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Bradykinin B2 receptor antagonist

Long-Term Safety of KVD900 for Hereditary Angioedema

Phase 3
Waitlist Available
Research Sponsored by KalVista Pharmaceuticals, Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of HAE type I or II at any time in the medical history
Patients must be able to swallow trial tablets whole
Must not have
Inadequate organ function, including but not limited to: Alanine aminotransferase (ALT) >2x Upper Limit Normal (ULN), Aspartate aminotransferase (AST) >2x ULN, Bilirubin direct >1.25x ULN, International Normalized Ratio (INR) >1.2, Clinically significant hepatic impairment defined as a Child-Pugh B or C, 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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 12 hours of initial dose of imp administration.
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include allergic reactions to KVD900 or its ingredients. Patients with previous poor responses to related treatments might also anticipate similar issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with hereditary angioedema type I or II.
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I can swallow pills without any difficulty.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver function is not within the normal range, or I have other significant health issues.
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I haven't taken any estrogen-based medications in the last 7 days.
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I have not participated in any gene therapy trials for HAE.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 12 hours of initial dose of imp administration.
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 12 hours of initial dose of imp administration. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
PGI-S: time to HAE attack resolution
Patient Global Impression of Change (PGI-C).

Side effects data

From 2023 Phase 3 trial • 136 Patients • NCT05259917
3%
HEADACHE
1%
HEREDITARY ANGIOEDEMA
1%
ANISOCORIA
1%
VOMITING
1%
NAUSEA
1%
DIZZINESS
100%
80%
60%
40%
20%
0%
Study treatment Arm
KVD900 600 mg
Placebo
KVD900 300 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: KVD900 600 mgExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KVD900 600 mg
2022
Completed Phase 3
~140

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Hereditary Angioedema (HAE) is commonly treated with medications that target the bradykinin pathway, as bradykinin is a key mediator of the swelling attacks characteristic of HAE. Treatments include C1 esterase inhibitors, which replace the deficient or dysfunctional C1 inhibitor protein, and Kallikrein inhibitors like KVD900, which prevent the activation of kallikrein and subsequent production of bradykinin. Additionally, bradykinin receptor antagonists block the effects of bradykinin on its receptors. These treatments are crucial for HAE patients as they directly address the underlying pathophysiology of the disease, thereby reducing the frequency and severity of angioedema attacks and improving patients' quality of life.
Ecallantide for treatment of acute attacks of acquired C1 esterase inhibitor deficiency.

Find a Location

Who is running the clinical trial?

KalVista Pharmaceuticals, Ltd.Lead Sponsor
10 Previous Clinical Trials
661 Total Patients Enrolled
Study DirectorStudy DirectorKalVista Pharmaceuticals, Ltd.
1,260 Previous Clinical Trials
503,217 Total Patients Enrolled

Media Library

KVD900 (Bradykinin B2 receptor antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05505916 — Phase 3
Hereditary Angioedema Research Study Groups: KVD900 600 mg
Hereditary Angioedema Clinical Trial 2023: KVD900 Highlights & Side Effects. Trial Name: NCT05505916 — Phase 3
KVD900 (Bradykinin B2 receptor antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05505916 — Phase 3
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