CClinicalTrials.gg
CompletedNCT05505916Updated Jun 5, 2026

An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)

A Phase 3 interventional study of KVD900 600 mg and KVD900 300 mg in Hereditary Angioedema, sponsored by KalVista Pharmaceuticals, Ltd.. Completed at 71 sites in 23 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by KalVista Pharmaceuticals, Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
145
Allocation
Non-randomized
Ages
12 Years and older
Sex
All
01

Study summary

This is an open-label, multicenter extension trial to evaluate the long-term safety of KVD900 in patients who are 12 years or older with HAE type I or II.

02

Conditions studied

  • Hereditary Angioedema

Keywords

  • KONFIDENT-S
  • Sebetralstat
03

In context

Angioedemas, Hereditary

171 studies on the registry are indexed under Angioedemas, Hereditary; 25 are open to participants now.

This study's enrollment of 145 is above the median of 53 across 115 interventional studies indexed under Angioedemas, Hereditary.

Browse Angioedemas, Hereditary studies →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Patients may roll over from KVD900-301.

Inclusion criteria

Inclusion Criteria:

  1. Confirmed diagnosis of HAE type I or II at any time in the medical history
  2. Patient has had at least 2 documented HAE attacks within 3 months prior to the Enrollment Visit.
  3. If a patient is receiving long-term prophylactic treatment with one of the protocol-allowed therapies, they must have been on a stable dose and regimen for at least 3 months prior to the Enrollment Visit (except for danazol, which requires a stable dose and regimen for at least 6 months prior to the Enrollment Visit).
  4. Male or female patients 12 years of age and older.
  5. Patients must meet the contraception requirements.
  6. Patients must be able to swallow trial tablets whole.
  7. Patients, as assessed by the Investigator, must be able to appropriately receive and store IMP, and be able to read, understand, and complete the eDiary.
  8. Investigator believes that the patient is willing and able to adhere to all protocol requirements.
  9. Patient provides signed informed consent or assent (when applicable). A parent or legally authorized representative (LAR) must also provide signed informed consent when required.

Exclusion criteria

Exclusion Criteria:

  1. Discontinued from the KVD900-301 trial for reasons of noncompliance, withdrawal of consent, or safety.
  2. Presence of any safety concerns that would preclude participation in the open-label trial as determined by the investigator.
  3. 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.
  4. 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.
  5. Use of attenuated androgens other than danazol (e.g., stanozolol, oxandrolone, methyltestosterone, testosterone), or anti-fibrinolytics (e.g., tranexamicacid) within 28 days prior to the Enrollment Visit.
  6. Use of Angiotensin-converting enzyme (ACE) inhibitors within 7 days prior to the Enrollment Visit.
  7. Any estrogen-containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) within 7 days prior to the Enrollment Visit.
  8. Inadequate organ function, including but not limited to:

    1. Alanine aminotransferase (ALT) >2x Upper Limit Normal (ULN)
    2. Aspartate aminotransferase (AST) >2x ULN
    3. Bilirubin direct >1.25x ULN
    4. International Normalized Ratio (INR) >1.2
    5. Clinically significant hepatic impairment defined as a Child-Pugh B or C
  9. 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.
  10. History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator.
  11. Known hypersensitivity to KVD900 or to any of the excipients.
  12. Participation in any gene therapy treatment or trial for HAE.
  13. Participation in any interventional investigational clinical trial, including an investigational COVID-19 vaccine trial, within 4 weeks of the last dosing of investigational drug prior to the Enrollment Visit.
  14. Any pregnant or breastfeeding patient.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
145 participants (actual)

Study arms

  • Experimental
    KVD900 600 mg

    Drug: KVD900 600 mg

  • Experimental
    KVD900 300 mg

    Drug: KVD900 300 mg

Interventions

  • DrugKVD900 600 mg

    KVD900 Tablet 600 mg (2 x 300 mg)

  • DrugKVD900 300 mg

    KVD900 Tablet 300 mg

06

What researchers measure

Primary outcomes

  1. Frequencies and percentages of patients with AEs, AEs within 2 days of IMP administration, serious AE's and AEs causing premature discontinuation.

    Time frame: 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.

  2. Number and percentage of patients with normal or abnormal laboratory results at each scheduled visit.

    Time frame: Throughout the duration of the trial.

  3. Number and percentage of patients with normal or abnormal vital sign results at each scheduled visit

    Time frame: Throughout the duration of the trial.

Secondary outcomes

  1. Patient Global Impression of Change (PGI-C).

    time to beginning of symptom relief defined as at least '' a little better'' (2 time points in a row)

    Time frame: within 12 hours of initial dose of IMP administration.

  2. Patient Global Impression of Severity (PGI-S): time to first incidence of 2 time points in a row decrease from baseline

    Time frame: within 12 hours of initial dose of IMP administration.

  3. PGI-S: time to HAE attack resolution

    PGI-S: time to HAE attack resolution, defines as ''none''

    Time frame: within 24 hours of initial dose of IMP administration.

07

Study locations

71 sites
  • KalVista Investigative Site
    Scottsdale, Arizona 85251, United States
  • KalVista Investigative Site
    Little Rock, Arkansas 72205, United States
  • KalVista Investigative Site
    San Diego, California 92122, United States
  • KalVista Investigative Site
    San Diego, California 92123, United States
  • KalVista Investigative Site
    Santa Monica, California 90404, United States
  • KalVista Investigative Site
    Centennial, Colorado 80112, United States
  • KalVista Investigative Site
    Colorado Springs, Colorado 80907, United States
  • KalVista Investigative Site
    Evansville, Indiana 47715, United States
  • KalVista Investigative Site
    Overland Park, Kansas 66211, United States
  • KalVista Investigative Site
    Louisville, Kentucky 40215, United States
  • KalVista Investigative Site
    Chevy Chase, Maryland 20815, United States
  • KalVista Investigative Site
    Plymouth, Minnesota 55446, United States
  • KalVista Investigative Site
    St Louis, Missouri 63141, United States
  • KalVista Investigative Site
    Charlotte, North Carolina 28277, United States
  • KalVista Investigative Site
    Cincinnati, Ohio 45236, United States
  • KalVista Investigative Site
    Toledo, Ohio 43617, United States
  • KalVista Investigative Site
    Hershey, Pennsylvania 17033, United States
  • KalVista Investigative Site
    Dallas, Texas 75231, United States
  • KalVista Investgative Site
    Layton, Utah 84041, United States
  • KalVista Investigative Site
    Spokane, Washington 99204, United States
  • KalVista Investigative Site
    Campbelltown, 2560, Australia
  • KalVista Investigative Site
    Wein, 1090, Austria
  • KalVista Investigative Site
    Sofia, 1431, Bulgaria
  • KalVista Investigative Site
    Montreal, H2W 1R7, Canada
  • KalVista Investigative Site
    Grenoble, 38043, France
  • KalVista Investigative Site
    Lille, 59037, France
  • KalVista Investigative Site
    Paris, 75012, France
  • KalVista Investigative Site
    Berlin, 12203, Germany
  • KalVista Investigative Site
    Frankfurt, 60590, Germany
  • KalVista Investigative Site
    Mainz, 55131, Germany
  • KalVista Investigative Site
    Mörfelden-Walldorf, 64546, Germany
  • KalVista Investigative Site
    Athens, 11521, Greece
  • KalVista Investigative Site
    Athens, 11527, Greece
  • KalVista Investigative Site
    Budapest, 1088, Hungary
  • KalVista Investigative Site
    Haifa, 31048, Israel
  • KalVista Investigative Site
    Petach Tikvah, 4920235, Israel
  • KalVista Investigative Site
    Ramat Gan, 52621, Israel
  • KalVista Investigative Site
    Tel Aviv, 64239, Israel
  • KalVista Investigative Site
    Padova, 35128, Italy
  • KalVista Investigative Site
    Palermo, 90146, Italy
  • KalVista Investigative Site
    Roma, 00133, Italy
  • KalVista Investigative Site
    San Donato Milanese, 20097, Italy
  • KalVista Investigative Site
    Sapporo, Hokkaido 002-8072, Japan
  • KalVista Investigative Site
    Chiba, 260-8677, Japan
  • KalVista Investigative Site
    Hiroshima, 730-8518, Japan
  • KalVista Investigative Site
    Kawagoe-shi, 350-8550, Japan
  • KalVista Investigative Site
    Maebashi, 371-8511, Japan
  • KalVista Investigative Site
    Soka-shi, 340-0041, Japan
  • KalVista Investigative Site
    Takatsuki-shi, 569-8686, Japan
  • KalVista Investgative Site
    Tokyo, 142-8666, Japan
  • KalVista Investigative Site
    Yokohama, 236-0004, Japan
  • KalVista Investigative Site
    Amsterdam, 1105 AZ, Netherlands
  • KalVista Investigative Site
    Auckland, 1023, New Zealand
  • KalVista Investigative Site
    Skopje, 1000, North Macedonia
  • KalVista Investigative Site
    Krakow, 31-503, Poland
  • KalVista Investigative Site
    Lodz, 92-213, Poland
  • KalVista Investigative Site
    Porto, 4200-319, Portugal
  • KalVista Investigative Site
    Sângeorgiu de Mureş, 547530, Romania
  • KalVista Investigative Site
    Riyadh, 11211, Saudi Arabia
  • KalVista Investigative Site
    Martin, 036 59, Slovakia
  • Kalvista Investigative Site
    Cape Town, 7700, South Africa
  • KalVista Investigative Site
    Barcelona, 08035, Spain
  • KalVista Investigative Site
    Barcelona, 08907, Spain
  • KalVista Investigative Site
    Madrid, 28046, Spain
  • KalVista Investigative Site
    Birmingham, B9 5SS, United Kingdom
  • KalVista Investigative Site
    Cambridge, CB2 0QQ, United Kingdom
  • KalVista Investigative Site
    Cardiff, CF14 4XW, United Kingdom
  • KalVista Investigative Site
    Frimley, GU16 7UJ, United Kingdom
  • KalVista Investigative Site
    Leeds, LS9 7TF, United Kingdom
  • KalVista Investigative Site
    London, E1 2ES, United Kingdom
  • KalVista Investigative Site
    London, NW3 2QG, United Kingdom
08

References and documents

Publications

  • Kinaciyan T, Aygoren-Pursun E, Martinez-Saguer I, Soteres DF, Honda D, Manning ME, Wedner HJ, Fukunaga A, Kanarek HJ, Ohmura K, Melamed I, El-Shanawany T, Bouillet L, Lumry WR, Riedl MA, Koleilat M, Geng B, Ohsawa I, Bara N, Rehman S, Bernstein JA, Busse PJ, Cancian M, Cohn DM, Craig TJ, Farkas H, Kiani-Alikhan S, Li HH, Raasch JP, Tachdjian R, Audhya PK, Bajcic P, Chuang YH, Iverson M, Smith MD, Yea CM, Zanichelli A. Sebetralstat for breakthrough attacks in patients with hereditary angioedema receiving long-term prophylaxis in KONFIDENT-S. J Allergy Clin Immunol Glob. 2026 Jun 12;5(5):100750. doi: 10.1016/j.jacig.2026.100750. eCollection 2026 Sep. PubMed 42436759 ↗
  • Bernstein JA, Aygoren-Pursun E, Cancian M, Cohn DM, Craig T, Grivcheva-Panovska V, Jordan A, Lumry WR, Martinez-Saguer I, Melamed I, Ohmura K, Peter J, Riedl MA, Soteres DF, Staubach P, Stobiecki M, Chuang YH, Smith MD, Yea CM, Audhya PK, Zanichelli A, Farkas H. Sebetralstat for On-Demand Treatment of Mucosal Hereditary Angioedema Attacks in KONFIDENT-S. Clin Transl Allergy. 2025 Nov;15(11):e70118. doi: 10.1002/clt2.70118. PubMed 41252457 ↗
  • Farkas 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 40886933 ↗

Individual participant data

Plan to share: No — Data will not be shared until all global regulatory filings are complete.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05505916
Lead sponsor
KalVista Pharmaceuticals, Ltd.
Responsible party
Sponsor
First posted
Aug 18, 2022
Start date
Oct 24, 2022
Primary completion
May 27, 2026
Completion
May 27, 2026
Last update
Jun 5, 2026

Study contacts

Study Director
study director · KalVista Pharmaceuticals, Ltd.

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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