Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert
This study is currently recruiting participants.
Verified April 2013 by CSL Behring
Sponsor:
CSL Behring
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT01467947
First received: November 7, 2011
Last updated: May 1, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by CSL Behring:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 48 |
| Study Start Date: | November 2011 |
| Estimated Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Berinert |
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.
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of congenital C1-INH deficiency (HAE type I or II) with 3 to 6 HAE attacks in the previous 6 months prior to study entry.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467947
Contacts
| Contact: Clinical trial Registration Coordinator | clinicaltrials@cslbehring.com |
Locations
| Hungary | |
| Semmelweis University | Recruiting |
| Budapest, Hungary, 1125 | |
| Contact: Henriette Farkas | |
| Poland | |
| Jagiellonian University | Recruiting |
| Krakow, Poland, 31-531 | |
| Contact: Krystyna Obtulovicz, Prof Dr | |
| Romania | |
| Spitalul Clinic Judeţean Mureş,Secţia Clinică Medicină Internă,Compartimentul Alergologie şi Imunologie | Recruiting |
| Târgu-Mures, Mureş, Romania, Cod 540103 | |
| Contact: Dumitru MOLDOVAN, Dr 0040742 121 885 | |
Sponsors and Collaborators
CSL Behring
Investigators
| Study Director: | Mikhail Rojavin | CSL Behring |
More Information
No publications provided
| Responsible Party: | CSL Behring |
| ClinicalTrials.gov Identifier: | NCT01467947 History of Changes |
| Other Study ID Numbers: | CE1145_4001, 2010-024242-30 |
| Study First Received: | November 7, 2011 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Food and Drug Administration Romania: National Medicines Agency |
Additional relevant MeSH terms:
|
Angioedema Angioedemas, Hereditary Hereditary Angioedema Types I and II Vascular Diseases Cardiovascular Diseases Urticaria Skin Diseases, Vascular Skin Diseases Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Genetic Diseases, Inborn Complement C1 Inhibitor Protein Complement Inactivating Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013