Hereditary Angioedema Clinical Trial
Official title:
Open-label, Phase II, Single Arm Study to Evaluate the Safety, Immunogenicity, Pharmacokinetics and Efficacy of rhC1INH for the Treatment of Acute Attacks in Pediatric Patients With Hereditary Angioedema, From 2-13 Years of Age
This open-label study is being conducted to confirm the safety, pharmacokinetic profile and efficacy of Ruconest at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in patients, from 2 up to and including 13 years of age.
This study was an open-label, Phase 2, non-comparative, multinational, multicenter clinical study in pediatric patients from 2 up to and including 13 years of age, with a confirmed diagnosis of HAE. Patients were eligible for treatment with recombinant human C1-inhibitor (rhC1INH) if they presented to the clinic within 5 hours of onset with an acute attack of at least moderate severity without signs of spontaneous regression. Patients received rhC1INH at a dose of 50 U/kg body weight up to a maximum of 4200 U. The reconstituted solution was administered as a slow intravenous (iv) injection over approximately 5 minutes. The patients remained in hospital and were closely monitored in the study center for at least 4 hours after study medication administration. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT06007677 -
A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema
|
Phase 2 | |
| Completed |
NCT00997204 -
EASSI - Evaluation of the Safety of Self-Administration With Icatibant
|
Phase 3 | |
| Completed |
NCT00438815 -
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks
|
Phase 3 | |
| Completed |
NCT00748202 -
Berinert P Study of Subcutaneous Versus Intravenous Administration
|
Phase 3 | |
| Completed |
NCT01426763 -
A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase
|
Phase 2 | |
| Terminated |
NCT04091113 -
Hereditary Angioedema Kininogen Assay
|
||
| Completed |
NCT00432510 -
Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects
|
Phase 1 | |
| Completed |
NCT03712228 -
A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)
|
Phase 2 | |
| Active, not recruiting |
NCT05453968 -
Berotralstat Treatment in Children With Hereditary Angioedema
|
Phase 3 | |
| Recruiting |
NCT05511922 -
PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial
|
Phase 3 | |
| Recruiting |
NCT05505916 -
An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
|
Phase 3 | |
| Completed |
NCT02303626 -
12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT02159430 -
Hereditary AngioEdema, Neurobiology and Psychopathology
|
N/A | |
| Completed |
NCT01984788 -
Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE
|
Phase 2 | |
| Completed |
NCT04888650 -
Assessment of the State of Health, Quality of Life and Expectations of Patients With Hereditary Angioedema
|
||
| Completed |
NCT02448264 -
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers
|
Phase 1 | |
| Completed |
NCT05118958 -
Phase 1 Crossover Study in Healthy Subjects to Evaluate the PK Profile of KVD824 Following Single and Multiple Doses of Modified Release (MR) Formulations
|
Phase 1 | |
| Completed |
NCT06414252 -
Social Evaluated Cold Pressor Test in Hereditary Angioedema Patients
|
||
| Active, not recruiting |
NCT04739059 -
Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks
|
Phase 3 | |
| Completed |
NCT02819102 -
An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates
|
Phase 1 |