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)

March 6, 2024 updated by: KalVista Pharmaceuticals, Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Campbelltown, Australia, 2560
        • Recruiting
        • KalVista Investigative Site
  • Austria
      • Wein, Austria, 1090
        • Recruiting
        • KalVista Investigative Site
  • Bulgaria
      • Sofia, Bulgaria, 1431
        • Recruiting
        • KalVista Investigative Site
  • Canada
      • Montréal, Canada, H2W 1R7
        • Recruiting
        • KalVista Investigative Site
  • France
      • Grenoble Cedex 9, France, 38043
        • Recruiting
        • KalVista Investigative Site
      • Lille, France, 59037
        • Recruiting
        • KalVista Investigative Site
      • Lille Cedex, France, 59037
        • Recruiting
        • KalVista Investigative Site
      • Paris, France, 75012
        • Recruiting
        • KalVista Investigative Site
  • Germany
      • Berlin, Germany, 12203
        • Recruiting
        • KalVista Investigative Site
      • Frankfurt, Germany, 60590
        • Recruiting
        • KalVista Investigative Site
      • Mainz, Germany, 55131
        • Recruiting
        • KalVista Investigative Site
      • Morfelden-Walldorf, Germany, 64546
        • Recruiting
        • KalVista Investigative Site
  • Greece
      • Athens, Greece, 11521
        • Recruiting
        • KalVista Investigative Site
      • Athens, Greece, 11527
        • Recruiting
        • KalVista Investigative Site
  • Hungary
      • Budapest, Hungary, 1088
        • Recruiting
        • KalVista Investigative Site
  • Israel
      • Haifa, Israel, 31048
        • Recruiting
        • KalVista Investigative Site
      • Petach Tikvah, Israel, 4920235
        • Recruiting
        • KalVista Investigative Site
      • Ramat Gan, Israel, 52621
        • Recruiting
        • KalVista Investigative Site
      • Tel Aviv, Israel, 64239
        • Recruiting
        • KalVista Investigative Site
  • Italy
      • Padova, Italy, 35128
        • Recruiting
        • KalVista Investigative Site
      • Palermo, Italy, 90146
        • Recruiting
        • KalVista Investigative Site
      • Roma, Italy, 00133
        • Recruiting
        • KalVista Investigative Site
      • San Donato Milanese, Italy, 20097
        • Recruiting
        • KalVista Investigative Site
  • Japan
      • Chiba-shi, Japan, 260-8677
        • Active, not recruiting
        • KalVista Investigative Site
      • Hiroshima-shi, Japan, 730-8518
        • Active, not recruiting
        • KalVista Investigative Site
      • Kawagoe-shi, Japan, 350-8550
        • Active, not recruiting
        • KalVista Investigative Site
      • Maebashi-city, Japan, 371-8511
        • Active, not recruiting
        • KalVista Investigative Site
      • Soka-shi, Japan, 340-0041
        • Active, not recruiting
        • KalVista Investigative Site
      • Takatsuki-shi, Japan, 569-8686
        • Active, not recruiting
        • KalVista Investigative Site
      • Tokyo, Japan, 142-8666
        • Active, not recruiting
        • KalVista Investgative Site
      • Yokohama-shi, Japan, 236-0004
        • Active, not recruiting
        • KalVista Investigative Site
    • Hokkaido
      • Sapporo-city, Hokkaido, Japan, 002-8072
        • Active, not recruiting
        • KalVista Investigative Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Recruiting
        • KalVista Investigative Site
  • New Zealand
      • Auckland, New Zealand, 1023
        • Recruiting
        • KalVista Investigative Site
  • North Macedonia
      • Skopje, North Macedonia, 1000
        • Recruiting
        • KalVista Investigative Site
  • Poland
      • Kraków, Poland, 31-503
        • Recruiting
        • KalVista Investigative Site
      • Łódź, Poland, 92-213
        • Recruiting
        • KalVista Investigative Site
  • Portugal
      • Porto, Portugal, 4200-319
        • Recruiting
        • KalVista Investigative Site
  • Romania
      • Sângeorgiu De Mureş, Romania, 547530
        • Recruiting
        • KalVista Investigative Site
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11211
        • Recruiting
        • KalVista Investigative Site
  • Slovakia
      • Martin, Slovakia, 036 59
        • Recruiting
        • KalVista Investigative Site
  • South Africa
      • Cape Town, South Africa, 7700
        • Recruiting
        • KalVista Investigative Site
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • KalVista Investigative Site
      • Barcelona, Spain, 08907
        • Recruiting
        • KalVista Investigative Site
      • Madrid, Spain, 28046
        • Recruiting
        • KalVista Investigative Site
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Recruiting
        • KalVista Investigative Site
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • KalVista Investigative Site
      • Cardiff, United Kingdom, CF14 4XW
        • Recruiting
        • KalVista Investigative Site
      • Frimley, United Kingdom, GU16 7UJ
        • Recruiting
        • KalVista Investigative Site
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • KalVista Investigative Site
      • London, United Kingdom, E1 2ES
        • Recruiting
        • KalVista Investigative Site
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • KalVista Investigative Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Recruiting
        • KalVista Investigative Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • KalVista Investigative Site
    • California
      • San Diego, California, United States, 92122
        • Recruiting
        • KalVista Investigative Site
      • San Diego, California, United States, 92123
        • Recruiting
        • KalVista Investigative Site
      • Santa Monica, California, United States, 90404
        • Recruiting
        • KalVista Investigative Site
    • Colorado
      • Centennial, Colorado, United States, 80112
        • Active, not recruiting
        • KalVista Investigative Site
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • KalVista Investigative Site
    • Indiana
      • Evansville, Indiana, United States, 47715
        • Recruiting
        • KalVista Investigative Site
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • KalVista Investigative Site
    • Kentucky
      • Louisville, Kentucky, United States, 40215
        • Completed
        • KalVista Investigative Site
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Recruiting
        • KalVista Investigative Site
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Recruiting
        • KalVista Investigative Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • KalVista Investigative Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Active, not recruiting
        • KalVista Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Recruiting
        • KalVista Investigative Site
      • Toledo, Ohio, United States, 43617
        • Recruiting
        • KalVista Investigative Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • KalVista Investigative Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • KalVista Investigative Site
    • Utah
      • Layton, Utah, United States, 84041
        • Recruiting
        • KalVista Investgative Site
    • Washington
      • Spokane, Washington, United States, 99204
        • Recruiting
        • KalVista Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Patients may roll over from KVD900-301.

Inclusion Criteria:

  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.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KVD900 600 mg
Drug: KVD900 600 mg
KVD900 Tablet 600 mg (2 x 300 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequencies and percentages of patients with AEs, AEs within 2 days of IMP administration, serious AE's and AEs causing premature discontinuation.
Time Frame: 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.
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.
Number and percentage of patients with normal or abnormal laboratory results at each scheduled visit.
Time Frame: Throughout the duration of the trial.
Throughout the duration of the trial.
Number and percentage of patients with normal or abnormal vital sign results at each scheduled visit
Time Frame: Throughout the duration of the trial.
Throughout the duration of the trial.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Global Impression of Change (PGI-C).
Time Frame: within 12 hours of initial dose of IMP administration.
time to beginning of symptom relief defined as at least '' a little better'' (2 time points in a row)
within 12 hours of initial dose of IMP administration.
Patient Global Impression of Severity (PGI-S): time to first incidence of 2 time points in a row decrease from baseline
Time Frame: within 12 hours of initial dose of IMP administration.
within 12 hours of initial dose of IMP administration.
PGI-S: time to HAE attack resolution
Time Frame: within 24 hours of initial dose of IMP administration.
PGI-S: time to HAE attack resolution, defines as ''none''
within 24 hours of initial dose of IMP administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KalVista Pharmaceuticals, Ltd.

Investigators

  • Study Director: Study Director, KalVista Pharmaceuticals, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2022

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

January 30, 2026

Study Registration Dates

First Submitted

August 11, 2022

First Submitted That Met QC Criteria

August 17, 2022

First Posted (Actual)

August 18, 2022

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KVD900-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be shared until all global regulatory filings are complete.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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