A Phase 3 interventional study of Placebo and KVD900 600 mg in Hereditary Angioedema, sponsored by KalVista Pharmaceuticals, Ltd.. Completed at 66 sites in 21 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-05-02.
Sponsored by KalVista Pharmaceuticals, Ltd. (part of Chiesi Farmaceutici S.p.A.) · Phase 3, Interventional, and Treatment
Among 12 studies in Angioedemas, Hereditary by KalVista Pharmaceuticals, Ltd. — 1 open to participants now, 1 under way, none of them phase 3. Angioedemas, Hereditary · KalVista Pharmaceuticals, Ltd..
Among the 12 studies in Angioedemas, Hereditary by KalVista Pharmaceuticals, Ltd., this one is one of 3 that started in 2022, is one of 4 in phase 3, and was the 5th registered.
171 studies on the registry are indexed under Angioedemas, Hereditary; 24 are open to participants now.
Browse Angioedemas, Hereditary studies →1 of the 12 studies in Angioedemas, Hereditary by KalVista Pharmaceuticals, Ltd. is open now, in 1 country. Recruiting first, the newest first:
KalVista Pharmaceuticals, Ltd. · Sites in United States
By country, each count listing its studies:
Of the 13 Angioedemas, Hereditary studies recruiting now, 9 (69%) set no upper age limit and 4 (31%) stop at 75 or younger; 7 take children under 18; 1 take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 3 started in 2022.
This study's enrollment of 136 is above the median of 48 across 116 interventional studies indexed under Angioedemas, Hereditary.
Median enrollment 84 across the 9 interventional studies, 88 across the 1 observational. Of the 9 that completed or were terminated, 3 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
KalVista Pharmaceuticals, Ltd. is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
1 of the studies in Angioedemas, Hereditary by KalVista Pharmaceuticals, Ltd. that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07654829KalVista Pharmaceuticals, Ltd.Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in People With Hereditary Angioedema (KONTROL) | 2027-11-29 |
Among the 12 studies in Angioedemas, Hereditary by KalVista Pharmaceuticals, Ltd., from their registry updates:
Nothing recorded among them since 2026-09-25.
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This study is a randomized, double-blind, placebo-controlled, phase III, three-way crossover clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adolescent and adult Patients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient:
Exclusion Criteria:
Inadequate organ function, including but not limited to:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Placebo
Drug: KVD900 600 mg
Drug: KVD900 300 mg
Placebo to KVD900 Tablet
KVD900 Tablet 600 mg (2 x 300 mg)
KVD900 Tablet 300 mg (1 x 300 mg)
Time to Beginning of Symptom Relief Patient Global Impression of Change (PGI-C)
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.
Time frame: Within 12 hours of the first investigational medicinal product (IMP) administration.
Time to First Incidence of Decrease From Baseline Patient Global Impression of Severity (PGI-S) (2 Time Points in a Row)
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.
Time frame: Within 12 hours of the first IMP administration.
Time to Complete HAE Attack Resolution (PGI-S)
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.
Time frame: Within 24 hours of the first IMP administration.
A total of 158 patients were screened, of which 22 were screen failures. The majority of screen failures were due to inclusion criterion not met.
| Milestone | Sequence A | Sequence B | Sequence C | Sequence D | Sequence E | Sequence F |
|---|---|---|---|---|---|---|
| Started | 18 | 18 | 15 | 17 | 20 | 22 |
| Completed | 10 | 14 | 8 | 12 | 8 | 16 |
| Not completed | 8 | 4 | 7 | 5 | 12 | 6 |
| Withdrew: Protocol violation | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 0 | 0 | 1 |
| Withdrew: Physician decision | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 | 1 | 1 |
| Withdrew: Trial termination by sponsor | 7 | 2 | 3 | 5 | 11 | 4 |
| Withdrew: Other | 1 | 0 | 2 | 0 | 0 | 0 |
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.
| Time (h) | KVD900 300 mg | KVD900 600 mg | Placebo |
|---|---|---|---|
| Time to Beginning of Symptom Relief Patient Global Impression of Change (PGI-C) | 1.61 (1.28 to 2.27) | 1.79 (1.33 to 2.27) | 6.72 (2.33 to NA) |
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.
| Time (h) | KVD900 300 mg | KVD900 600 mg | Placebo |
|---|---|---|---|
| Time to First Incidence of Decrease From Baseline Patient Global Impression of Severity (PGI-S) (2 Time Points in a Row) | 9.27 (4.08 to NA) | 7.75 (3.27 to NA) | NA (NA to NA) |
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.
| Time (h) | KVD900 300 mg | KVD900 600 mg | Placebo |
|---|---|---|---|
| Time to Complete HAE Attack Resolution (PGI-S) | NA (16.60 to NA) | 24.00 (10.60 to NA) | NA (NA to NA) |
Collected over The period of observation for AEs extends from the time of the patient's first dose of IMP until the Final/ET Visit, an average of 18 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| KVD900 300 mg | 0/86 (0%) | 1/86 (1.2%) | 5/86 (5.8%) |
| KVD900 600 mg | 0/93 (0%) | 2/93 (2.2%) | 6/93 (6.5%) |
| Placebo | 0/83 (0%) | 0/83 (0%) | 13/83 (15.7%) |
| Event | KVD900 300 mg | KVD900 600 mg | Placebo |
|---|---|---|---|
| INTERVERTEBRAL DISC PROTRUSIONMusculoskeletal and connective tissue disorders | 1/86 | 0/93 | 0/83 |
| HEREDITARY ANGIOEDEMACongenital, familial and genetic disorders | 0/86 | 1/93 | 0/83 |
| ANISOCORIAEye disorders | 0/86 | 1/93 | 0/83 |
| Event | KVD900 300 mg | KVD900 600 mg | Placebo |
|---|---|---|---|
| HEADACHENervous system disorders | 0/86 | 3/93 | 1/83 |
| EYE HAEMORRHAGEEye disorders | 0/86 | 0/93 | 1/83 |
| VOMITINGGastrointestinal disorders | 1/86 | 1/93 | 1/83 |
| NAUSEAGastrointestinal disorders | 0/86 | 1/93 | 1/83 |
| ABDOMINAL PAINGastrointestinal disorders | 0/86 | 0/93 | 1/83 |
| FATIGUEGeneral disorders | 1/86 | 0/93 | 1/83 |
| INFLUENZAInfections and infestations | 0/86 | 0/93 | 1/83 |
| PHARYNGITIS BACTERIALInfections and infestations | 0/86 | 0/93 | 1/83 |
| NECK PAINMusculoskeletal and connective tissue disorders | 0/86 | 0/93 | 1/83 |
| DYSGEUSIANervous system disorders | 0/86 | 0/93 | 1/83 |
| Age, Continuous(years) | Sequence A | Sequence B | Sequence C | Sequence D | Sequence E | Sequence F | Total |
|---|---|---|---|---|---|---|---|
| Mean | 37.4 ± 15.70 | 35.8 ± 16.90 | 41.1 ± 17.87 | 31.8 ± 11.42 | 41.4 ± 14.60 | 38.2 ± 13.14 | 37.7 ± 14.96 |
| Sex: Female, Male(Participants) | Sequence A | Sequence B | Sequence C | Sequence D | Sequence E | Sequence F | Total |
|---|---|---|---|---|---|---|---|
| Female | 13 | 14 | 5 | 12 | 11 | 11 | 66 |
| Male | 5 | 4 | 10 | 5 | 9 | 11 | 44 |
| Ethnicity (NIH/OMB)(Participants) | Sequence A | Sequence B | Sequence C | Sequence D | Sequence E | Sequence F | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 3 | 1 | 2 | 0 | 7 |
| Not Hispanic or Latino | 15 | 17 | 10 | 15 | 17 | 21 | 95 |
| Unknown or Not Reported | 2 | 1 | 2 | 1 | 1 | 1 | 8 |
| Race (NIH/OMB)(Participants) | Sequence A | Sequence B | Sequence C | Sequence D | Sequence E | Sequence F | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 2 | 0 | 1 | 5 | 1 | 1 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| White | 14 | 18 | 12 | 11 | 18 | 19 | 92 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 1 | 1 | 1 | 2 | 7 |
| Height(meters) | Sequence A | Sequence B | Sequence C | Sequence D | Sequence E | Sequence F | Total |
|---|---|---|---|---|---|---|---|
| Mean | 1.646 ± 0.1216 | 1.694 ± 0.1135 | 1.715 ± 0.0877 | 1.657 ± 0.1205 | 1.686 ± 0.0884 | 1.704 ± 0.1126 | 1.684 ± 0.1088 |
| Weight(kilograms) | Sequence A | Sequence B | Sequence C | Sequence D | Sequence E | Sequence F | Total |
|---|---|---|---|---|---|---|---|
| Mean | 75.16 ± 16.109 | 73.88 ± 16.603 | 83.80 ± 18.157 | 72.28 ± 23.735 | 77.90 ± 16.321 | 83.55 ± 21.949 | 77.86 ± 19.179 |
| Body mass index(kg/m^2) | Sequence A | Sequence B | Sequence C | Sequence D | Sequence E | Sequence F | Total |
|---|---|---|---|---|---|---|---|
| Mean | 27.78 ± 5.638 | 25.62 ± 4.743 | 28.62 ± 6.603 | 26.15 ± 7.701 | 27.37 ± 5.162 | 28.90 ± 7.329 | 27.44 ± 6.261 |
| Treatment Regimen(Participants) | Sequence A | Sequence B | Sequence C | Sequence D | Sequence E | Sequence F | Total |
|---|---|---|---|---|---|---|---|
| Prophylaxis | 3 | 5 | 3 | 3 | 3 | 7 | 24 |
| On Demand Only | 15 | 13 | 12 | 14 | 17 | 15 | 86 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Data will not be shared until all global regulatory filings are complete
Ran from Feb 2022 to primary completion in Dec 2023, 22 months.
Results were first posted in Jul 2024, 6 months after primary completion.
Of 46 industry-sponsored phase 3 interventional studies under Angioedemas, Hereditary, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 33. This study's 22 months is close to that.
Counting every sponsor, half of 46 studies reached it within 22 months; a quarter within 16 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sebetralstat
KalVista Pharmaceuticals, Ltd. →