Hereditary AngioedemaPhase 3NCT05259917
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)
A Phase 3 study testing KVD900 600 mg and KVD900 300 mg in people with Hereditary Angioedema, run by KalVista Pharmaceuticals, Ltd. at 66 sites in 21 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hereditary Angioedema
- What is being tested?
- KVD900 600 mg and KVD900 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 66 sitesin 21 countries
- Study dates
- 22 Feb 2022to 31 Dec 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female patients 12 years of age and older.
- Confirmed diagnosis of HAE type I or II at any time in the medical history.
- Patient has access to and ability to use conventional on-demand treatment for HAE attacks.
- If a patient is receiving long-term prophylactic treatment with one of the protocol-allowed therapies, they must be on a stable dose and regimen for at least 3 months prior to the Screening Visit (except for danazol, which requires a stable dose and regimen for 6 months prior to the Screening Visit). Patient must be willing to remain on a stable dose and regimen for the duration of the trial.
- Patient's last dose of attenuated androgens other than danazol was at least 28 days prior to randomization.
- Patient:
Show all 13Show fewer
- has had at least 2 documented HAE attacks within 3 months prior to screening or randomization; or
- is a completer of the KVD824-201 trial within 3 months prior to randomization and meets all other entry criteria to enroll in KVD900-301
- Patients must meet the contraception requirements.
- Patients must be able to swallow trial tablets whole.
- Patients, as assessed by the Investigator, must be able to appropriately receive and store IMP, and be able to read, understand, and complete the electronic diary (eDiary).
- Investigator believes that the patient is willing and able to adhere to all protocol requirements.
- Patient provides signed informed consent or assent (when applicable). A parent or legally authorized representative (LAR) must also provide signed informed consent when required.
Who cannot join
- Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1-inhibitor deficiency, HAE with normal C1-INH (previously known as HAE type III), idiopathic angioedema, or angioedema associated with urticaria.
- A clinically significant history of poor response to bradykinin receptor 2 (BR2) blocker, C1-INH therapy or plasma kallikrein inhibitor therapy for the management of HAE, in the opinion of the Investigator.
- Use of angiotensin-converting enzyme (ACE) inhibitors after the Screening Visit or within 7 days prior to randomization.
- Any estrogen containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) within 7 days prior to the Screening Visit.
- Patients who require sustained use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers.
- Inadequate organ function, including but not limited to:
Show all 18Show fewer
- Alanine aminotransferase (ALT) >2x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) >2x ULN
- Bilirubin direct >1.25x ULN
- International normalized ratio (INR) >1.2
- Clinically significant hepatic impairment defined as a Child-Pugh B or C
- Any clinically significant comorbidity or systemic dysfunction, which in the opinion of the Investigator, would jeopardize the safety of the patient by participating in the trial.
- History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator.
- Known hypersensitivity to KVD900 or placebo or to any of the excipients.
- Prior participation in trial KVD900-201.
- Participation in any gene therapy treatment or trial for HAE.
- Participation in any interventional investigational clinical trial (with the exception of KVD824-201), including an investigational COVID-19 vaccine trial, within 4 weeks of the last dosing of investigational drug prior to screening.
- Any pregnant or breastfeeding patient.
Trial locations and contacts
66 sites in 21 countries.
66 sites in 21 countries
United States22 sites
KalVista Investigative Site
Birmingham, Alabama, 35209
KalVista Investigative Site
Centennial, Colorado, 80112
KalVista Investigative Site
Charlotte, North Carolina, 28277
KalVista Investigative Site
Chevy Chase, Maryland, 20815
KalVista Investigative Site
Chicago, Illinois, 60612
KalVista Investigative Site
Colorado Springs, Colorado, 80907
KalVista Investigative Site
Dallas, Texas, 75231
KalVista Investigative Site
Hershey, Pennsylvania, 17033
KalVista Investigative Site
Layton, Utah, 84041
KalVista Investigative Site
Little Rock, Arkansas, 72205
KalVista Investigative Site
Louisville, Kentucky, 40215
KalVista Investigative Site
New York, New York, 10029
KalVista Investigative Site
Overland Park, Kansas, 66211
KalVista Investigative Site
Plymouth, Minnesota, 55446
KalVista Investigative Site
San Diego, California, 92122
KalVista Investigative Site
San Diego, California, 92123
KalVista Investigative Site
Santa Monica, California, 90404
KalVista Investigative Site
Scottsdale, Arizona, 85251
KalVista Investigative Site
Spokane, Washington, 99202
KalVista Investigative Site
St Louis, Missouri, 61414
KalVista Investigative Site
Tampa, Florida, 33613
KalVista Investigative Site
Toledo, Ohio, 43617
Japan6 sites
KalVista Investgative Site
Chiba, 260-8677
KalVista Investigative Site
Gunma, 371-8511
KalVista Investigative Site
Hiroshima, 730-8518
KalVista Investigative Site
Saitama, 340-0041
KalVista Investgative Site
Takatsuki-shi, Osaka, 569-8686
KalVista Investigative Site
Yokohama, 236-0004
United Kingdom5 sites
KalVista Investigative Site
Birmingham, B9 5SS
KalVista Investigative Site
Cardiff, CF14 4XW
KalVista Investigative Site
Frimley, GU16 7UJ
KalVista Investigative Site
Leeds, LS9 7TF
KalVista Investigative Site
London, E1 1FR
France4 sites
KalVista Investigative Site
Grenoble, 38043
KalVista Investigative Site
Lille, 59000
KalVista Investigative Site
Lille, 59037
KalVista Investigative Site
Paris, 75571
Germany4 sites
KalVista Investigative Site
Berlin, 12203
KalVista Investigative Site
Frankfurt am Main, Hesse, 60590
KalVista Investigative Site
Mainz, 55131
KalVista Investigative Site
Mörfelden-Walldorf, 64546
Israel4 sites
KalVista Investigative Site
Haifa, 31048
KalVista Investigative Site
Petach Tikvah, 49202
KalVista Investigative Site
Ramat Gan, 52621
KalVista Investigative Site
Tel Aviv, 64239
Poland3 sites
KalVista Investigative Site
Bialystok, 15-276
KalVista Investigative Site
Krakow, 31-503
KalVista Investigative Site
Lodz, 92-213
Spain3 sites
KalVista Investigative Site
Barcelona, 08035
KalVista Investigative Site
Barcelona, 08907
KalVista Investigative Site
Madrid, 28046
Greece2 sites
Kalvista Investigative Site
Athens, 11521
KalVista Investigative Site
Athens, 11527
Italy2 sites
KalVista Investigative Site
Padova, 35128
KalVista Investigative Site
San Donato Milanese, 20097
Australia1 site
KalVista Investigative Site
Campbelltown, New South Wales, 2560
Romania1 site
KalVista Investigative Site
Sângeorgiu de Mureş, Mureș County, 547530
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema Type I or II
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
- Conditions
- Hereditary Angioedema
- Being tested
- Placebo, KVD900 600 mg, KVD900 300 mg
- Keywords
- KONFIDENT, Sebetralstat
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo to KVD900 Tablet
KVD900 600 mgDrug
KVD900 Tablet 600 mg (2 x 300 mg)
KVD900 300 mgDrug
KVD900 Tablet 300 mg (1 x 300 mg)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| KVD900 600 mg | Experimental | Not described Receives: Drug: KVD900 600 mg |
| KVD900 300 mg | Experimental | Not described Receives: Drug: KVD900 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 12 hours of the first investigational medicinal product (IMP) administration.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Within 24 hours of the first IMP administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start22 Feb 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hereditary AngioedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, KalVista Pharmaceuticals, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259917
- Sponsor's protocol ID
- KVD900-301
- Status last verified
- Apr 2025
- First submitted
- 4 Feb 2022
- Last updated
- 2 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared until all global regulatory filings are complete
Publications
Riedl MA, Farkas H, Aygoren-Pursun E, Psarros F, Soteres DF, Staevska M, Cancian M, Hagin D, Honda D, Melamed I, Savic S, Stobiecki M, Busse PJ, Dias de Castro E, Agmon-Levin N, Gower R, Kessel A, Kurowski M, Lleonart R, Grivcheva Panovska V, Wedner HJ, Audhya PK, Hao J, Iverson M, Smith MD, Yea CM, Lumry WR, Zanichelli A, Bernstein JA, Maurer M, Cohn DM; KONFIDENT Investigators. Oral Sebetralstat for On-Demand Treatment of Hereditary Angioedema Attacks. N Engl J Med. 2024 Jul 4;391(1):32-43. doi: 10.1056/NEJMoa2314192. Epub 2024 May 31.
PubMed 38819658Aygoren-Pursun E, Cohn DM, Agmon-Levin N, Banerji A, Bernstein JA, Busse P, Cancian M, de Castro ED, Farkas H, Grivcheva-Panovska V, Hagin D, Hakl R, Honda D, Kessel A, Kinaciyan T, Ifaad, Kurowski M, Li HH, Lleonart R, Longhurst HJ, Lumry WR, Magerl M, Martinez-Saguer I, Melamed I, Psarros F, Savic S, Soteres DF, Staevska M, Stobiecki M, Wedner HJ, Zanichelli A, Hao J, Patil K, Iverson M, Owiredu-Yeboa S, Smith MD, Yea CM, Audhya PK, Riedl MA, Kiani-Alikhan S, Maurer M. Sebetralstat for on-demand treatment of hereditary angioedema: A pooled analysis of placebo-controlled clinical trials. World Allergy Organ J. 2026 Jun 9;19(7):101401. doi: 10.1016/j.waojou.2026.101401. eCollection 2026 Jul.
PubMed 42318595Farkas H, Anderson J, Bouillet L, Caballero T, Cancian M, Craig T, Fukunaga A, Grivcheva-Panovska V, Guilarte M, Honda D, Kanarek H, Kiani-Alikhan S, Kinaciyan T, Leguevaques D, Longhurst HJ, Magerl M, Manning ME, Martinez-Saguer I, Melamed I, O'Connor ME, Peter J, Savic S, Soteres DF, Staevska M, Staubach P, Stobiecki M, Tachdjian R, Valerieva A, Yong PFK, Hao J, Iverson M, Smith MD, Yea CM, Audhya PK, Aygoren-Pursun E, Bernstein JA, Cohn DM, Lumry WR, Riedl MA, Zanichelli A, Maurer M. Long-Term Safety and Effectiveness of Sebetralstat: Interim Analysis of KONFIDENT-S Open-label Extension. J Allergy Clin Immunol Pract. 2025 Nov;13(11):3094-3103.e5. doi: 10.1016/j.jaip.2025.08.020. Epub 2025 Aug 29.
PubMed 40886933Aygoren-Pursun E, Zanichelli A, Cohn DM, Cancian M, Hakl R, Kinaciyan T, Magerl M, Martinez-Saguer I, Stobiecki M, Farkas H, Kiani-Alikhan S, Grivcheva-Panovska V, Bernstein JA, Li HH, Longhurst HJ, Audhya PK, Smith MD, Yea CM, Maetzel A, Lee DK, Feener EP, Gower R, Lumry WR, Banerji A, Riedl MA, Maurer M. An investigational oral plasma kallikrein inhibitor for on-demand treatment of hereditary angioedema: a two-part, randomised, double-blind, placebo-controlled, crossover phase 2 trial. Lancet. 2023 Feb 11;401(10375):458-469. doi: 10.1016/S0140-6736(22)02406-0.
PubMed 36774155
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema Type I or II
- ClinicalTrials.gov ID
- NCT05259917
- Acronym / sponsor ID
- KVD900-301
- Conditions
- Hereditary Angioedema
- Keywords
- KONFIDENT, Sebetralstat
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Posted 19 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| KVD900 600 mg | Experimental | Drug: KVD900 600 mg |
| KVD900 300 mg | Experimental | Drug: KVD900 300 mg |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female patients 12 years of age and older.
- Confirmed diagnosis of HAE type I or II at any time in the medical history.
- Patient has access to and ability to use conventional on-demand treatment for HAE attacks.
- If a patient is receiving long-term prophylactic treatment with one of the protocol-allowed therapies, they must be on a stable dose and regimen for at least 3 months prior to the Screening Visit (except for danazol, which requires a stable dose and regimen for 6 months prior to the Screening Visit). Patient must be willing to remain on a stable dose and regimen for the duration of the trial.
- Patient's last dose of attenuated androgens other than danazol was at least 28 days prior to randomization.
Key exclusion criteria (18 listed)
- Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1-inhibitor deficiency, HAE with normal C1-INH (previously known as HAE type III), idiopathic angioedema, or angioedema associated with urticaria.
- A clinically significant history of poor response to bradykinin receptor 2 (BR2) blocker, C1-INH therapy or plasma kallikrein inhibitor therapy for the management of HAE, in the opinion of the Investigator.
- Use of angiotensin-converting enzyme (ACE) inhibitors after the Screening Visit or within 7 days prior to randomization.
- Any estrogen containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) within 7 days prior to the Screening Visit.
- Patients who require sustained use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo to KVD900 Tablet | Drug | Placebo |
| KVD900 600 mgKVD900 Tablet 600 mg (2 x 300 mg) | Drug | KVD900 600 mg |
| KVD900 300 mgKVD900 Tablet 300 mg (1 x 300 mg) | Drug | KVD900 300 mg |
Primary outcome
Time to Beginning of Symptom Relief Patient Global Impression of Change (PGI-C)
Time frame: 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.
2 secondary outcomes
Time to First Incidence of Decrease From Baseline Patient Global Impression of Severity (PGI-S) (2 Time Points in a Row)
Time frame: Within 12 hours of the first IMP administration.
Time to Complete HAE Attack Resolution (PGI-S)
Time frame: Within 24 hours of the first IMP administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38819658Riedl MA, Farkas H, Aygoren-Pursun E, Psarros F, Soteres DF, Staevska M, Cancian M, Hagin D, Honda D, Melamed I, Savic S, Stobiecki M, Busse PJ, Dias de Castro E, Agmon-Levin N, Gower R, Kessel A, Kurowski M, Lleonart R, Grivcheva Panovska V, Wedner HJ, Audhya PK, Hao J, Iverson M, Smith MD, Yea CM, Lumry WR, Zanichelli A, Bernstein JA, Maurer M, Cohn DM; KONFIDENT Investigators. Oral Sebetralstat for On-Demand Treatment of Hereditary Angioedema Attacks. N Engl J Med. 2024 Jul 4;391(1):32-43. doi: 10.1056/NEJMoa2314192. Epub 2024 May 31.
- Derived from this study: PubMed 42318595Aygoren-Pursun E, Cohn DM, Agmon-Levin N, Banerji A, Bernstein JA, Busse P, Cancian M, de Castro ED, Farkas H, Grivcheva-Panovska V, Hagin D, Hakl R, Honda D, Kessel A, Kinaciyan T, Ifaad, Kurowski M, Li HH, Lleonart R, Longhurst HJ, Lumry WR, Magerl M, Martinez-Saguer I, Melamed I, Psarros F, Savic S, Soteres DF, Staevska M, Stobiecki M, Wedner HJ, Zanichelli A, Hao J, Patil K, Iverson M, Owiredu-Yeboa S, Smith MD, Yea CM, Audhya PK, Riedl MA, Kiani-Alikhan S, Maurer M. Sebetralstat for on-demand treatment of hereditary angioedema: A pooled analysis of placebo-controlled clinical trials. World Allergy Organ J. 2026 Jun 9;19(7):101401. doi: 10.1016/j.waojou.2026.101401. eCollection 2026 Jul.
- Derived from this study: PubMed 40886933Farkas H, Anderson J, Bouillet L, Caballero T, Cancian M, Craig T, Fukunaga A, Grivcheva-Panovska V, Guilarte M, Honda D, Kanarek H, Kiani-Alikhan S, Kinaciyan T, Leguevaques D, Longhurst HJ, Magerl M, Manning ME, Martinez-Saguer I, Melamed I, O'Connor ME, Peter J, Savic S, Soteres DF, Staevska M, Staubach P, Stobiecki M, Tachdjian R, Valerieva A, Yong PFK, Hao J, Iverson M, Smith MD, Yea CM, Audhya PK, Aygoren-Pursun E, Bernstein JA, Cohn DM, Lumry WR, Riedl MA, Zanichelli A, Maurer M. Long-Term Safety and Effectiveness of Sebetralstat: Interim Analysis of KONFIDENT-S Open-label Extension. J Allergy Clin Immunol Pract. 2025 Nov;13(11):3094-3103.e5. doi: 10.1016/j.jaip.2025.08.020. Epub 2025 Aug 29.
- Derived from this study: PubMed 36774155Aygoren-Pursun E, Zanichelli A, Cohn DM, Cancian M, Hakl R, Kinaciyan T, Magerl M, Martinez-Saguer I, Stobiecki M, Farkas H, Kiani-Alikhan S, Grivcheva-Panovska V, Bernstein JA, Li HH, Longhurst HJ, Audhya PK, Smith MD, Yea CM, Maetzel A, Lee DK, Feener EP, Gower R, Lumry WR, Banerji A, Riedl MA, Maurer M. An investigational oral plasma kallikrein inhibitor for on-demand treatment of hereditary angioedema: a two-part, randomised, double-blind, placebo-controlled, crossover phase 2 trial. Lancet. 2023 Feb 11;401(10375):458-469. doi: 10.1016/S0140-6736(22)02406-0.
- Individual participant dataSharing planned: No. Data will not be shared until all global regulatory filings are complete
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
KalVista Pharmaceuticals, Ltd.
66 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KVD900 600 mg and KVD900 300 mg in people with Hereditary Angioedema, run by KalVista Pharmaceuticals, Ltd. at 66 sites in 21 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, Japan, United Kingdom, France, Germany and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Beginning of Symptom Relief Patient Global Impression of Change (PGI-C) (time frame: Within 12 hours of the first investigational medicinal product (IMP) administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05259917, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.