Berinert P Study of Subcutaneous Versus Intravenous Administration

NCT00748202 | Completed Phase 3

• 1 other identifier: CE1145_1001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The study is performed to investigate the subcutaneous (s.c.) versus intravenous (i.v.) administration of Berinert P in patients with hereditary angioedema (HAE) to establish a second administration mode in cases where i.v. access is not suitable. The study is planned as a single centre, randomized, open-label, cross-over pharmacokinetic study. Subjects will either start with s.c. or i.v. pasteurised C1-Inhibitor concentrate (Berinert P) and than switch to the treatment not administered before.

Conditions

Hereditary Angioedema

Keywords

Hereditary angioedema; C1-Esterase inhibitor; intravenous; subcutaneous; pharmacokinetic

Outcome Measures

Primary Outcomes (1)

• Individual courses of C1-inhibitor levels, from these will be derived pharmacokinetic parameters

  i.v. and s.c.samples: 0, 0.25, 0.5, 0.75 hours and 1, 2, 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 120, 168, 336 an 504 hours.

Secondary Outcomes (1)

• Safety of s.c. and i.v. administration of study medication

  2 years

Study Arms (2)

1

ACTIVE COMPARATOR

intravenous administration of C1-Inhibitor, after the end of the first observation period (at least after 7 days), each arm switches cross-over to the alternative administration mode not investigated so far

Drug: C1-Esterase Inhibitor

2

ACTIVE COMPARATOR

subcutaneous administration of C1-Inhibitor. After the end of the first observation period (at least after 7 days), each arm switches cross-over to the alternative administration mode not investigated so far.

Drug: C1-Esterase Inhibitor

Interventions

C1-Esterase Inhibitor DRUG

1000 I.E.

Also known as: Berinert P

1; 2

Eligibility Criteria

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

You may qualify if:

• Subjects with an established diagnosis of HAE type I (C1-Inhibitor activity \< 50% and C1-Inhibitor antigen \< 15.4 mg/dl) or HAE type II (C1-Inhibitor activity \< 50% and C1-Inhibitor antigen in normal or elevated concentration of dysfunctional protein).
• Male and female subjects with an age of at least 18 years.
• Subjects providing an informed consent.

You may not qualify if:

• Subjects without an established diagnosis of HAE.
• Last C1-INH administration less than 7 days ago and/or acute attack.
• Subjects with acquired angioedema (AAE).
• All other types of angioedema not associated with C1-INH deficiency.
• Treatment with any investigational drug (exclusive drugs appropriate for the treatment of acute angioedema) 30 days before study treatment.
• Treatment with any other drug appropriate for the treatment of acute angioedema within 7 days before start of study treatment at each phase.
• Danazol prophylaxis.
• Prophylaxis with antifibrinolytics, EACA, tranexamic acid.
• Subjects with a known hypersensitivity to study medication (Berinert P).
• Pregnant women (pregnancy rapid assay required for women with childbearing potential), women currently breast-feeding, or with the intention to breast-feed
• Subjects with malignant diseases.
• Subjects with immunodeficiencies such as established acquired immunodeficiency syndrome.
• Subjects with concurrent serious or acute illness or infection as per investigators judgement.
• Subjects with mental conditions which render the subject or its legally acceptable representative unable to understand the nature, scope and possible consequences of the study.

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead
• Clinical trial center Rhine-Main: collaborator
• ZKI Kindergerinnungslabor: collaborator
• Institut für Medizinische Virologie JWG-University hospital: collaborator
• CSL Behring: collaborator
• PharmaPart: collaborator
• University of Milan: collaborator

Study Sites (1)

Centre of Paediatrics III, Department of Haematology, Haemostaseology and Oncology, Comprehensive Care Centre for Thrombosis and Haemostasis, Johann-Wolfgang-Goethe-University Hospital

Frankfurt am Main, Hesse, 60590, Germany

Location

Related Publications (1)

• Martinez-Saguer I, Cicardi M, Suffritti C, Rusicke E, Aygoren-Pursun E, Stoll H, Rossmanith T, Feussner A, Kalina U, Kreuz W. Pharmacokinetics of plasma-derived C1-esterase inhibitor after subcutaneous versus intravenous administration in subjects with mild or moderate hereditary angioedema: the PASSION study. Transfusion. 2014 Jun;54(6):1552-61. doi: 10.1111/trf.12501. Epub 2013 Nov 24.

  PMID: 24266596 DERIVED

MeSH Terms

Conditions

Angioedemas, Hereditary

Interventions

Complement C1 Inhibitor Protein

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Complement C1 Inactivator Proteins; Serpins; Peptides; Amino Acids, Peptides, and Proteins; Complement Inactivator Proteins; Complement System Proteins; Immunoproteins; Blood Proteins; Proteins

Study Officials

• Wolfhart Kreuz, PD Phd

  Centre of Paediatrics III, Department of Haematology, Haemostaseology and Oncology, Comprehensive Care Centre for Thrombosis and Haemostasis, Johann-Wolfgang-Goethe-University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 4, 2008
• First Posted: September 8, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 19, 2011

Record last verified: 2011-01

Locations

DE (1)