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

Phase 3

• Conditions: Hereditary Angioedema; blood disease; 10064477

• Registration Number: NL-OMON56365
• Lead Sponsor: KalVista Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

Patients may roll over from KVD900-301.
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.
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 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 (e.g., stanozolol, danazol,
oxandrolone, methyltestosterone, testosterone), or anti-fibrinolytics (e.g.,
tranexamic acid) within 28 days prior to the Enrollment Visit. 6) Use of 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: a) Alanine aminotransferase (ALT) >2x ULN b)
Aspartate aminotransferase (AST) >2x ULN c) Bilirubin direct >1.25x ULN d) INR
>1.2 e) 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified