Trial · NCT05259917
A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
NCT05259917, Phase 3, Completed, KalVista Pharmaceuticals, Ltd.; results first posted 2024-07-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE). Trials, record NCT05259917. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05259917
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
- NCT number
- NCT05259917
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 136 participants, actual
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.
- Conditions
- Hereditary Angioedema
- Interventions
- Placebo, KVD900 600 mg, KVD900 300 mg
- First posted
- 2022-03-02
- Last updated
- 2025-05-02
- Results first posted
- 2024-07-19
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Beginning of Symptom Relief Patient Global Impression of Change (PGI-C) | Within 12 hours of the first investigational medicinal product (IMP) administration. | The analysis of time to the beginning of symptom relief defined as at least "a little better" (2 time points in a row) on the PGI-C within 12 hours of the first IMP administration using the Gehan score transformation test for Full Analysis Set (FAS). Attacks were treated as right-censored at 12 hours if they did not achieve beginning of symptom relief defined by PGI-C as at least "a little better" (2 time points in a row) or received conventional attack treatment prior to time-to-event within 12 hours of the first IMP administration. When an endpoint result was non-evaluable (NE) within 12 hours, if the event did occur, the event must have occurred \>12 hours following study drug. |
| Secondary | Time to First Incidence of Decrease From Baseline Patient Global Impression of Severity (PGI-S) (2 Time Points in a Row) | Within 12 hours of the first IMP administration. | First incidence of decrease in attack severity at two time points in a row (with possible missing values in between) within 12 hours of the first IMP administration. Attacks were treated as right-censored at 12 hours if they did not have a decrease in PGI-S score from baseline for 2 time points in a row or received conventional attack treatment prior to time-to-event within 12 hours of the first IMP administration. When an endpoint result was non-evaluable (NE) within 12 hours, if the event did occur, the event must have occurred \>12 hours following study drug. |
| Secondary | Time to Complete HAE Attack Resolution (PGI-S) | Within 24 hours of the first IMP administration. | Time to complete HAE attack resolution defined as "none". Attacks were treated as right-censored at 24 hours if they did reach complete HAE attack resolution or received conventional attack treatment prior to time-to-event within 24 hours of IMP administration. When an endpoint result was non-evaluable (NE) within 24 hours, if the event did occur, the event must have occurred \>24 hours following study drug. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Beginning of Symptom Relief Patient Global Impression of Change (PGI-C) | Within 12 hours of the first investigational medicinal product (IMP) administration. | The full analysis set (FAS) included all randomized patients who received trial medication from at least one period for the respective qualifying HAE attack and are presented according to the randomized treatment. The FAS was the population for efficacy analyses. | Time (h) | MEDIAN |
| SECONDARY | Time to First Incidence of Decrease From Baseline Patient Global Impression of Severity (PGI-S) (2 Time Points in a Row) | Within 12 hours of the first IMP administration. | The full analysis set (FAS) included all randomized patients who received trial medication from at least one period for the respective qualifying HAE attack and are presented according to the randomized treatment. The FAS was the population for efficacy analyses. | Time (h) | MEDIAN |
| SECONDARY | Time to Complete HAE Attack Resolution (PGI-S) | Within 24 hours of the first IMP administration. | The full analysis set (FAS) included all randomized patients who received trial medication from at least one period for the respective qualifying HAE attack and are presented according to the randomized treatment. The FAS was the population for efficacy analyses. | Time (h) | MEDIAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Beginning of Symptom Relief Patient Global Impression of Change (PGI-C) | KVD900 300 mg | 1.61 | 95% Confidence Interval 1.28 to 2.27 | Time (h) | |
| Time to Beginning of Symptom Relief Patient Global Impression of Change (PGI-C) | KVD900 600 mg | 1.79 | 95% Confidence Interval 1.33 to 2.27 | Time (h) | |
| Time to Beginning of Symptom Relief Patient Global Impression of Change (PGI-C) | Placebo | 6.72 | 95% Confidence Interval 2.33 to NA | Time (h) | |
| Time to First Incidence of Decrease From Baseline Patient Global Impression of Severity (PGI-S) (2 Time Points in a Row) | KVD900 300 mg | 9.27 | 95% Confidence Interval 4.08 to NA | Time (h) | |
| Time to First Incidence of Decrease From Baseline Patient Global Impression of Severity (PGI-S) (2 Time Points in a Row) | KVD900 600 mg | 7.75 | 95% Confidence Interval 3.27 to NA | Time (h) | |
| Time to First Incidence of Decrease From Baseline Patient Global Impression of Severity (PGI-S) (2 Time Points in a Row) | Placebo | NA | 95% Confidence Interval NA to NA | Time (h) | |
| Time to Complete HAE Attack Resolution (PGI-S) | KVD900 300 mg | NA | 95% Confidence Interval 16.60 to NA | Time (h) | |
| Time to Complete HAE Attack Resolution (PGI-S) | KVD900 600 mg | 24.00 | 95% Confidence Interval 10.60 to NA | Time (h) | |
| Time to Complete HAE Attack Resolution (PGI-S) | Placebo | NA | 95% Confidence Interval NA to NA | Time (h) |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sequence A | 18 | |
| Overall Study | STARTED | Sequence B | 18 | |
| Overall Study | STARTED | Sequence C | 15 | |
| Overall Study | STARTED | Sequence D | 17 | |
| Overall Study | STARTED | Sequence E | 20 | |
| Overall Study | STARTED | Sequence F | 22 | |
| Overall Study | COMPLETED | Sequence A | 10 | |
| Overall Study | COMPLETED | Sequence B | 14 | |
| Overall Study | COMPLETED | Sequence C | 8 | |
| Overall Study | COMPLETED | Sequence D | 12 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | EYE HAEMORRHAGE | Eye disorders | KVD900 300 mg | 0 | 86 | 0 |
| other | EYE HAEMORRHAGE | Eye disorders | KVD900 600 mg | 0 | 93 | 0 |
| other | EYE HAEMORRHAGE | Eye disorders | Placebo | 1 | 83 | 1 |
| other | VOMITING | Gastrointestinal disorders | KVD900 300 mg | 1 | 86 | 1 |
| other | VOMITING | Gastrointestinal disorders | KVD900 600 mg | 1 | 93 | 1 |
| other | VOMITING | Gastrointestinal disorders | Placebo | 1 | 83 | 1 |
| other | NAUSEA | Gastrointestinal disorders | KVD900 300 mg | 0 | 86 | 0 |
| other | NAUSEA | Gastrointestinal disorders | KVD900 600 mg | 1 | 93 | 1 |
| other | NAUSEA | Gastrointestinal disorders | Placebo | 1 | 83 | 1 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | KVD900 300 mg | 0 | 86 | 0 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | KVD900 300 mg | 0 | 86 |
| Total, all-cause mortality | KVD900 600 mg | 0 | 93 |
| Total, all-cause mortality | Placebo | 0 | 83 |
| Total, other adverse events | KVD900 300 mg | 5 | 86 |
| Total, other adverse events | KVD900 600 mg | 6 | 93 |
| Total, other adverse events | Placebo | 13 | 83 |
| Total, serious adverse events | KVD900 300 mg | 1 | 86 |
| Total, serious adverse events | KVD900 600 mg | 2 | 93 |
| Total, serious adverse events | Placebo | 0 | 83 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05259917
GET https://conductscience.org/api/trials/v1/NCT05259917/events?page=2