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Bradykinin B2 receptor antagonist
Long-Term Safety of 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
Confirmed diagnosis of HAE type I or II at any time in the medical history
Patients must be able to swallow trial tablets whole
Timeline
Screening 3 weeks
Treatment Varies
Follow Up aes will be recorded from the first dose of imp in the kvd900-302 trial up to and including the end of study (eos) visit, a maximum of 2 years for each patient.
Awards & highlights
Study Summary
This trial is to study the long-term safety of a drug called KVD900 in people with a hereditary disease called HAE.
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.Check my eligibility
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.See study design
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 belowSelect...
I have been diagnosed with hereditary angioedema type I or II.
Select...
I can swallow pills without any difficulty.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ aes will be recorded from the first dose of imp in the kvd900-302 trial up to and including the end of study (eos) visit, a maximum of 2 years for each patient.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~aes will be recorded from the first dose of imp in the kvd900-302 trial up to and including the end of study (eos) visit, a maximum of 2 years for each patient.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequencies and percentages of patients with AEs, AEs within 2 days of IMP administration, serious AE's and AEs causing premature discontinuation.
Number and percentage of patients with normal or abnormal laboratory results at each scheduled visit.
Number and percentage of patients with normal or abnormal vital sign results at each scheduled visit
Secondary outcome measures
PGI-S: time to HAE attack resolution
Patient Global Impression of Change (PGI-C).
Patient Global Impression of Severity (PGI-S): time to first incidence of 2 time points in a row decrease from baseline
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
Find a Location
Who is running the clinical trial?
KalVista Pharmaceuticals, Ltd.Lead Sponsor
9 Previous Clinical Trials
637 Total Patients Enrolled
Study DirectorStudy DirectorKalVista Pharmaceuticals, Ltd.
1,209 Previous Clinical Trials
489,560 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not responded well to certain HAE treatments, as judged by my doctor.I have been diagnosed with hereditary angioedema type I or II.I am willing and able to follow all study requirements.My liver function is not within the normal range, or I have other significant health issues.I can swallow pills without any difficulty.I haven't taken specific hormone treatments or certain blood clot prevention drugs in the last 28 days.I haven't taken ACE inhibitors in the last 7 days.I haven't taken any estrogen-based medications in the last 7 days.I have been on a stable dose of my current medication for at least 3 months, or 6 months if it's danazol.I have not participated in any gene therapy trials for HAE.I am 12 years old or older.You have experienced at least 2 attacks of hereditary angioedema (HAE) in the 3 months before the study starts.You are allergic to KVD900 or any of its ingredients.I have been diagnosed with a chronic form of angioedema other than hereditary.
Research Study Groups:
This trial has the following groups:- Group 1: KVD900 600 mg
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has KVD900 600 mg been cleared by the FDA?
"KVD900 600 mg scored a 3 for safety. This is due to the fact that it is a Phase 3 trial, which includes data showing some efficacy as well as multiple rounds of evidence affirming its safety."
Answered by AI
Could you tell us how many test locations are participating in this experiment?
"Presently, this clinical trial is looking for participants from 6 locations. These include cities such as Louisville, Saint Louis and Colorado Springs. If you are considering participation, please choose the site that is most proximal to your location in order to reduce travel time commitments."
Answered by AI
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