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New pill shows promise for controlling rare swelling disorder

NCT ID NCT05505916

Disease control Sponsor: KalVista Pharmaceuticals, Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at the long-term safety of an oral medication called KVD900 for treating swelling attacks in people with hereditary angioedema (HAE) types I or II. The trial enrolled 145 adolescents and adults who had already completed a previous study. Participants took KVD900 tablets as needed during an attack. The main goal was to track side effects and lab results over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KVD900 (an oral plasma kallikrein inhibitor)
What this could lead to
If successful, this could provide a convenient, on-demand oral treatment option for hereditary angioedema attacks, reducing the need for injections.
What could go wrong
This is an extension trial focused on safety, not proof of effectiveness. The drug may still have side effects or not work for everyone. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

145 people

The number who actually took part.

Started

Oct 2022

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hereditary angioedema hereditary angioedema type 1 hereditary angioedema type 2

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hereditary angioedema

Contacts and locations

Locations

  • KalVista Investgative Site

    Layton, Utah, 84041, United States

  • KalVista Investgative Site

    Tokyo, 142-8666, Japan

  • KalVista Investigative Site

    Scottsdale, Arizona, 85251, United States

  • KalVista Investigative Site

    Little Rock, Arkansas, 72205, United States

  • KalVista Investigative Site

    San Diego, California, 92122, United States

  • KalVista Investigative Site

    San Diego, California, 92123, United States

  • KalVista Investigative Site

    Santa Monica, California, 90404, United States

  • KalVista Investigative Site

    Centennial, Colorado, 80112, United States

  • KalVista Investigative Site

    Colorado Springs, Colorado, 80907, United States

  • KalVista Investigative Site

    Evansville, Indiana, 47715, United States

  • KalVista Investigative Site

    Overland Park, Kansas, 66211, United States

  • KalVista Investigative Site

    Louisville, Kentucky, 40215, United States

  • KalVista Investigative Site

    Chevy Chase, Maryland, 20815, United States

  • KalVista Investigative Site

    Plymouth, Minnesota, 55446, United States

  • KalVista Investigative Site

    St Louis, Missouri, 63141, United States

  • KalVista Investigative Site

    Charlotte, North Carolina, 28277, United States

  • KalVista Investigative Site

    Cincinnati, Ohio, 45236, United States

  • KalVista Investigative Site

    Toledo, Ohio, 43617, United States

  • KalVista Investigative Site

    Hershey, Pennsylvania, 17033, United States

  • KalVista Investigative Site

    Dallas, Texas, 75231, United States

  • KalVista Investigative Site

    Spokane, Washington, 99204, United States

  • KalVista Investigative Site

    Campbelltown, 2560, Australia

  • KalVista Investigative Site

    Wein, 1090, Austria

  • KalVista Investigative Site

    Sofia, 1431, Bulgaria

  • KalVista Investigative Site

    Montreal, H2W 1R7, Canada

  • KalVista Investigative Site

    Grenoble, 38043, France

  • KalVista Investigative Site

    Lille, 59037, France

  • KalVista Investigative Site

    Paris, 75012, France

  • KalVista Investigative Site

    Berlin, 12203, Germany

  • KalVista Investigative Site

    Frankfurt, 60590, Germany

  • KalVista Investigative Site

    Mainz, 55131, Germany

  • KalVista Investigative Site

    Mörfelden-Walldorf, 64546, Germany

  • KalVista Investigative Site

    Athens, 11521, Greece

  • KalVista Investigative Site

    Athens, 11527, Greece

  • KalVista Investigative Site

    Budapest, 1088, Hungary

  • KalVista Investigative Site

    Haifa, 31048, Israel

  • KalVista Investigative Site

    Petach Tikvah, 4920235, Israel

  • KalVista Investigative Site

    Ramat Gan, 52621, Israel

  • KalVista Investigative Site

    Tel Aviv, 64239, Israel

  • KalVista Investigative Site

    Padova, 35128, Italy

  • KalVista Investigative Site

    Palermo, 90146, Italy

  • KalVista Investigative Site

    Roma, 00133, Italy

  • KalVista Investigative Site

    San Donato Milanese, 20097, Italy

  • KalVista Investigative Site

    Sapporo, Hokkaido, 002-8072, Japan

  • KalVista Investigative Site

    Chiba, 260-8677, Japan

  • KalVista Investigative Site

    Hiroshima, 730-8518, Japan

  • KalVista Investigative Site

    Kawagoe-shi, 350-8550, Japan

  • KalVista Investigative Site

    Maebashi, 371-8511, Japan

  • KalVista Investigative Site

    Soka-shi, 340-0041, Japan

  • KalVista Investigative Site

    Takatsuki-shi, 569-8686, Japan

  • KalVista Investigative Site

    Yokohama, 236-0004, Japan

  • KalVista Investigative Site

    Amsterdam, 1105 AZ, Netherlands

  • KalVista Investigative Site

    Auckland, 1023, New Zealand

  • KalVista Investigative Site

    Skopje, 1000, North Macedonia

  • KalVista Investigative Site

    Krakow, 31-503, Poland

  • KalVista Investigative Site

    Lodz, 92-213, Poland

  • KalVista Investigative Site

    Porto, 4200-319, Portugal

  • KalVista Investigative Site

    Sângeorgiu de Mureş, 547530, Romania

  • KalVista Investigative Site

    Riyadh, 11211, Saudi Arabia

  • KalVista Investigative Site

    Martin, 036 59, Slovakia

  • KalVista Investigative Site

    Barcelona, 08035, Spain

  • KalVista Investigative Site

    Barcelona, 08907, Spain

  • KalVista Investigative Site

    Madrid, 28046, Spain

  • KalVista Investigative Site

    Birmingham, B9 5SS, United Kingdom

  • KalVista Investigative Site

    Cambridge, CB2 0QQ, United Kingdom

  • KalVista Investigative Site

    Cardiff, CF14 4XW, United Kingdom

  • KalVista Investigative Site

    Frimley, GU16 7UJ, United Kingdom

  • KalVista Investigative Site

    Leeds, LS9 7TF, United Kingdom

  • KalVista Investigative Site

    London, E1 2ES, United Kingdom

  • KalVista Investigative Site

    London, NW3 2QG, United Kingdom

  • Kalvista Investigative Site

    Cape Town, 7700, South Africa

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Other studies related to the condition(s) this trial covers.