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    Summary
    EudraCT Number:2021-001176-42
    Sponsor's Protocol Code Number:KVD900-302
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-10-04
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-001176-42
    A.3Full title of the trial
    An Open-label Extension Trial to Evaluate the Long-term Safety 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
    Sperimentazione di estensione in aperto per valutare la sicurezza a lungo termine di KVD900, un inibitore orale della callicreina plasmatica, per il trattamento al bisogno di attacchi di angioedema in pazienti adolescenti e adulti affetti da angioedema ereditario di tipo I o II
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A long-term study to evaluate if KVD900 is safe and effective in treating attacks in patients with Hereditary Angioedema.
    Studio a lungo termine per valutare se KVD900 sia sicuro ed efficace nel trattamento degli attacchi in pazienti con angioedema ereditario.
    A.3.2Name or abbreviated title of the trial where available
    KONFIDENT-S
    KONFIDENT-S
    A.4.1Sponsor's protocol code numberKVD900-302
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/416/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKalVista Pharmaceuticals Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKalVista Pharmaceuticals Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKalVista Pharmaceuticals Ltd
    B.5.2Functional name of contact pointKalVista Clinical
    B.5.3 Address:
    B.5.3.1Street AddressPorton Science Park, Bybrook Road
    B.5.3.2Town/ cityPorton Down, Salisbury
    B.5.3.3Post codeSP4 0BF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441980753002
    B.5.6E-mailclinicalstudies@kalvista.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/22/2625
    D.3 Description of the IMP
    D.3.1Product nameKVD900 300 mg Film Coated Tablet
    D.3.2Product code [KVD900]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsebetralstat
    D.3.9.2Current sponsor codeKVD900
    D.3.9.3Other descriptive nameKVD900
    D.3.9.4EV Substance CodeSUB190449
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hereditary Angioedema Type I or II
    Angioedema ereditario di tipo I e II
    E.1.1.1Medical condition in easily understood language
    Hereditary Angioedema is a genetic condition characterised by swelling of tissues. These swellings can occur on any part of the body.
    L’angioedema ereditario è una condizione genetica caratterizzata da gonfiore dei tessuti. Questo gonfiore può manifestarsi in qualsiasi parte del corpo.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10080956
    E.1.2Term Hereditary angioedema type I
    E.1.2System Organ Class 100000004850
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.0
    E.1.2Level LLT
    E.1.2Classification code 10080960
    E.1.2Term Hereditary angioedema type II
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety of long-term administration of KVD900 in adolescent and adult patients with HAE type I or II.
    Valutare la sicurezza della somministrazione a lungo termine di KVD900 in pazienti adolescenti e adulti affetti da angioedema ereditario (AE) di tipo I o II.
    E.2.2Secondary objectives of the trial
    -To assess the long-term efficacy of KVD900 in the treatment of attacks in adolescent and adult patients with HAE type I or II.

    -To assess the safety and efficacy of KVD900 when used as short-term prophylaxis in adolescent and adult patients with HAE types I or II.
    - Valutare l’efficacia a lungo termine di KVD900 nel trattamento degli attacchi in pazienti adolescenti e adulti con AE di tipo I o II.
    - Valutare la sicurezza e l’efficacia di KVD900 quando usato come trattamento profilattico a breve termine in pazienti adolescenti e adulti con AE di tipo I o II.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: A Pharmacokinetic Subtrial in Adolescent Patients with Hereditary Angioedema Type I or II Participating in the KVD900-302 Trial

    Version 2.0, Date 07 April 2022

    The objective of this subtrial is to investigate the pharmacokinetic (PK) profile of KVD900 in adolescent patients (12 to 17 years of age).

    This subtrial will not be conducted in Italy

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: -Sottosperimentazione di farmacocinetica in pazienti adolescenti affetti da angioedema ereditario di tipo I o II che partecipano alla sperimentazione KVD900-302

    -Versione 2.0, datata 07 aprile 2022

    -L’obiettivo di questa sottosperimentazione è studiare il profilo farmacocinetico (pharmacokinetic, [PK]) di KVD900 in pazienti adolescenti (da 12 a 17 anni di età).

    -Questa sottosperimentazione non sarà condotta in Italia.
    E.3Principal inclusion criteria
    Patients may roll over from KVD900-301.

    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 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 LAR must also provide signed informed consent when required.
    I pazienti possono effettuare il rollover dallo studio KVD900-301.


    1) Diagnosi confermata di AE di tipo I o II in qualsiasi momento nell’anamnesi medica.
    2) Il paziente ha avuto almeno 2 attacchi documentati di AE nei 3 mesi precedenti la visita di arruolamento.
    3) Se un paziente sta ricevendo un trattamento profilattico a lungo termine con una delle terapie consentite dal protocollo, deve aver mantenuto una dose e un regime stabili per almeno 6 mesi prima della visita di arruolamento.
    4) Pazienti ambosesso di età pari e superiore a 12 anni.
    5) I pazienti devono soddisfare i requisiti di contraccezione.
    6) I pazienti devono essere in grado di ingerire le compresse della sperimentazione per intero.
    7) I pazienti, secondo la valutazione dello sperimentatore, devono essere in grado di ricevere e conservare il medicinale sperimentale (Investigational Medicinal Product, [IMP]) in modo appropriato ed essere in grado di leggere, comprendere e compilare il diario elettronico (eDiary).
    8) Lo sperimentatore ritiene che il paziente sia disposto e in grado di ottemperare a tutti i requisiti del protocollo.
    9) Il paziente fornisce il consenso informato o l’assenso firmato (ove applicabile). Anche un genitore o rappresentante legale autorizzato (Legally Authorized Representative, [LAR]) deve fornire il consenso informato firmato quando richiesto.
    E.4Principal exclusion criteria
    1) Discontinued from the KVD900-301 trial for reasons of non-compliance, 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 attenuated androgens (e.g., stanozolol, danazol, oxandrolone, methyltestosterone, testosterone), or anti-fibrinolytics (e.g., tranexamic acid) within 28 days prior to the Enrollment Visit.
    6) Use of 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:
    a) Alanine aminotransferase (ALT) >2x ULN
    b) Aspartate aminotransferase (AST) >2x ULN
    c) Bilirubin direct >1.25x ULN
    d) INR >1.2
    e) 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.
    1) Ritiro dalla sperimentazione KVD900-301 per motivi di mancata conformità, revoca del consenso o sicurezza.
    2) Presenza di eventuali problemi di sicurezza che precluderebbero la partecipazione alla sperimentazione in aperto, come stabilito dallo sperimentatore.
    3) Qualsiasi diagnosi concomitante di un’altra forma di angioedema cronico, come deficit acquisito di inibitore di C1, AE con C1-INH normale (precedentemente noto come AE di tipo III), angioedema idiopatico o angioedema associato a orticaria.
    4) Un’anamnesi clinicamente significativa di scarsa risposta a un bloccante del recettore 2 della bradichinina (Bradykinin Receptor 2, [BR2]), alla terapia con C1-INH o alla terapia con inibitore della callicreina plasmatica per la gestione dell’AE, secondo il parere dello sperimentatore.
    5) Uso di androgeni attenuati (per es. stanozololo, danazolo, oxandrolone, metiltestosterone, testosterone) o anti-fibrinolitici (per es. acido tranexamico) nei 28 giorni precedenti la visita di arruolamento.
    6) Uso di inibitori dell’enzima di conversione dell’angiotensina (Angiotensin Converting Enzyme, [ACE]) nei 7 giorni precedenti la visita di arruolamento.
    7) Qualsiasi farmaco contenente estrogeni con assorbimento sistemico (come contraccettivi orali, tra cui etinilestradiolo o terapia sostitutiva ormonale) nei 7 giorni precedenti la visita di arruolamento.
    8) Funzione d’organo inadeguata, tra cui, a titolo esemplificativo ma non esaustivo:
    a) Alanina aminotransferasi (ALT) > 2 x limite superiore alla norma (Upper Limit of Normal, [ULN])
    b) Aspartato aminotransferasi (AST) > 2 x ULN
    c) Bilirubina diretta > 1,25 x ULN
    d) Rapporto normalizzato internazionale (International Normalized Ratio, [INR]) > 1,2
    e) Insufficienza epatica clinicamente significativa, definita come un punteggio Child-Pugh B o C
    9) Qualsiasi comorbilità o disfunzione sistemica clinicamente significativa che, a giudizio dello sperimentatore, comprometterebbe la sicurezza del paziente se partecipasse alla sperimentazione.
    10) Anamnesi di abuso di o dipendenza da sostanze che, secondo quanto stabilito dallo sperimentatore, interferirebbero con il completamento della sperimentazione.
    11) Ipersensibilità nota a KVD900 o a uno qualsiasi degli eccipienti.
    12) Partecipazione a qualsiasi trattamento di terapia genica o sperimentazione per l’AE.
    13) Partecipazione a qualsiasi sperimentazione clinica interventistica sperimentale, compresa una sperimentazione su un vaccino sperimentale anti-COVID-19, entro 4 settimane dall’ultima somministrazione del farmaco sperimentale prima della visita di arruolamento.
    14) Qualsiasi paziente in stato di gravidanza o allattamento.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients with at least one AE in adolescent and adult patients with HAE type I or II who have taken at least one dose of IMP.
    Percentuale di pazienti con almeno un EA in pazienti adolescenti e adulti con AE di tipo I o II che hanno assunto almeno una dose di IMP.
    E.5.1.1Timepoint(s) of evaluation of this end point
    AE's are assessed throughout the trial.
    Gli eventi avversi (EA) sono valutati per tutta la durata della sperimentazione.
    E.5.2Secondary end point(s)
    PGI-C: HAE attacks with symptom relief defined as at least '' a little better'' (2 time points in a row) within 12 hours of initial dose of IMP administration.
    PGI-S: HAE attacks with any decrease from baseline within 12 hours of initial dose of IMP administration.
    PGI-S: HAE attacks that resolved, defined as ''none'' within 24 hours of initial dose of IMP administration.
    Impressione globale del paziente sul cambiamento (Patient Global Impression of Change, [PGI-C]): attacchi di AE con sollievo dal sintomo definito come almeno “un po’ migliorato” (2 punti temporali consecutivi) entro 12 ore dalla somministrazione della dose iniziale di IMP.

    Impressione globale del paziente sulla gravità (Patient Global Impression of Severity, [PGI-S]): attacchi di AE con qualsiasi riduzione rispetto al basale entro 12 ore dalla somministrazione della dose iniziale di IMP.

    Impressione globale del paziente sulla gravità (PGI-S): attacchi di AE che si sono risolti, definiti come “nessuno” entro 24 ore dalla somministrazione della dose iniziale di IMP.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Within 12 hours of initial dose of IMP administration.
    - Within 12 hours of initial dose of IMP administration.
    - Within 24 hours of initial dose of IMP administration.
    - Entro 12 ore dalla somministrazione della dose iniziale di IMP.

    - Entro 12 ore dalla somministrazione della dose iniziale di IMP.

    - Entro 24 ore dalla somministrazione della dose iniziale di IMP.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Israel
    New Zealand
    Saudi Arabia
    South Africa
    United States
    Austria
    France
    Poland
    Bulgaria
    Netherlands
    Romania
    Spain
    Germany
    Greece
    Italy
    Hungary
    North Macedonia
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days6
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days22
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 134
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 150
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Following completion of the trial, patients who demonstrate clinical benefit will be eligible to continue receiving KVD900 at the request of their treating physician until KVD900 is commercially available in the patient's country. Continuation of KVD900 will be at the discretion of the Sponsor and in line with local laws/guidelines.
    Dopo il completamento della sperimentazione, i pazienti che dimostrano un beneficio clinico saranno idonei a continuare a ricevere KVD900 dietro richiesta del proprio medico curante fino a quando KVD900 sarà disponibile in commercio nel Paese del paziente. La continuazione di KVD900 sarà a discrezione dello Sponsor e in linea con le leggi/linee guida locali.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-02
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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