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Plasma Kallikrein Inhibitor
Sebetralstat for Hereditary Angioedema (KONFIDENT-KID Trial)
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
Male or female patients 2 to 11 years of age
Confirmed diagnosis of HAE Type I or II
Must not have
Any concomitant diagnosis of another form of chronic angioedema
Patient weighs <9.5 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is open to children aged 2 to 11 years old with a certain type of hereditary angioedema.
Who is the study for?
This trial is for children aged 2-11 with Hereditary Angioedema (HAE) Types I or II who've had at least one HAE attack in the past year. A parent or guardian must consent, and caregivers need to be able to manage treatment and follow the study's diary requirements.
What is being tested?
The trial tests three doses of Sebetralstat (KVD900): 75 mg, 150 mg, and 300 mg. It's an open-label study where everyone knows what treatment they're getting, aiming to assess safety, how the body processes the drug, and its effectiveness against HAE.
What are the potential side effects?
While specific side effects are not listed here, common ones for similar medications may include reactions at injection sites, nausea, headache, rash or fatigue. Each child's experience can vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 2 and 11 years old.
Select...
I have been diagnosed with HAE Type I or II.
Select...
I have had at least one hereditary angioedema attack in the past year.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with another type of chronic swelling.
Select...
I weigh less than 9.5 kg.
Select...
I started taking ACE inhibitors after my screening visit.
Select...
I have not taken any estrogen medications in the last 7 days.
Select...
I am not on strong or moderate drugs that affect liver enzyme CYP3A4.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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
3Treatment groups
Experimental Treatment
Group I: 75 mg Dose GroupExperimental Treatment1 Intervention
Patients will take a single 75 mg dose of KVD900.
Group II: 300 mg Dose GroupExperimental Treatment1 Intervention
Patients will take a single 300 mg dose of KVD900.
Group III: 150 mg Dose GroupExperimental Treatment1 Intervention
Patients will take a single 150 mg dose of KVD900 dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KVD900 300 mg
2022
Completed Phase 3
~140
Find a Location
Who is running the clinical trial?
KalVista Pharmaceuticals, Ltd.Lead Sponsor
11 Previous Clinical Trials
782 Total Patients Enrolled
Study DirectorStudy DirectorKalVista Pharmaceuticals, Ltd.
1,288 Previous Clinical Trials
501,728 Total Patients Enrolled