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Small Molecule

KVD824 for Hereditary Angioedema (KVD824-201 Trial)

Phase 2

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

Male or female subjects 18 years of age and older.

Documented clinical history consistent with HAE (subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria) AND EITHER

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

KVD824-201 Trial Summary

This trial will test the effectiveness of different doses of KVD824 in preventing attacks of Hereditary Angiodedema (HAE).

Eligible Conditions

Hereditary Angioedema

KVD824-201 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

KVD824-201 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

The Rate of Investigator-confirmed HAE attacks during the Treatment Period

Secondary outcome measures

Angioedema Control Test (AECT) score and domain scores during the Treatment Period.

Angioedema Quality of Life Questionnaire (AE-QoL) total score and domain scores during the Treatment Period.

Proportion of subjects with an AECT score ≥12 at the end of the Treatment Period.

+2 more

KVD824-201 Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 900 mg KVD824Experimental Treatment1 Intervention

Three 300 mg KVD824 tablets twice a day for 12 weeks

Group II: 600 mg KVD824Experimental Treatment1 Intervention

Two 300 mg KVD824 tablets twice a day for 12 weeks

Group III: 300 mg KVD824Experimental Treatment1 Intervention

300 mg KVD824 twice a day for 12 weeks

Group IV: Placebo to KVD824Placebo Group1 Intervention

One, two or three placebo tablets to be taken twice a day for 12 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

KVD824

2019

Completed Phase 1

~110

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

KalVista Pharmaceuticals, Ltd.Lead Sponsor

9 Previous Clinical Trials

754 Total Patients Enrolled

Study DirectorStudy DirectorKalVista Pharmaceuticals

1,205 Previous Clinical Trials

489,748 Total Patients Enrolled

Frequently Asked Questions

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

Are patients presently being sought for this clinical trial?

"That is accurate. The information available on clinicaltrials.gov reveals that this study is presently looking for participants. This trial was originally posted on September 27th, 2021 and was last updated on September 16th, 2022. A total of 48 individuals are needed across 16 sites."

Answered by AI

Has the FDA cleared KVD824 for public consumption?

"KVD824's safety was rated a 2 by our team because, while there is some evidence of the drug's safety, there is no data yet supporting its efficacy."

Answered by AI

How many people are receiving help through this clinical trial?

"That is correct, the online information for this clinical trial indicates that it is still recruiting patients. The first posting was on September 27th, 2021 and the latest update was on September 16th, 2022. A total of 48 patients will be enrolled at 16 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial to Evaluate the Efficacy and Safety of Different Doses of KVD824 for Prophylactic Treatment of HAE Type I or II

2021. "A Trial to Evaluate the Efficacy and Safety of Different Doses of KVD824 for Prophylactic Treatment of HAE Type I or II". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05055258.