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Unknown

KVD900 for Hereditary Angioedema

Phase 3

Recruiting

Research Sponsored by KalVista Pharmaceuticals, Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 hours after imp administration

Awards & highlights

Study Summary

This trial is looking at how a new drug affects teenagers with Hereditary Angioedema.

Who is the study for?

Adolescents aged 12-17 with Hereditary Angioedema (HAE) types I or II can join this trial if they're already in the KVD900-302 study. They must be willing to provide samples, complete forms and diaries, and have consent from a legal representative.Check my eligibility

What is being tested?

The trial is testing how the body processes KVD900, a drug for HAE. It's specifically looking at its pharmacokinetics—how the drug is absorbed, distributed, metabolized, and excreted—in adolescents.See study design

What are the potential side effects?

While specific side effects of KVD900 are not listed here, common ones may include reactions at the injection site, nausea or headaches. More serious risks could involve allergic reactions or issues related to bleeding disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 hours after imp administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 hours after imp administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 hours after imp administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pharmacokinetics - AUC

Pharmacokinetics - Cmax

Pharmacokinetics - Tmax

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

KalVista Pharmaceuticals, Ltd.Lead Sponsor

9 Previous Clinical Trials

775 Total Patients Enrolled

Study DirectorStudy DirectorKalVista Pharmaceuticals, Ltd.

1,209 Previous Clinical Trials

489,452 Total Patients Enrolled

Media Library

KVD900 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05511922 — Phase 3

Hereditary Angioedema Research Study Groups: KVD900 600 mg

Hereditary Angioedema Clinical Trial 2023: KVD900 Highlights & Side Effects. Trial Name: NCT05511922 — Phase 3

KVD900 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05511922 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the standards for participants in this trial?

"This clinical trial is enrolling 12 patients with a history of angioedema, specifically those aged 12 to 17. The key requirements for participants are as follows: they must be male or female, willing and able to provide the required samples within the specified age limit, have signed informed consent forms (or assent forms if applicable), and have a legally authorized representative who has also given signed informed consent when applicable."

Answered by AI

Are we still enrolling people for this experiment?

"The clinical trial is actively recruiting patients, with 12 needed at 6 sites. The first posting was on 10/24/2022, and the most recent update was on 10/31/2022 according to data available on clinicaltrials.gov."

Answered by AI

Does this trial have an age limit? If so, what is it?

"Children aged 12 to 17 who meet the other specified criteria can participate in this clinical trial. In total, there are 31 trials for patients under 18 and 19 for people over 65."

Answered by AI

Has KVD900 600 mg received FDA approval for use?

"KVD900 600 mg falls into Phase 3 of clinical trials, so there is some evidence of efficacy as well as multiple rounds of data supporting safety. Therefore, it receives a score of 3 for safety."

Answered by AI

Are several hospitals in the city conducting this research?

"Currently, there are 6 sites enrolling patients for this study with locations in Saint Louis, Colorado Springs and Scottsdale. To lessen the burden of travel, please select the nearest location to you if you decide to participate."

Answered by AI

How many total participants are needed for this research project?

"Yes, this is an ongoing study that has opened recruitment at 6 sites across the United States of America. So far, 12 patients have been successfully recruited out of the desired 100."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial

2022. "PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05511922.

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