- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05511922
PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial
March 6, 2024 updated by: KalVista Pharmaceuticals, Ltd.
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.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
12
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: KalVista Pharmaceuticals
- Phone Number: 1 (857) 999-0075
- Email: clinicalstudies@kalvista.com
Study Locations
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Campbelltown, Australia, 2560
- Recruiting
- KalVista Investigative Site
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Wien, Austria, 1090
- Recruiting
- KalVista Investigative Site
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Sofia, Bulgaria, 1431
- Recruiting
- KalVista Investigative Site
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Montréal, Canada, H2W 1R7
- Recruiting
- KalVista Investigative Site
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Grenoble Cedex 9, France, 38043
- Recruiting
- KalVista Investigative Site
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Lille, France, 59037
- Recruiting
- KalVista Investigative Site
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Lille Cedex, France, 59037
- Recruiting
- KalVista Investigative Site
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Paris, France, 75012
- Recruiting
- KalVista Investigative Site
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Berlin, Germany, 12203
- Recruiting
- KalVista Investigative Site
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Frankfurt, Germany, 60590
- Recruiting
- KalVista Investigative Site
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Mainz, Germany, 55131
- Recruiting
- KalVista Investigative Site
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Morfelden-Walldorf, Germany, 64546
- Recruiting
- KalVista Investigative Site
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Athens, Greece, 11521
- Recruiting
- KalVista Investigative Site
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Athens, Greece, 11527
- Recruiting
- KalVista Investigative Site
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Haifa, Israel, 31048
- Recruiting
- KalVista Investigative Site
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Petach Tikvah, Israel, 4920235
- Recruiting
- KalVista Investigative Site
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Ramat Gan, Israel, 52621
- Recruiting
- KalVista Investigative Site
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Tel Aviv, Israel, 64239
- Recruiting
- KalVista Investigative Site
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Chiba-shi, Japan, 260-8677
- Active, not recruiting
- KalVista Investigative Site
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Hiroshima-shi, Japan, 730-8518
- Active, not recruiting
- KalVista Investigative Site
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Kawagoe-shi, Japan, 350-8550
- Active, not recruiting
- KalVista Investigative Site
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Maebashi-city, Japan, 371-8511
- Active, not recruiting
- KalVista Investigative Site
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Soka-shi, Japan, 340-0041
- Active, not recruiting
- KalVista Investigative Site
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Takatsuki-shi, Japan, 569-8686
- Active, not recruiting
- KalVista Investigative Site
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Tokyo, Japan, 142-8666
- Active, not recruiting
- KalVista Investigative Site
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Yokohama-shi, Japan, 236-0004
- Active, not recruiting
- KalVista Investigative Site
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Hokkaido
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Sapporo-city, Hokkaido, Japan, 002-8072
- Active, not recruiting
- KalVista Investigative Site
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Amsterdam, Netherlands, 1105 AZ
- Recruiting
- KalVista Investigative Site
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Auckland, New Zealand, 1023
- Recruiting
- KalVista Investgative Site
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Sângeorgiu De Mureş, Romania, 547530
- Recruiting
- KalVista Investigative Site
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Martin, Slovakia, 036 59
- Recruiting
- KalVista Investigative Site
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Cape Town, South Africa, 7700
- Recruiting
- KalVista Investigative Site
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Barcelona, Spain, 08035
- Recruiting
- KalVista Investigative Site
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Barcelona, Spain, 08907
- Recruiting
- KalVista Investigative Site
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Madrid, Spain, 28046
- Recruiting
- KalVista Investigative Site
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Birmingham, United Kingdom, B9 5SS
- Recruiting
- KalVista Investigative Site
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Cambridge, United Kingdom, CB2 0QQ
- Recruiting
- KalVista Investigative Site
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Cardiff, United Kingdom, CF14 4XW
- Recruiting
- KalVista Investigative Site
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Frimley, United Kingdom, GU16 7UJ
- Recruiting
- KalVista Investgative Site
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Leeds, United Kingdom, LS9 7TF
- Recruiting
- KalVista Investigative Site
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London, United Kingdom, E1 2ES
- Recruiting
- KalVista Investigative Site
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London, United Kingdom, NW3 2QG
- Recruiting
- KalVista Investigative Site
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Arizona
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Scottsdale, Arizona, United States, 85251
- Recruiting
- KalVista Investigative Site
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Recruiting
- KalVista Investigative Site
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California
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San Diego, California, United States, 92122
- Recruiting
- KalVista Investigative Site
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San Diego, California, United States, 92123
- Recruiting
- KalVista Investigative Site
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Santa Monica, California, United States, 90404
- Recruiting
- KalVista Investigative Site
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Colorado
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Centennial, Colorado, United States, 80112
- Active, not recruiting
- KalVista Investigative Site
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Colorado Springs, Colorado, United States, 80907
- Recruiting
- KalVista Investigative Site
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Indiana
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Evansville, Indiana, United States, 47715
- Recruiting
- KalVista Investigative Site
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Kansas
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Overland Park, Kansas, United States, 66211
- Recruiting
- KalVista Investigative Site
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Kentucky
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Louisville, Kentucky, United States, 40215
- Completed
- KalVista Investigative Site
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Maryland
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Chevy Chase, Maryland, United States, 20815
- Recruiting
- KalVista Investigative Site
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Minnesota
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Plymouth, Minnesota, United States, 55446
- Recruiting
- KalVista Investigative Site
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Missouri
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Saint Louis, Missouri, United States, 63141
- Recruiting
- KalVista Investigative Site
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North Carolina
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Charlotte, North Carolina, United States, 28277
- Active, not recruiting
- KalVista Investigative Site
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Ohio
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Cincinnati, Ohio, United States, 45236
- Recruiting
- KalVista Investigative Site
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Toledo, Ohio, United States, 43617
- Recruiting
- KalVista Investigative Site
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Recruiting
- KalVista Investigative Site
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Texas
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Dallas, Texas, United States, 75231
- Recruiting
- KalVista Investigative Site
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Utah
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Layton, Utah, United States, 84041
- Recruiting
- KalVista Investigative Site
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Washington
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Spokane, Washington, United States, 99204
- Recruiting
- KalVista Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: KVD900 600 mg
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KVD900 Tablet 600 mg (2 x 300 mg)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Pharmacokinetics - Cmax
Time Frame: Up to 6 hours after IMP administration
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Up to 6 hours after IMP administration
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Pharmacokinetics - Tmax
Time Frame: Up to 6 hours after IMP administration
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Up to 6 hours after IMP administration
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Pharmacokinetics - AUC
Time Frame: Up to 6 hours after IMP administration
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Up to 6 hours after IMP administration
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Study Director, KalVista Pharmaceuticals, Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 24, 2022
Primary Completion (Estimated)
January 30, 2026
Study Completion (Estimated)
January 30, 2026
Study Registration Dates
First Submitted
August 11, 2022
First Submitted That Met QC Criteria
August 19, 2022
First Posted (Actual)
August 23, 2022
Study Record Updates
Last Update Posted (Actual)
March 7, 2024
Last Update Submitted That Met QC Criteria
March 6, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Hypersensitivity, Immediate
- Genetic Diseases, Inborn
- Skin Diseases, Vascular
- Hypersensitivity
- Urticaria
- Hereditary Complement Deficiency Diseases
- Primary Immunodeficiency Diseases
- Angioedema
- Angioedemas, Hereditary
Other Study ID Numbers
- KVD900-302a
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data will not be shared until all global regulatory filings are complete.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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