Hereditary Angioedema Type I or II
Conditions
Interventions
Product Name: KVD900 100 mg Film Coated Tablet
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: None
Current Sponsor code: KVD900
Sponsors
KalVista Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female adult subjects 18 years of age and older. 2. Confirmed diagnosis of HAE type I or II at anytime in the medical history 3. At least 3 documented HAE attacks in the past 93 days, as supported by medical history. 4. Access to and ability to use conventional attack treatment for attacks of HAE. 5. Adequate organ functions as defined below: a. Hemoglobin within normal range; b. International normalized ratio (INR)=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Any concomitant diagnosis of another form of chronic angioedema. 2. Current use of C1INH, androgens, lanadelumab or tranexamic acid for HAE prophylaxis. 3. Use of angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption within 90 days prior to initial study treatment. 4. Use of androgens or antifibrinolytics within 30 days prior to initial study treatment. 5. Use of lanadelumabwihtin 10 weeks to prior to initial study treatment. 6. Use of strong CYP3A4/CYP2C9 inhibitors and inducers during participation in the trial. 7. Clinically significant abnormal electrocardiogram (ECG) at Visit 1 and pre-dose at Visit 2. 8. Any clinically significant history of angina, myocardial infarction, syncope, clinically significant cardiac arrhythmias, left ventricular hypertrophy, cardiomyopathy, or any other cardiovascular abnormality. 9. Any other systemic dysfunction (e.g., gastrointestinal, renal, respiratory, cardiovascular) or significant disease or disorder which, in the opinion of the Investigator, would jeopardize the safety of the subject by taking part in the trial. 10. History of substance abuse or dependence that would interfere with the completion of the study, as determined by the Investigator. 11. Known lactose allergy or intolerance. 12. Known hypersensitivity to KVD900 or placebo or to any of the excipients. 13. Participation in an interventional investigational clinical study within 3 months or within 5 half-lives of the last dosing of investigational drug (whichever is longer) prior to initial study treatment. 14. Any pregnant or breast-feeding subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of KVD900 compared to placebo in halting the progression of attacks of HAE. ; Secondary Objective: To investigate the safety and tolerability of KVD900 To investigate the pharmacokinetic (PK) profile of KVD900 To investigate the pharmacodynamic (PD) profile of KVD900 ; Primary end point(s): Primary Efficacy Endpoints: • Time to use of conventional attack treatment. ;Timepoint(s) of evaluation of this end point: 12 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 12 hours; Secondary end point(s): Secondary Efficacy Endpoints: • Proportion of HAE attacks that progress by one level or more on the 5LS or that require conventional attack treatment within 12h of study drug. • Time between treatment and (1) progression of global attack severity on the 5LS by one level or more, or (2) use of conventional attack treatment, whichever comes first within 12h | — |
Countries
Austria, Germany, Hungary, Macedonia, the former Yugoslav Republic of, Netherlands, United Kingdom, United States
Contacts
Public ContactRegulatory Affairs Department
Orion Clinical Services Limited
Outcome results
None listed