Hereditary Angioedema (HAE) MedDRA version: 14.1 Level: LLT Classification code 10056912 Term: C1 esterase inhibitor deficiency System Organ Class: 100000004850
Conditions
Interventions
Trade Name: BERINERT*IV FL 500U+FL 10ML
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: CE1145
Concentration unit: U unit(s)
Concentration type: equal
Concentra
Sponsors
AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who suffer from frequent angioedema attacks (every 3-7 days) in whom infused CE1145 is rapidly catabolized and does not significantly modify C4 levels. Written informed consent for study participation obtained before undergoing any study specific procedures. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: • Absence of HAE attack in the last 30 days before study enrolment. • Participation in another clinical study (or use of another investigational medicinal product [IMP]) within 30 days before, or during, the study. • History of alcohol, drug, or medication abuse within one year before the study. • Use of concomitant therapy not permitted during the study. • Suspected inability (eg, language problems) or unwillingness to comply with study procedures. • Mental condition rendering the subject (or the subject’s legally acceptable representative[s]) unable to understand the nature, scope and possible consequences of the study). • Known or suspected hypersensitivity to the IMP, or to any excipients of the IMP. • Known or suspected antibodies to the IMP, or to any excipients of the IMP. • Any condition that is likely to interfere with evaluation of the IMP or satisfactory conduct of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the PK profile of CE1145 in patients with weekly angioedema attacks and rapid clearance of C1-INH from plasma after normalising activation of the complement and contact system by replacing the total C1-esterase inhibitor (C1-INH) plasma pool with repetitive C1-INH administrations.;Secondary Objective: The secondary objective of the study is to assess the safety of C1-INH treatment in these subjects.;Primary end point(s): PK of i.v. administration of study medication at steady state under normalised activity of C1-INH.;Timepoint(s) of evaluation of this end point: Week 9 of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety of i.v. administration of study medication at high doses.;Timepoint(s) of evaluation of this end point: Week 9 of the study. | — |
Countries
Italy
Contacts
Public ContactU. O. Medicina II
Ospedale Luigi Sacco
Outcome results
None listed