Berinert P Study of Subcutaneous Versus Intravenous Administration (PASSION)

January 18, 2011 updated by: Johann Wolfgang Goethe University Hospital

Pharmacokinetics Berinert P Study of Subcutaneous Versus Intravenous Administration in Subjects With Moderate Hereditary Angioedema - The Passion Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with hereditary angioedema (HAE), suffer from recurring and mostly unforeseeable attacks of acute oedema of subcutaneous tissues of various organs. The pathophysiological correlate of this disease is a deficiency in functionally active C1-Esterase Inhibitor (C1-INH). Today, two main types of HAE are described. In HAE type I, an impaired synthesis and an elevated turnover of a normal and functional active C1-INH molecule takes place, causing reduced amounts in functionally active C1-INH. In HAE type II, normal levels of a functionally impaired C1-INH molecule are synthesized. Both defects are inherited as an autosomal dominant trait. HAE type III is limited to females and not associated with C1-INH deficiency; the pathophysiology of this type remains to be determined. Corticosteroids, antihistamines or epinephrine usually do not exert any positive effect in acute attacks caused by HAE. This is of particular importance as these types of medication are often used in case of oedema in general. In case of acute oedema in patients suffering from HAE, the intravenous administration of C1-INH concentrate (e.g., Berinert P) is the treatment of choice. The study is performed to investigate the s.c. versus 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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Centre of Paediatrics III, Department of Haematology, Haemostaseology and Oncology, Comprehensive Care Centre for Thrombosis and Haemostasis, Johann-Wolfgang-Goethe-University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
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
1000 I.E.
Other Names:
  • Berinert P
ACTIVE_COMPARATOR: 2
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
1000 I.E.
Other Names:
  • Berinert P

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Individual courses of C1-inhibitor levels, from these will be derived pharmacokinetic parameters
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Time Frame
Safety of s.c. and i.v. administration of study medication
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Collaborators

CSL Behring
University of Milan
PharmaPart
Clinical trial center Rhine-Main
ZKI Kindergerinnungslabor
Institut für Medizinische Virologie JWG-University hospital

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

September 4, 2008

First Submitted That Met QC Criteria

September 4, 2008

First Posted (ESTIMATE)

September 8, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 19, 2011

Last Update Submitted That Met QC Criteria

January 18, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE1145_1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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