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PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial

Primary Purpose

Hereditary Angioedema

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
KVD900 600 mg
Sponsored by
KalVista Pharmaceuticals, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hereditary Angioedema focused on measuring KONFIDENT-S

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • KalVista Investigative SiteRecruiting
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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

KVD900 600 mg

Arm Description

Outcomes

Primary Outcome Measures

Pharmacokinetics - Cmax
Pharmacokinetics - Tmax
Pharmacokinetics - AUC

Secondary Outcome Measures

Full Information

First Posted
August 11, 2022
Last Updated
September 29, 2023
Sponsor
KalVista Pharmaceuticals, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05511922
Brief Title
PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial
Official Title
A Pharmacokinetic Subtrial in Adolescent Patients With Hereditary Angioedema Type I or II Participating in the KVD900-302 Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2022 (Actual)
Primary Completion Date
January 30, 2026 (Anticipated)
Study Completion Date
January 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KalVista Pharmaceuticals, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Angioedema
Keywords
KONFIDENT-S

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KVD900 600 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KVD900 600 mg
Intervention Description
KVD900 Tablet 600 mg (2 x 300 mg)
Primary Outcome Measure Information:
Title
Pharmacokinetics - Cmax
Time Frame
Up to 6 hours after IMP administration
Title
Pharmacokinetics - Tmax
Time Frame
Up to 6 hours after IMP administration
Title
Pharmacokinetics - AUC
Time Frame
Up to 6 hours after IMP administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
KalVista Pharmaceuticals
Phone
1 (857) 999-0075
Email
clinicalstudies@kalvista.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
KalVista Pharmaceuticals, Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
KalVista Investigative Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47715
Country
United States
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40215
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
KalVista Investigative Site
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
KalVista Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Individual Site Status
Recruiting
Facility Name
Kalvista Investigative Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Campbelltown
ZIP/Postal Code
2560
Country
Australia
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Grenoble Cedex 9
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Morfelden-Walldorf
ZIP/Postal Code
64546
Country
Germany
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Athens
ZIP/Postal Code
11521
Country
Greece
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Petach Tikvah
ZIP/Postal Code
4920235
Country
Israel
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Chiba-shi
ZIP/Postal Code
260-8677
Country
Japan
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Hiroshima-shi
ZIP/Postal Code
730-8518
Country
Japan
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Kawagoe-shi
ZIP/Postal Code
350-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Maebashi-city
ZIP/Postal Code
371-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Soka-shi
ZIP/Postal Code
340-0041
Country
Japan
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Takatsuki-shi
ZIP/Postal Code
569-8686
Country
Japan
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Yokohama-shi
ZIP/Postal Code
236-0004
Country
Japan
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
KalVista Investgative Site
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
KalVista Investigative Site
City
London
ZIP/Postal Code
E1 2ES
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will not be shared until all global regulatory filings are complete.

Learn more about this trial

PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial

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