Target sample size: 12
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00119431
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention
• Phase: Phase 2

Countries of recruitment

Netherlands

Contacts

• Name: M. M. Levi, Prof. Dr.
• Affiliation: Academic Medical Centre Amsterdam

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hereditary Angioedema Type I

Angioneurotic Edema

Intervention(s)

Drug: C1 inhibitor concentrate

Primary Outcome(s)

Pharmacokinetics of C1-esteraseremmer-N versus Cetor.

Secondary Outcome(s)

Laboratory and clinical safety as well as clinical tolerance of C1-esteraseremmer-N versus current Cetor.

Secondary ID(s)

KB2003.01A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors