What side effects are associated with this type of intervention?

Common treatments for Hereditary Angioedema (HAE) include kallikrein inhibitors like KVD900, C1 esterase inhibitors, and bradykinin receptor antagonists. Known side effects of kallikrein inhibitors can include headache, nausea, dizziness, and injection site reactions. C1 esterase inhibitors may cause hypersensitivity reactions, thromboembolic events, and injection site pain. Bradykinin receptor antagonists can lead to nausea, dizziness, and injection site reactions. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for Hereditary Angioedema (HAE), including C1 esterase inhibitors (e.g., Berinert, Cinryze), bradykinin receptor antagonists (e.g., Icatibant), and kallikrein inhibitors (e.g., Ecallantide). These treatments aim to prevent or manage acute HAE attacks by targeting different pathways involved in the disease. KVD900, currently under study, is a novel oral kallikrein inhibitor, similar to Ecallantide, which inhibits plasma kallikrein to reduce bradykinin production and alleviate symptoms.

What other types of research exist?

Promising novel alternatives to KVD900 for Hereditary Angioedema patients include lanadelumab, a monoclonal antibody that inhibits plasma kallikrein, and berotralstat, an oral plasma kallikrein inhibitor. Both have shown efficacy in reducing HAE attack frequency and are considered potential treatments for 2024.

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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

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 12 hours of initial dose of imp administration.

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

HEADACHE

ANISOCORIA

NAUSEA

VOMITING

HEREDITARY ANGIOEDEMA

DIZZINESS

100%

80%

60%

40%

20%

Study treatment Arm

KVD900 600 mg

Placebo

KVD900 300 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 5Eligibility criteria met

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.