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NCT01397864 Clinical Trial

C1 Inhibitor Registry in the Treatment of Hereditary Angioedema (HAE) Attacks

Hereditary Angioedema Clinical Trial

Official title:
C1 Inhibitor Treatment Registry to Assess the Safety and Immunological Profile of Ruconest in the Treatment of HAE Attacks

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01397864
Other study ID # C1 1412
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 2011
Est. completion date January 2025

Study information
Verified date February 2024
Source Pharming Technologies B.V.
Contact Miranda Boshuizen
Phone +31 71 5247 400
Email m.boshuizen@pharming.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a non-interventional treatment Registry of Hereditary Angioedema (HAE) patients treated with C1 inhibitor, either plasma-derived (pdC1INH) or the recombinant human form (rhC1INH / Ruconest), to observe adverse events and insufficient efficacy, and to assess the immunological profile following single and repeated treatment with Ruconest.

Description:

see below

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Decision to treat the HAE patient with C1 inhibitor (either Ruconest or pdC1INH) - Patients must give written informed consent Exclusion Criteria: - A diagnosis of acquired C1INH deficiency (AAE)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• rhC1INH or pdC1INH
C1 inhibitor, either plasma-derived (pdC1INH) or the recombinant human form (Ruconest)

Locations
Country Name City State
Bulgaria UMHAT Alexandrovska EAD Sofia
Croatia General Hospital Sibenik Šibenik
Croatia KBC Split Split
Croatia CHC Sestre milosrdnice Zagreb
Czechia Faculty Hospital by St. Anna Brno Brno
France Hospital A Michallon, CHU Grenoble La Tronche
Germany Charite Universitatsmedizin Berlin Berlin
Hungary Semmelweis University, 3rd Department of Internal Medicine Budapest
Italy Ospedale Luigi Sacco Milan
North Macedonia PHI University Clinic of Dermatology Skopje
Norway Alesund Hospital Alesund
Norway Stavanger University Hospital Stavanger
Poland University Hospital Krakow Krakow
Slovakia Bratislava University Hospital Bratislava
Slovakia University Hospital Martin Martin
Slovenia University Clinic Golnik Golnik
Sweden Ryhof County Hospital Jonkoping

Sponsors (1)
Lead Sponsor Collaborator
Pharming Technologies B.V.

Countries where clinical trial is conducted

Bulgaria,  Croatia,  Czechia,  France,  Germany,  Hungary,  Italy,  North Macedonia,  Norway,  Poland,  Slovakia,  Slovenia,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary objective is to observe the adverse event profile and insufficient efficacy, following single and repeated treatment with Ruconest or pdC1INH of acute angioedema attacks December 2019
Secondary To assess the immunological profile of Ruconest (for suspected hypersensitivity or suspected neutralizing antibodies) December 2019
See also
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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 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
Recruiting NCT05511922 - PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial Phase 3
Not yet recruiting NCT02159430 - Hereditary AngioEdema, Neurobiology and Psychopathology N/A
Completed NCT02303626 - 12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks Phase 2/Phase 3
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