Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT01467947
First received: November 7, 2011
Last updated: September 1, 2014
Last verified: September 2014

November 7, 2011
September 1, 2014
November 2011
January 2015   (final data collection date for primary outcome measure)
Incidence of subjects with inhibitory anti-C1-esterase-inhibitor antibodies [ Time Frame: Period of 9 months (baseline to Day 273) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01467947 on ClinicalTrials.gov Archive Site
Proportion of subjects with any (inhibitory or non-inhibitory) anti-C1-esterase-inhibitor antibodies [ Time Frame: Period of 9 months (baseline to Day 273) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert
Prospective Open-label Uncontrolled Multi-center Post-marketing Study to Assess Inhibitory Antibody Formation in Subjects With Congenital C1-INH Deficiency and Acute Hereditary Angioedema (HAE) Attacks Treated With Berinert® , a C1-esterase Inhibitor

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 U Berinert/kg body weight per attack.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hereditary Angioedema Types I and II
Biological: Berinert, lyophilisate for IV application containing 500 units (U) 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 U Berinert/kg body weight.
Experimental: Berinert
Intervention: Biological: Berinert, lyophilisate for IV application containing 500 units (U) C1-INH to be reconstituted with 10 mL water for injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
48
Not Provided
January 2015   (final data collection date for primary outcome measure)

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 (AAE) 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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland,   Bulgaria,   Hungary,   Romania
 
NCT01467947
CE1145_4001, 2010-024242-30
Not Provided
CSL Behring
CSL Behring
Not Provided
Study Director: Mikhail Rojavin CSL Behring
CSL Behring
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP