Phase
Condition
Urticaria
Hereditary Angioedema
Allergy
Treatment
KVD900 300 mg
KVD900 600 mg
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Patients may roll over from KVD900-301.
Inclusion Criteria:
Confirmed diagnosis of HAE type I or II at any time in the medical history
Patient has had at least 2 documented HAE attacks within 3 months prior to theEnrollment Visit.
If a patient is receiving long-term prophylactic treatment with one of theprotocol-allowed therapies, they must have been on a stable dose and regimen for atleast 3 months prior to the Enrollment Visit (except for danazol, which requires astable dose and regimen for at least 6 months prior to the Enrollment Visit).
Male or female patients 12 years of age and older.
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 andstore IMP, and be able to read, understand, and complete the eDiary.
Investigator believes that the patient is willing and able to adhere to all protocolrequirements.
Patient provides signed informed consent or assent (when applicable). A parent orlegally authorized representative (LAR) must also provide signed informed consentwhen required.
Exclusion
Exclusion Criteria:
Discontinued from the KVD900-301 trial for reasons of noncompliance, withdrawal ofconsent, or safety.
Presence of any safety concerns that would preclude participation in the open-labeltrial as determined by the investigator.
Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1inhibitor 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 managementof HAE, in the opinion of the Investigator.
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.
Use of Angiotensin-converting enzyme (ACE) inhibitors within 7 days prior to theEnrollment Visit.
Any estrogen-containing medications with systemic absorption (such as oralcontraceptives including ethinylestradiol or hormonal replacement therapy) within 7days prior to the Enrollment Visit.
Inadequate organ function, including but not limited to:
Alanine aminotransferase (ALT) >2x Upper Limit 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 opinionof the Investigator, would jeopardize the safety of the patient by participating inthe trial.
History of substance abuse or dependence that would interfere with the completion ofthe trial, as determined by the Investigator.
Known hypersensitivity to KVD900 or to any of the excipients.
Participation in any gene therapy treatment or trial for HAE.
Participation in any interventional investigational clinical trial, including aninvestigational COVID-19 vaccine trial, within 4 weeks of the last dosing ofinvestigational drug prior to the Enrollment Visit.
Any pregnant or breastfeeding patient.
Study Design
Connect with a study center
KalVista Investigative Site
Campbelltown, 2560
AustraliaSite Not Available
KalVista Investigative Site
Campbelltown 2172586, 2560
AustraliaSite Not Available
KalVista Investigative Site
Wein, 1090
AustriaSite Not Available
KalVista Investigative Site
Sofia, 1431
BulgariaSite Not Available
KalVista Investigative Site
Sofia 727011, 1431
BulgariaSite Not Available
KalVista Investigative Site
Montreal 6077243, H2W 1R7
CanadaSite Not Available
KalVista Investigative Site
Montréal, H2W 1R7
CanadaSite Not Available
KalVista Investigative Site
Grenoble 3014728, 38043
FranceSite Not Available
KalVista Investigative Site
Grenoble Cedex 9, 38043
FranceSite Not Available
KalVista Investigative Site
Lille, 59037
FranceSite Not Available
KalVista Investigative Site
Lille 2998324, 59037
FranceSite Not Available
KalVista Investigative Site
Lille Cedex, 59037
FranceSite Not Available
KalVista Investigative Site
Paris, 75012
FranceSite Not Available
KalVista Investigative Site
Paris 2988507, 75012
FranceSite Not Available
KalVista Investigative Site
Berlin, 12203
GermanySite Not Available
KalVista Investigative Site
Berlin 2950159, 12203
GermanySite Not Available
KalVista Investigative Site
Frankfurt, 60590
GermanySite Not Available
KalVista Investigative Site
Frankfurt 2925536, 60590
GermanySite Not Available
KalVista Investigative Site
Mainz, 55131
GermanySite Not Available
KalVista Investigative Site
Mainz 2874225, 55131
GermanySite Not Available
KalVista Investigative Site
Morfelden-Walldorf, 64546
GermanySite Not Available
KalVista Investigative Site
Mörfelden-Walldorf 3272460, 64546
GermanySite Not Available
KalVista Investigative Site
Athens, 11521
GreeceSite Not Available
KalVista Investigative Site
Athens 264371, 11527
GreeceSite Not Available
KalVista Investigative Site
Budapest, 1088
HungarySite Not Available
KalVista Investigative Site
Budapest 3054643, 1088
HungarySite Not Available
KalVista Investigative Site
Haifa, 31048
IsraelSite Not Available
KalVista Investigative Site
Haifa 294801, 31048
IsraelSite Not Available
KalVista Investigative Site
Petach Tikvah, 4920235
IsraelSite Not Available
KalVista Investigative Site
Ramat Gan, 52621
IsraelSite Not Available
KalVista Investigative Site
Ramat Gan 293788, 52621
IsraelSite Not Available
KalVista Investigative Site
Tel Aviv, 64239
IsraelSite Not Available
KalVista Investigative Site
Tel Aviv 293397, 64239
IsraelSite Not Available
KalVista Investigative Site
Padova, 35128
ItalySite Not Available
KalVista Investigative Site
Padua 3171728, 35128
ItalySite Not Available
KalVista Investigative Site
Palermo, 90146
ItalySite Not Available
KalVista Investigative Site
Palermo 2523920, 90146
ItalySite Not Available
KalVista Investigative Site
Roma, 00133
ItalySite Not Available
KalVista Investigative Site
Roma 8957247, 00133
ItalySite Not Available
KalVista Investigative Site
San Donato Milanese, 20097
ItalySite Not Available
KalVista Investigative Site
San Donato Milanese 3168414, 20097
ItalySite Not Available
KalVista Investigative Site
Sapporo-city, Hokkaido 002-8072
JapanSite Not Available
KalVista Investigative Site
Sapporo 2128295, Hokkaido 2130037 002-8072
JapanSite Not Available
KalVista Investigative Site
Chiba 2113015, 260-8677
JapanSite Not Available
KalVista Investigative Site
Chiba-shi, 260-8677
JapanSite Not Available
KalVista Investigative Site
Hiroshima 1862415, 730-8518
JapanSite Not Available
KalVista Investigative Site
Hiroshima-shi, 730-8518
JapanSite Not Available
KalVista Investigative Site
Kawagoe-shi, 350-8550
JapanSite Not Available
KalVista Investigative Site
Maebashi 1857843, 371-8511
JapanSite Not Available
KalVista Investigative Site
Maebashi-city, 371-8511
JapanSite Not Available
KalVista Investigative Site
Soka-shi, 340-0041
JapanSite Not Available
KalVista Investigative Site
Takatsuki-shi, 569-8686
JapanSite Not Available
KalVista Investgative Site
Tokyo, 142-8666
JapanSite Not Available
KalVista Investgative Site
Tokyo 1850147, 142-8666
JapanSite Not Available
KalVista Investigative Site
Yokohama 1848354, 236-0004
JapanSite Not Available
KalVista Investigative Site
Yokohama-shi, 236-0004
JapanSite Not Available
KalVista Investigative Site
Amsterdam, 1105 AZ
NetherlandsSite Not Available
KalVista Investigative Site
Amsterdam 2759794, 1105 AZ
NetherlandsSite Not Available
KalVista Investigative Site
Auckland, 1023
New ZealandSite Not Available
KalVista Investigative Site
Auckland 2193733, 1023
New ZealandSite Not Available
KalVista Investigative Site
Skopje, 1000
North MacedoniaSite Not Available
KalVista Investigative Site
Skopje 785842, 1000
North MacedoniaSite Not Available
KalVista Investigative Site
Krakow 3094802, 31-503
PolandSite Not Available
KalVista Investigative Site
Kraków, 31-503
PolandSite Not Available
KalVista Investigative Site
Lodz 3093133, 92-213
PolandSite Not Available
KalVista Investigative Site
Łódź, 92-213
PolandSite Not Available
KalVista Investigative Site
Porto, 4200-319
PortugalSite Not Available
KalVista Investigative Site
Porto 2735943, 4200-319
PortugalSite Not Available
KalVista Investigative Site
Sângeorgiu De Mureş, 547530
RomaniaSite Not Available
KalVista Investigative Site
Sângeorgiu de Mureş 667034, 547530
RomaniaSite Not Available
KalVista Investigative Site
Riyadh, 11211
Saudi ArabiaSite Not Available
KalVista Investigative Site
Riyadh 108410, 11211
Saudi ArabiaSite Not Available
KalVista Investigative Site
Martin, 036 59
SlovakiaSite Not Available
KalVista Investigative Site
Martin 3058780, 036 59
SlovakiaSite Not Available
Kalvista Investigative Site
Cape Town, 7700
South AfricaSite Not Available
Kalvista Investigative Site
Cape Town 3369157, 7700
South AfricaSite Not Available
KalVista Investigative Site
Barcelona, 08035
SpainSite Not Available
KalVista Investigative Site
Barcelona 3128760, 08907
SpainSite Not Available
KalVista Investigative Site
Madrid, 28046
SpainSite Not Available
KalVista Investigative Site
Madrid 3117735, 28046
SpainSite Not Available
KalVista Investigative Site
Birmingham, B9 5SS
United KingdomSite Not Available
KalVista Investigative Site
Birmingham 2655603, B9 5SS
United KingdomSite Not Available
KalVista Investigative Site
Cambridge, CB2 0QQ
United KingdomSite Not Available
KalVista Investigative Site
Cambridge 2653941, CB2 0QQ
United KingdomSite Not Available
KalVista Investigative Site
Cardiff, CF14 4XW
United KingdomSite Not Available
KalVista Investigative Site
Cardiff 2653822, CF14 4XW
United KingdomSite Not Available
KalVista Investigative Site
Frimley, GU16 7UJ
United KingdomSite Not Available
KalVista Investigative Site
Frimley 2649052, GU16 7UJ
United KingdomSite Not Available
KalVista Investigative Site
Leeds, LS9 7TF
United KingdomSite Not Available
KalVista Investigative Site
Leeds 2644688, LS9 7TF
United KingdomSite Not Available
KalVista Investigative Site
London, NW3 2QG
United KingdomSite Not Available
KalVista Investigative Site
London 2643743, E1 2ES
United KingdomSite Not Available
KalVista Investigative Site
Scottsdale, Arizona 85251
United StatesSite Not Available
KalVista Investigative Site
Scottsdale 5313457, Arizona 5551752 85251
United StatesSite Not Available
KalVista Investigative Site
Little Rock, Arkansas 72205
United StatesSite Not Available
KalVista Investigative Site
Little Rock 4119403, Arkansas 4099753 72205
United StatesSite Not Available
KalVista Investigative Site
San Diego, California 92122
United StatesSite Not Available
KalVista Investigative Site
Santa Monica, California 90404
United StatesSite Not Available
KalVista Investigative Site
San Diego 5391811, California 5332921 92123
United StatesSite Not Available
KalVista Investigative Site
Santa Monica 5393212, California 5332921 90404
United StatesSite Not Available
KalVista Investigative Site
Centennial, Colorado 80112
United StatesSite Not Available
KalVista Investigative Site
Colorado Springs, Colorado 80907
United StatesSite Not Available
KalVista Investigative Site
Centennial 5416541, Colorado 5417618 80112
United StatesSite Not Available
KalVista Investigative Site
Colorado Springs 5417598, Colorado 5417618 80907
United StatesSite Not Available
KalVista Investigative Site
Evansville, Indiana 47715
United StatesSite Not Available
KalVista Investigative Site
Evansville 4257227, Indiana 4921868 47715
United StatesSite Not Available
KalVista Investigative Site
Overland Park, Kansas 66211
United StatesSite Not Available
KalVista Investigative Site
Overland Park 4276873, Kansas 4273857 66211
United StatesSite Not Available
KalVista Investigative Site
Louisville, Kentucky 40215
United StatesSite Not Available
KalVista Investigative Site
Louisville 4299276, Kentucky 6254925 40215
United StatesSite Not Available
KalVista Investigative Site
Chevy Chase, Maryland 20815
United StatesSite Not Available
KalVista Investigative Site
Chevy Chase 4351335, Maryland 4361885 20815
United StatesSite Not Available
KalVista Investigative Site
Plymouth, Minnesota 55446
United StatesSite Not Available
KalVista Investigative Site
Plymouth 5041926, Minnesota 5037779 55446
United StatesSite Not Available
KalVista Investigative Site
Saint Louis, Missouri 63141
United StatesSite Not Available
KalVista Investigative Site
St Louis 4407066, Missouri 4398678 63141
United StatesSite Not Available
KalVista Investigative Site
Charlotte, North Carolina 28277
United StatesSite Not Available
KalVista Investigative Site
Charlotte 4460243, North Carolina 4482348 28277
United StatesSite Not Available
KalVista Investigative Site
Cincinnati, Ohio 45236
United StatesSite Not Available
KalVista Investigative Site
Toledo, Ohio 43617
United StatesSite Not Available
KalVista Investigative Site
Cincinnati 4508722, Ohio 5165418 45236
United StatesSite Not Available
KalVista Investigative Site
Toledo 5174035, Ohio 5165418 43617
United StatesSite Not Available
KalVista Investigative Site
Hershey, Pennsylvania 17033
United StatesSite Not Available
KalVista Investigative Site
Hershey 5193342, Pennsylvania 6254927 17033
United StatesSite Not Available
KalVista Investigative Site
Dallas, Texas 75231
United StatesSite Not Available
KalVista Investigative Site
Dallas 4684888, Texas 4736286 75231
United StatesSite Not Available
KalVista Investgative Site
Layton, Utah 84041
United StatesSite Not Available
KalVista Investgative Site
Layton 5777107, Utah 5549030 84041
United StatesSite Not Available
KalVista Investigative Site
Spokane, Washington 99204
United StatesSite Not Available
KalVista Investigative Site
Spokane 5811696, Washington 5815135 99204
United StatesSite Not Available

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