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

NCT05511922 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: KVD900-302a
• Study Type: interventional
• Target: 11
• Locations: 16 countries
• Sites: 60

Brief Summary

This is a multicenter pharmacokinetic (PK) subtrial to investigate the PK profile of KVD900 (sebetralstat) in adolescent patients 12 to 17 years of age with Hereditary Angioedema (HAE) type I or II.

Conditions

Hereditary Angioedema

Keywords

KONFIDENT-S; Sebetralstat

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics - Cmax

  Up to 6 hours after IMP administration

• Pharmacokinetics - Tmax

  Up to 6 hours after IMP administration

• Pharmacokinetics - AUC

  Up to 6 hours after IMP administration

Study Arms (2)

KVD900 600 mg

EXPERIMENTAL

Drug: KVD900 600 mg

Experimental: KVD900 300 mg

EXPERIMENTAL

Drug: Drug: KVD900 300 mg

Interventions

KVD900 600 mg DRUG

KVD900 Tablet 600 mg (2 x 300 mg)

KVD900 600 mg

Drug: KVD900 300 mg DRUG

KVD900 Tablet 300 mg

Experimental: KVD900 300 mg

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Patient has a history of any bleeding disorder or currently taking any anti-coagulant or anti-platelet agent.

Sponsors & Collaborators

• KalVista Pharmaceuticals, Ltd.: lead

Study Sites (61)

KalVista Investigative Site

Scottsdale, Arizona, 85251, United States

Location

KalVista Investigative Site

Little Rock, Arkansas, 72205, United States

Location

KalVista Investigative Site

San Diego, California, 92122, United States

Location

KalVista Investigative Site

San Diego, California, 92123, United States

Location

KalVista Investigative Site

Santa Monica, California, 90404, United States

Location

KalVista Investigative Site

Centennial, Colorado, 80112, United States

Location

KalVista Investigative Site

Colorado Springs, Colorado, 80907, United States

Location

KalVista Investigative Site

Evansville, Indiana, 47715, United States

Location

KalVista Investigative Site

Overland Park, Kansas, 66211, United States

Location

KalVista Investigative Site

Louisville, Kentucky, 40215, United States

Location

KalVista Investigative Site

Chevy Chase, Maryland, 20815, United States

Location

KalVista Investigative Site

Plymouth, Minnesota, 55446, United States

Location

KalVista Investigative Site

St Louis, Missouri, 63141, United States

Location

KalVista Investigative Site

Charlotte, North Carolina, 28277, United States

Location

KalVista Investigative Site

Cincinnati, Ohio, 45236, United States

Location

KalVista Investigative Site

Toledo, Ohio, 43617, United States

Location

Kalvista Investigative Site

Hershey, Pennsylvania, 17033, United States

Location

KalVista Investigative Site

Dallas, Texas, 75231, United States

Location

KalVista Investigative Site

Layton, Utah, 84041, United States

Location

KalVista Investigative Site

Spokane, Washington, 99204, United States

Location

KalVista Investigative Site

Campbelltown, 2560, Australia

Location

KalVista Investigative Site

Vienna, 1090, Austria

Location

KalVista Investigative Site

Sofia, 1431, Bulgaria

Location

KalVista Investigative Site

Montreal, H2W 1R7, Canada

Location

KalVista Investigative Site

Grenoble, 38043, France

Location

KalVista Investigative Site

Lille, 59037, France

Location

KalVista Investigative Site

Paris, 75012, France

Location

KalVista Investigative Site

Berlin, 12203, Germany

Location

KalVista Investigative Site

Frankfurt, 60590, Germany

Location

KalVista Investigative Site

Mainz, 55131, Germany

Location

KalVista Investigative Site

Mörfelden-Walldorf, 64546, Germany

Location

KalVista Investigative Site

Athens, 11521, Greece

Location

KalVista Investigative Site

Athens, 11527, Greece

Location

KalVista Investigative Site

Haifa, 31048, Israel

Location

KalVista Investigative Site

Petach Tikvah, 4920235, Israel

Location

KalVista Investigative Site

Ramat Gan, 52621, Israel

Location

KalVista Investigative Site

Tel Aviv, 64239, Israel

Location

KalVista Investigative Site

Sapporo, Hokkaido, 002-8072, Japan

Location

KalVista Investigative Site

Chiba, 260-8677, Japan

Location

KalVista Investigative Site

Hiroshima, 730-8518, Japan

Location

KalVista Investigative Site

Kawagoe-shi, 350-8550, Japan

Location

KalVista Investigative Site

Maebashi, 371-8511, Japan

Location

KalVista Investigative Site

Soka-shi, 340-0041, Japan

Location

KalVista Investigative Site

Takatsuki-shi, 569-8686, Japan

Location

KalVista Investigative Site

Tokyo, 142-8666, Japan

Location

KalVista Investigative Site

Yokohama, 236-0004, Japan

Location

KalVista Investigative Site

Amsterdam, 1105 AZ, Netherlands

Location

KalVista Investgative Site

Auckland, 1023, New Zealand

Location

KalVista Investigative Site

Sângeorgiu de Mureş, 547530, Romania

Location

KalVista Investigative Site

Martin, 036 59, Slovakia

Location

KalVista Investigative Site

Cape Town, 7700, South Africa

Location

KalVista Investigative Site

Barcelona, 08035, Spain

Location

KalVista Investigative Site

Barcelona, 08907, Spain

Location

KalVista Investigative Site

Madrid, 28046, Spain

Location

KalVista Investigative Site

Birmingham, B9 5SS, United Kingdom

Location

KalVista Investigative Site

Cambridge, CB2 0QQ, United Kingdom

Location

KalVista Investigative Site

Cardiff, CF14 4XW, United Kingdom

Location

KalVista Investgative Site

Frimley, GU16 7UJ, United Kingdom

Location

KalVista Investigative Site

Leeds, LS9 7TF, United Kingdom

Location

KalVista Investigative Site

London, E1 2ES, United Kingdom

Location

KalVista Investigative Site

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Angioedemas, Hereditary

Interventions

sebetralstat

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Study Officials

• Study Director

  KalVista Pharmaceuticals, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 23, 2022
• Study Start: October 24, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); US (20); AU (1); ZA (1); DE (4); JP (9); GB (7); IL (4); NL (1); BU (1); FR (3); NZ (1); GR (2); RO (1); SL (1); CA (1)