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)

  • STATUS
    Recruiting
  • End date
    Jan 30, 2026
  • participants needed
    150
  • sponsor
    KalVista Pharmaceuticals, Ltd.
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Updated on 11 September 2023
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angioedema

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.

Details
Condition Hereditary Angioedema
Treatment KVD900 600 mg
Clinical Study IdentifierNCT05505916
SponsorKalVista Pharmaceuticals, Ltd.
Last Modified on11 September 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

Confirmed diagnosis of HAE type I or II at any time in the medical history
Patient has had at least 2 documented HAE attacks within 3 months prior to the Enrollment Visit
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 6 months prior to the Enrollment Visit
Male or female patients 12 years of age and older
Patients must meet the contraception requirements
Patients must be able to swallow trial tablets whole
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
Investigator believes that the patient is willing and able to adhere to all protocol requirements
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

Discontinued from the KVD900-301 trial for reasons of noncompliance, withdrawal of consent, or safety
Presence of any safety concerns that would preclude participation in the open-label trial as determined by the investigator
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
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
Use of attenuated androgens (e.g., stanozolol, danazol, oxandrolone, methyltestosterone, testosterone), or anti-fibrinolytics (e.g., tranexamicacid) within 28 days prior to the Enrollment Visit
Use of Angiotensin-converting enzyme (ACE) inhibitors within 7 days prior to the Enrollment Visit
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
Inadequate organ function, including but not limited to
Alanine aminotransferase (ALT) >2x Upper Limit Normal (ULN)
Aspartate aminotransferase (AST) >2x ULN
Bilirubin direct >1.25x ULN
International Normalized Ratio (INR) >1.2
Clinically significant hepatic impairment defined as a Child-Pugh B or C
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
History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator
Known hypersensitivity to KVD900 or to any of the excipients
Participation in any gene therapy treatment or trial for HAE
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
Any pregnant or breastfeeding patient
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