Kinetics, Efficacy and Safety of C1-Esteraseremmer-N

NCT00119431 | Completed Phase 2

• 1 other identifier: KB2003.01A
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hereditary Angioedema Type I; Angioneurotic Edema

Keywords

Hereditary angioedema type I (MeSH: angioneurotic edema, complement 1 inactivators)

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics of C1-esteraseremmer-N versus Cetor.

Secondary Outcomes (1)

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

Interventions

C1 inhibitor concentrate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prothya Biosolutions: lead

Study Sites (2)

Academic Medical Centre

Amsterdam, 1100 DD, Netherlands

Location

Erasmus Medical Centre

Rotterdam, 3015 GD, Netherlands

Location

MeSH Terms

Conditions

Hereditary Angioedema Types I and II; Angioedema

Condition Hierarchy (Ancestors)

Angioedemas, Hereditary; Vascular Diseases; Cardiovascular Diseases; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• M. M. Levi, Prof. Dr.

  Academic Medical Centre Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 4, 2005
• First Posted: July 13, 2005
• Study Start: September 1, 2005
• Study Completion: March 1, 2006
• Last Updated: May 4, 2009

Record last verified: 2009-05

Locations

NL (2)