CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 46 enrolled
Drug / intervention
Berinert, lyophilizate for IV application containing 500 IU C1-INH to be reconstituted with 10 mL water for injectionbiological
Likely dose
Berinert, lyophilizate for IV application containing 500 IU C1-INH to be reconstituted with 10 mL water for injectionfrom record
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Search/NCT01467947
NCT01467947Phase 4Completed
CompareCT.gov

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

CSL Behring·interventional·Posted Nov 9, 2011·Updated Feb 6, 2017

In Brief

A Phase 4 clinical trial evaluating Berinert, lyophilizate for IV application containing 500 IU C1-INH to be reconstituted with 10 mL water for injection for Hereditary Angioedema Types I and II. Completed, enrolled 46 participants across 4 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema Types I and II
CountriesBulgaria, Hungary, Poland, Romania
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 9, 2011
Enrollment StartNov 1, 2011
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 14.6 years ago

Interventions

Berinert, lyophilizate for IV application containing 500 IU C1-INH to be reconstituted with 10 mL water for injectionbiological

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.