Long-Term Safety of KVD900 for Hereditary Angioedema

Recruiting in Palo Alto (17 mi)

+67 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: KalVista Pharmaceuticals, Ltd.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial tests the long-term safety of KVD900 in individuals with HAE. KVD900 aims to reduce symptoms by blocking proteins that cause swelling. Another treatment, Berotralstat, is used to prevent HAE attacks.

Eligibility Criteria

This trial is for adolescents and adults aged 12 or older with Hereditary Angioedema (HAE) types I or II. Participants must have had at least two HAE attacks in the past three months, be on a stable dose of certain prophylactic treatments if applicable, and able to swallow tablets whole. They should not have any known hypersensitivity to KVD900, poor response to similar therapies, significant organ dysfunction, or be pregnant/breastfeeding.

Inclusion Criteria

Patient provides signed informed consent or assent (when applicable). A parent or legally authorized representative (LAR) must also provide signed informed consent when required

I have been diagnosed with hereditary angioedema type I or II.

I am willing and able to follow all study requirements.

+6 more

Exclusion Criteria

I have not responded well to certain HAE treatments, as judged by my doctor.

History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator

My liver function is not within the normal range, or I have other significant health issues.

+10 more

Participant Groups

The trial is testing the long-term safety of an oral medication called KVD900 at a dose of 600 mg. It's designed for patients who experience angioedema attacks due to HAE. As an open-label extension study, all participants will receive the drug without any placebo comparison.

2Treatment groups

Experimental Treatment

Group I: KVD900 600 mgExperimental Treatment1 Intervention

Group II: KVD900 300 mgExperimental Treatment1 Intervention

KVD900 is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as sebetralstat for: