Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05505916




Registration number
NCT05505916
Ethics application status
Date submitted
11/08/2022
Date registered
18/08/2022
Date last updated
7/03/2024

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
N/A
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
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
30/01/2026
Actual
Sample size
Target
150
Accrual to date
Final
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Austria
State/province [17] 0 0
Wein
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Sofia
Country [19] 0 0
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
State/province [21] 0 0
Lille Cedex
Country [22] 0 0
France
State/province [22] 0 0
Lille
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Frankfurt
Country [26] 0 0
Germany
State/province [26] 0 0
Mainz
Country [27] 0 0
Germany
State/province [27] 0 0
Morfelden-Walldorf
Country [28] 0 0
Greece
State/province [28] 0 0
Athens
Country [29] 0 0
Hungary
State/province [29] 0 0
Budapest
Country [30] 0 0
Israel
State/province [30] 0 0
Haifa
Country [31] 0 0
Israel
State/province [31] 0 0
Petach Tikvah
Country [32] 0 0
Israel
State/province [32] 0 0
Ramat Gan
Country [33] 0 0
Israel
State/province [33] 0 0
Tel Aviv
Country [34] 0 0
Italy
State/province [34] 0 0
Padova
Country [35] 0 0
Italy
State/province [35] 0 0
Palermo
Country [36] 0 0
Italy
State/province [36] 0 0
Roma
Country [37] 0 0
Italy
State/province [37] 0 0
San Donato Milanese
Country [38] 0 0
Japan
State/province [38] 0 0
Hokkaido
Country [39] 0 0
Japan
State/province [39] 0 0
Chiba-shi
Country [40] 0 0
Japan
State/province [40] 0 0
Hiroshima-shi
Country [41] 0 0
Japan
State/province [41] 0 0
Kawagoe-shi
Country [42] 0 0
Japan
State/province [42] 0 0
Maebashi-city
Country [43] 0 0
Japan
State/province [43] 0 0
Soka-shi
Country [44] 0 0
Japan
State/province [44] 0 0
Takatsuki-shi
Country [45] 0 0
Japan
State/province [45] 0 0
Tokyo
Country [46] 0 0
Japan
State/province [46] 0 0
Yokohama-shi
Country [47] 0 0
Netherlands
State/province [47] 0 0
Amsterdam
Country [48] 0 0
New Zealand
State/province [48] 0 0
Auckland
Country [49] 0 0
North Macedonia
State/province [49] 0 0
Skopje
Country [50] 0 0
Poland
State/province [50] 0 0
Kraków
Country [51] 0 0
Poland
State/province [51] 0 0
Lódz
Country [52] 0 0
Portugal
State/province [52] 0 0
Porto
Country [53] 0 0
Romania
State/province [53] 0 0
Sângeorgiu De Mures
Country [54] 0 0
Saudi Arabia
State/province [54] 0 0
Riyadh
Country [55] 0 0
Slovakia
State/province [55] 0 0
Martin
Country [56] 0 0
South Africa
State/province [56] 0 0
Cape Town
Country [57] 0 0
Spain
State/province [57] 0 0
Barcelona
Country [58] 0 0
Spain
State/province [58] 0 0
Madrid
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Birmingham
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Cambridge
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Cardiff
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Frimley
Country [63] 0 0
United Kingdom
State/province [63] 0 0
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05505916
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
clinicalstudies@kalvista.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05505916