Explore the effect of rC1INH in patients with HAE in preventing the occurence of acute HAE attacks.
Conditions
Interventions
Product Name: Recombinant C1 inhibitor
Product Code: rC1IHN
Pharmaceutical Form: Powder for solution for injection
Sponsors
Pharming Technologies B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Aged at least 18 years • Signed written informed consent • Confirmed diagnosis of HAE with baseline plasma level of functional C1INH activity of less than 50 % of normal, and/or proven HAE mutation in C1INH gene • The occurence of an HAE attack at least every fortnight Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • A history of anaphylaxis or severe allergy (i.e. requiring medication) to food, proteins and/or drugs. • A history of allergic reactions to C1INH products or rabbit protein. • Any reported SAE related to eventual previous rC1INH administration (withdrawal criterium). • Elevated IgE against rabbit dander (>0.35 kU/L; ImmunoCap assay; Phadia) • A diagnosis of acquired C1INH deficiency (exclude patients with AAE). • Women of child bearing potential, who are (or intent to become) pregnant or breast-feeding. • Participation in another clinical study in the last month prior to this study • Treatment with C1INH concentrates or any blood or plasma-derived material (e.g. fresh-frozen plasma) within 7 days prior to treatment with rC1INH. • Any clinically significant abnormality in the routine haematology, biochemistry and urinalysis. • Any condition or treatment that in the opinion of the investigator might interfere with the evaluation of the study objectives. • Treatment with anticoagulants (e.g) heparin or warfarin) in the last 3 days preceding treatment with rC1INH. • Any changes since screening that would exclude subject based on above exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the occurrence of HAE attacks under prophylactic administration of rC1INH (50 U/kg, once a week);Secondary Objective: To evaluate the PK parameters, safety and immunogenicity on repeated administration of rC1INH ;Primary end point(s): Frequency of breakthrough attacks of HAE. | — |
Countries
Hungary
Outcome results
None listed