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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05505916




Registration number
NCT05505916
Ethics application status
Date submitted
11/08/2022
Date registered
18/08/2022

Titles & IDs
Public title
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)
Scientific 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
Secondary ID [1] 0 0
KVD900-302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hereditary Angioedema 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KVD900 600 mg

Experimental: KVD900 600 mg -


Treatment: Drugs: KVD900 600 mg
KVD900 Tablet 600 mg (2 x 300 mg)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequencies and percentages of patients with AEs, AEs within 2 days of IMP administration, serious AE's and AEs causing premature discontinuation.
Timepoint [1] 0 0
AEs will be recorded from the first dose of IMP in the KVD900-302 trial up to and including the end of study (EOS) visit, a maximum of 2 years for each patient.
Primary outcome [2] 0 0
Number and percentage of patients with normal or abnormal laboratory results at each scheduled visit.
Timepoint [2] 0 0
Throughout the duration of the trial.
Primary outcome [3] 0 0
Number and percentage of patients with normal or abnormal vital sign results at each scheduled visit
Timepoint [3] 0 0
Throughout the duration of the trial.
Secondary outcome [1] 0 0
Patient Global Impression of Change (PGI-C).
Timepoint [1] 0 0
within 12 hours of initial dose of IMP administration.
Secondary outcome [2] 0 0
Patient Global Impression of Severity (PGI-S): time to first incidence of 2 time points in a row decrease from baseline
Timepoint [2] 0 0
within 12 hours of initial dose of IMP administration.
Secondary outcome [3] 0 0
PGI-S: time to HAE attack resolution
Timepoint [3] 0 0
within 24 hours of initial dose of IMP administration.

Eligibility
Key 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 (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.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
Accrual to date
Final
145
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
KalVista Investigative Site - Campbelltown
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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Arkansas
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California
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Colorado
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Indiana
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Kansas
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Kentucky
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Maryland
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Minnesota
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Missouri
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North Carolina
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Ohio
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Pennsylvania
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Texas
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Utah
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United States of America
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Washington
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Austria
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Wein
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Bulgaria
State/province [18] 0 0
Sofia
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Canada
State/province [19] 0 0
Montréal
Country [20] 0 0
France
State/province [20] 0 0
Grenoble Cedex 9
Country [21] 0 0
France
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Lille Cedex
Country [22] 0 0
France
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Lille
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France
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Paris
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Germany
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Berlin
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Germany
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Frankfurt
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Germany
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Mainz
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Germany
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Morfelden-Walldorf
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Greece
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Athens
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Hungary
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Budapest
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Israel
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Haifa
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Israel
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Petach Tikvah
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Padova
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Italy
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Palermo
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Italy
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Roma
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Italy
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San Donato Milanese
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Japan
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Hokkaido
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Japan
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Chiba-shi
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Japan
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Hiroshima-shi
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Japan
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Kawagoe-shi
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Japan
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Maebashi-city
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Japan
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Soka-shi
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Japan
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Takatsuki-shi
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Japan
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Tokyo
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Japan
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Yokohama-shi
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Netherlands
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Amsterdam
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New Zealand
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Auckland
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North Macedonia
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Skopje
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Poland
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Kraków
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Poland
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Lódz
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Portugal
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Porto
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Romania
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Sângeorgiu De Mures
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Saudi Arabia
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Riyadh
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Slovakia
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Martin
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South Africa
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Cape Town
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Spain
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Barcelona
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Spain
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Madrid
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United Kingdom
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Birmingham
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United Kingdom
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Cambridge
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United Kingdom
State/province [61] 0 0
Cardiff
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United Kingdom
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Frimley
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United Kingdom
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Leeds
Country [64] 0 0
United Kingdom
State/province [64] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
KalVista Pharmaceuticals, Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
KalVista Pharmaceuticals, Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
KalVista Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1 (857) 999-0075
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will not be shared until all global regulatory filings are complete.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05505916