Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01467947|
Recruitment Status : Completed
First Posted : November 9, 2011
Results First Posted : November 16, 2015
Last Update Posted : February 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hereditary Angioedema Types I and II||Biological: Berinert, lyophilizate for IV application containing 500 IU C1-INH to be reconstituted with 10 mL water for injection||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
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.
- Number of Subjects With Inhibitory Anti-C1-esterase-inhibitor Antibodies [ Time Frame: Baseline to approximately 9 months ]Subjects with no positive baseline result and at least one positive post-baseline result for inhibitory anti-C1-INH antibodies.
- Number of Subjects With Any (Inhibitory or Non-inhibitory) Anti-C1-esterase-inhibitor Antibodies [ Time Frame: Baseline to approximately 9 months ]Subjects with at least one positive result for inhibitory or non-inhibitory anti-C1-INH antibodies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467947
|MHAT "Tsaritsa Yoanna"|
|Sofia, Bulgaria, 1504|
|Budapest, Hungary, 1125|
|Krakow, Poland, 31-531|
|Spitalul Clinic Judeţean Mureş,Secţia Clinică Medicină Internă,Compartimentul Alergologie şi Imunologie|
|Târgu-Mures, Mureş, Romania, Cod 540103|
|Study Director:||Mikhail Rojavin||CSL Behring|