Hereditary Angioedema Clinical Trial
Official title:
A Pharmacokinetic Subtrial in Adolescent Patients With Hereditary Angioedema Type I or II Participating in the KVD900-302 Trial
This is a multicenter pharmacokinetic (PK) subtrial to investigate the PK profile of KVD900 in adolescent patients 12 to 17 years of age with Hereditary Angioedema (HAE) type I or II.
| Status | Recruiting |
| Enrollment | 12 |
| Est. completion date | January 30, 2026 |
| Est. primary completion date | January 30, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years to 17 Years |
| Eligibility | Inclusion Criteria: - Male or female adolescent patient 12 to 17 years of age at the time of enrollment and during sample collection in this PK subtrial. - Patient is currently participating in KVD900-302. - Patient must provide signed informed consent or assent (when applicable), and a legally authorized representative (LAR) must also provide signed informed consent when applicable. - Patient and LAR are willing and able to provide samples per the requirements of the protocol, including willingness to complete forms and the electronic Diary, obtain and return samples in a timely manner, and obtain samples while within the required age limit. Exclusion Criteria: - Patient has a history of any bleeding disorder or currently taking any anti-coagulant or anti-platelet agent. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | KalVista Investigative Site | Campbelltown | |
| Austria | KalVista Investigative Site | Wien | |
| Bulgaria | KalVista Investigative Site | Sofia | |
| Canada | KalVista Investigative Site | Montréal | |
| France | KalVista Investigative Site | Grenoble Cedex 9 | |
| France | KalVista Investigative Site | Lille | |
| France | KalVista Investigative Site | Lille Cedex | |
| France | KalVista Investigative Site | Paris | |
| Germany | KalVista Investigative Site | Berlin | |
| Germany | KalVista Investigative Site | Frankfurt | |
| Germany | KalVista Investigative Site | Mainz | |
| Germany | KalVista Investigative Site | Morfelden-Walldorf | |
| Greece | KalVista Investigative Site | Athens | |
| Greece | KalVista Investigative Site | Athens | |
| Israel | KalVista Investigative Site | Haifa | |
| Israel | KalVista Investigative Site | Petach Tikvah | |
| Israel | KalVista Investigative Site | Ramat Gan | |
| Israel | KalVista Investigative Site | Tel Aviv | |
| Japan | KalVista Investigative Site | Chiba-shi | |
| Japan | KalVista Investigative Site | Hiroshima-shi | |
| Japan | KalVista Investigative Site | Kawagoe-shi | |
| Japan | KalVista Investigative Site | Maebashi-city | |
| Japan | KalVista Investigative Site | Sapporo-city | Hokkaido |
| Japan | KalVista Investigative Site | Soka-shi | |
| Japan | KalVista Investigative Site | Takatsuki-shi | |
| Japan | KalVista Investigative Site | Tokyo | |
| Japan | KalVista Investigative Site | Yokohama-shi | |
| Netherlands | KalVista Investigative Site | Amsterdam | |
| New Zealand | KalVista Investgative Site | Auckland | |
| Romania | KalVista Investigative Site | Sângeorgiu De Mures | |
| Slovakia | KalVista Investigative Site | Martin | |
| South Africa | KalVista Investigative Site | Cape Town | |
| Spain | KalVista Investigative Site | Barcelona | |
| Spain | KalVista Investigative Site | Barcelona | |
| Spain | KalVista Investigative Site | Madrid | |
| United Kingdom | KalVista Investigative Site | Birmingham | |
| United Kingdom | KalVista Investigative Site | Cambridge | |
| United Kingdom | KalVista Investigative Site | Cardiff | |
| United Kingdom | KalVista Investgative Site | Frimley | |
| United Kingdom | KalVista Investigative Site | Leeds | |
| United Kingdom | KalVista Investigative Site | London | |
| United Kingdom | KalVista Investigative Site | London | |
| United States | KalVista Investigative Site | Centennial | Colorado |
| United States | KalVista Investigative Site | Charlotte | North Carolina |
| United States | KalVista Investigative Site | Chevy Chase | Maryland |
| United States | KalVista Investigative Site | Cincinnati | Ohio |
| United States | KalVista Investigative Site | Colorado Springs | Colorado |
| United States | KalVista Investigative Site | Dallas | Texas |
| United States | KalVista Investigative Site | Evansville | Indiana |
| United States | Kalvista Investigative Site | Hershey | Pennsylvania |
| United States | KalVista Investigative Site | Layton | Utah |
| United States | KalVista Investigative Site | Little Rock | Arkansas |
| United States | KalVista Investigative Site | Louisville | Kentucky |
| United States | KalVista Investigative Site | Overland Park | Kansas |
| United States | KalVista Investigative Site | Plymouth | Minnesota |
| United States | KalVista Investigative Site | Saint Louis | Missouri |
| United States | KalVista Investigative Site | San Diego | California |
| United States | KalVista Investigative Site | San Diego | California |
| United States | KalVista Investigative Site | Santa Monica | California |
| United States | KalVista Investigative Site | Scottsdale | Arizona |
| United States | KalVista Investigative Site | Spokane | Washington |
| United States | KalVista Investigative Site | Toledo | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| KalVista Pharmaceuticals, Ltd. |
United States, Australia, Austria, Bulgaria, Canada, France, Germany, Greece, Israel, Japan, Netherlands, New Zealand, Romania, Slovakia, South Africa, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pharmacokinetics - Cmax | Up to 6 hours after IMP administration | ||
| Primary | Pharmacokinetics - Tmax | Up to 6 hours after IMP administration | ||
| Primary | Pharmacokinetics - AUC | Up to 6 hours after IMP 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 |
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 | |
| Completed |
NCT01679912 -
A Call Center During HAE Attacks (SOS HAE)
|
Phase 4 |