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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01467947
Other study ID # CE1145_4001
Secondary ID 2010-024242-30
Status Completed
Phase Phase 4
First received November 7, 2011
Last updated October 16, 2015
Start date November 2011
Est. completion date October 2014

Study information

Verified date October 2015
Source CSL Behring
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationRomania: National Medicines AgencyBulgaria: Bulgarian Drug AgencyHungary: National Institute for Quality and Organizational Development in Healthcare and MedicinesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Study type Interventional

Clinical Trial Summary

This is a prospective, international, multi-center, non-randomized, single arm, open-label, postmarketing study to investigate the formation of inhibitory anti-C1-INH antibodies in HAE subjects treated intravenously with Berinert. Individual treatment duration per subject is 9 months, irrespective of the number of treated attacks. All subjects will receive 20 IU Berinert/kg body weight per attack.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of congenital C1-INH deficiency (HAE type I or II) and assessed by the investigator to likely require intravenous (IV) Berinert treatment during the study period.

- Male or female, = 12 years of age at the time of signing informed consent.

- Written informed consent for study participation obtained before undergoing any study specific procedures.

Exclusion Criteria:

- Incurable malignancies in the last 6 months prior to study entry.

- Acquired angioedema due to C1-INH deficiency.

- All other types of angioedema not associated with C1-INH deficiency.

- Use of any C1-INH products other than Berinert within 30 days before the study, or planned use during the study.

- Immunization within 30 days prior to study entry.

- Autoimmune conditions requiring use of immunosuppressants during the study.

- Known or suspected hypersensitivity to C1-INH.

- Participation in any of the previous Berinert studies from which anti-C1-INH antibody results were submitted to the Food and Drug Administration.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
Berinert, lyophilizate for IV application containing 500 IU C1-INH to be reconstituted with 10 mL water for injection
Individual treatment duration per subject is 9 months, irrespective of the number of treated attacks. Each attack that occurs in this time frame will be treated with 20 IU Berinert/kg body weight.

Locations

Country Name City State
Bulgaria MHAT "Tsaritsa Yoanna" Sofia
Hungary Semmelweis University Budapest
Poland Jagiellonian University Krakow
Romania Spitalul Clinic Judetean Mures,Sectia Clinica Medicina Interna,Compartimentul Alergologie si Imunologie Târgu-Mures Mures

Sponsors (1)

Lead Sponsor Collaborator
CSL Behring

Countries where clinical trial is conducted

Bulgaria,  Hungary,  Poland,  Romania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects With Inhibitory Anti-C1-esterase-inhibitor Antibodies Subjects with no positive baseline result and at least one positive post-baseline result for inhibitory anti-C1-INH antibodies. Baseline to approximately 9 months No
Secondary Number of Subjects With Any (Inhibitory or Non-inhibitory) Anti-C1-esterase-inhibitor Antibodies Subjects with at least one positive result for inhibitory or non-inhibitory anti-C1-INH antibodies. Baseline to approximately 9 months No
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Active, not recruiting NCT05047185 - Dose-ranging Study of Oral PHA-022121 for Prophylaxis Against Angioedema Attacks in Patients With Hereditary Angioedema Type I or Type II Phase 2