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ACTIVE NOT RECRUITING

NCT05505916

PHASE3

An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)

Sponsor: KalVista Pharmaceuticals, Ltd.

View on ClinicalTrials.gov

Summary

This is an open-label, multicenter extension trial to evaluate the long-term safety of KVD900 in patients who are 12 years or older with HAE type I or II.

Official title: An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema Type I or II

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

145

Start Date

2022-10-24

Completion Date

2026-06-30

Last Updated

2026-02-18

Healthy Volunteers

Conditions

Hereditary Angioedema

Interventions

DRUG

KVD900 600 mg

KVD900 Tablet 600 mg (2 x 300 mg)

DRUG

KVD900 300 mg

KVD900 Tablet 300 mg

Patients may roll over from KVD900-301. Inclusion Criteria: 1. Confirmed diagnosis of HAE type I or II at any time in the medical history 2. Patient has had at least 2 documented HAE attacks within 3 months prior to the Enrollment Visit. 3. If a patient is receiving long-term prophylactic treatment with one of the protocol-allowed therapies, they must have been on a stable dose and regimen for at least 3 months prior to the Enrollment Visit (except for danazol, which requires a stable dose and regimen for at least 6 months prior to the Enrollment Visit). 4. Male or female patients 12 years of age and older. 5. Patients must meet the contraception requirements. 6. Patients must be able to swallow trial tablets whole. 7. Patients, as assessed by the Investigator, must be able to appropriately receive and store IMP, and be able to read, understand, and complete the eDiary. 8. Investigator believes that the patient is willing and able to adhere to all protocol requirements. 9. Patient provides signed informed consent or assent (when applicable). A parent or legally authorized representative (LAR) must also provide signed informed consent when required. Exclusion Criteria: 1. Discontinued from the KVD900-301 trial for reasons of noncompliance, withdrawal of consent, or safety. 2. Presence of any safety concerns that would preclude participation in the open-label trial as determined by the investigator. 3. Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (previously known as HAE type III), idiopathic angioedema, or angioedema associated with urticaria. 4. A clinically significant history of poor response to bradykinin receptor 2 (BR2) blocker, C1-INH therapy, or plasma kallikrein inhibitor therapy for the management of HAE, in the opinion of the Investigator. 5. Use of attenuated androgens other than danazol (e.g., stanozolol, oxandrolone, methyltestosterone, testosterone), or anti-fibrinolytics (e.g., tranexamicacid) within 28 days prior to the Enrollment Visit. 6. Use of Angiotensin-converting enzyme (ACE) inhibitors within 7 days prior to the Enrollment Visit. 7. Any estrogen-containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) within 7 days prior to the Enrollment Visit. 8. Inadequate organ function, including but not limited to: 1. Alanine aminotransferase (ALT) \>2x Upper Limit Normal (ULN) 2. Aspartate aminotransferase (AST) \>2x ULN 3. Bilirubin direct \>1.25x ULN 4. International Normalized Ratio (INR) \>1.2 5. Clinically significant hepatic impairment defined as a Child-Pugh B or C 9. Any clinically significant comorbidity or systemic dysfunction, which in the opinion of the Investigator, would jeopardize the safety of the patient by participating in the trial. 10. History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator. 11. Known hypersensitivity to KVD900 or to any of the excipients. 12. Participation in any gene therapy treatment or trial for HAE. 13. Participation in any interventional investigational clinical trial, including an investigational COVID-19 vaccine trial, within 4 weeks of the last dosing of investigational drug prior to the Enrollment Visit. 14. Any pregnant or breastfeeding patient.

Locations (71)

KalVista Investigative Site

Scottsdale, Arizona, United States

KalVista Investigative Site

Little Rock, Arkansas, 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

Centennial, Colorado, United States

KalVista Investigative Site

Colorado Springs, Colorado, United States

KalVista Investigative Site

Evansville, Indiana, United States

KalVista Investigative Site

Overland Park, Kansas, United States

KalVista Investigative Site

Louisville, Kentucky, United States

KalVista Investigative Site

Chevy Chase, Maryland, United States

KalVista Investigative Site

Plymouth, Minnesota, United States

KalVista Investigative Site

St Louis, Missouri, United States

KalVista Investigative Site

Charlotte, North Carolina, United States

KalVista Investigative Site

Cincinnati, Ohio, United States

KalVista Investigative Site

Toledo, Ohio, United States

KalVista Investigative Site

Hershey, Pennsylvania, United States

KalVista Investigative Site

Dallas, Texas, United States

KalVista Investgative Site

Layton, Utah, United States

KalVista Investigative Site

Spokane, Washington, United States

KalVista Investigative Site

Campbelltown, Australia

KalVista Investigative Site

Wein, Austria

KalVista Investigative Site

Sofia, Bulgaria

KalVista Investigative Site

Montreal, Canada

KalVista Investigative Site

Grenoble, France

KalVista Investigative Site

Lille, France

KalVista Investigative Site

Paris, France

KalVista Investigative Site

Berlin, Germany

KalVista Investigative Site

Frankfurt, Germany

KalVista Investigative Site

Mainz, Germany

KalVista Investigative Site

Mörfelden-Walldorf, Germany

KalVista Investigative Site

Athens, Greece

KalVista Investigative Site

Athens, Greece

KalVista Investigative Site

Budapest, Hungary

KalVista Investigative Site

Haifa, Israel

KalVista Investigative Site

Petach Tikvah, Israel

KalVista Investigative Site

Ramat Gan, Israel

KalVista Investigative Site

Tel Aviv, Israel

KalVista Investigative Site

Padova, Italy

KalVista Investigative Site

Palermo, Italy

KalVista Investigative Site

Roma, Italy

KalVista Investigative Site

San Donato Milanese, Italy

KalVista Investigative Site

Sapporo, Hokkaido, Japan

KalVista Investigative Site

Chiba, Japan

KalVista Investigative Site

Hiroshima, Japan

KalVista Investigative Site

Kawagoe-shi, Japan

KalVista Investigative Site

Maebashi, Japan

KalVista Investigative Site

Soka-shi, Japan

KalVista Investigative Site

Takatsuki-shi, Japan

KalVista Investgative Site

Tokyo, Japan

KalVista Investigative Site

Yokohama, Japan

KalVista Investigative Site

Amsterdam, Netherlands

KalVista Investigative Site

Auckland, New Zealand

KalVista Investigative Site

Skopje, North Macedonia

KalVista Investigative Site

Krakow, Poland

KalVista Investigative Site

Lodz, Poland

KalVista Investigative Site

Porto, Portugal

KalVista Investigative Site

Sângeorgiu de Mureş, Romania

KalVista Investigative Site

Riyadh, Saudi Arabia

KalVista Investigative Site

Martin, Slovakia

Kalvista Investigative Site

Cape Town, South Africa

KalVista Investigative Site

Barcelona, Spain

KalVista Investigative Site

Barcelona, Spain

KalVista Investigative Site

Madrid, Spain

KalVista Investigative Site

Birmingham, United Kingdom

KalVista Investigative Site

Cambridge, United Kingdom

KalVista Investigative Site

Cardiff, United Kingdom

KalVista Investigative Site

Frimley, United Kingdom

KalVista Investigative Site

Leeds, United Kingdom

KalVista Investigative Site

London, United Kingdom

KalVista Investigative Site

London, United Kingdom

Clinical Research Directory

An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (71)