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    Summary
    EudraCT Number:2018-004675-13
    Sponsor's Protocol Code Number:WIL-31
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-04-05
    Trial results View 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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2018-004675-13
    A.3Full title of the trial
    CLINICAL STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF WILATE
    DURING PROPHYLAXIS IN PREVIOUSLY TREATED PATIENTS WITH VON WILLEBRAND DISEASE (VWD)
    Profilaxis során alkalmazott Wilate hatékonyságának és biztonságosságának klinikai vizsgálata korábban már kezelt von-Willebrand betegséggel rendelkező betegeknél
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to investigate the study drug (WILATE) in patients with Von Willebrand Disease.
    Tanulmány a vizsgálati készítmény (WILATE) vizsgálatára von-Willebrand betegséggel rendelkező betegeknél
    A.4.1Sponsor's protocol code numberWIL-31
    A.5.4Other Identifiers
    Name:INDNumber:011303
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOctapharma AG
    B.1.3.4CountrySwitzerland
    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 supportOctapharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOctapharma AG
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressSeidenstrasse 2
    B.5.3.2Town/ cityLachen
    B.5.3.3Post codeCH-8853
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041554512184
    B.5.5Fax number0041554512110
    B.5.6E-mailIrena.Dzhunova@octapharma.ch
    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 Yes
    D.2.1.1.1Trade name Wilate 500
    D.2.1.1.2Name of the Marketing Authorisation holderOctapharma Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameWilate
    D.3.4Pharmaceutical form Lyophilisate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Coagulation Factor VIII, Von Willebrand Factor Complex
    D.3.9.2Current sponsor codeWILATE
    D.3.9.3Other descriptive nameHUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX
    D.3.9.4EV Substance CodeSUB78203
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 Yes
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Wilate 1000
    D.2.1.1.2Name of the Marketing Authorisation holderOctapharma Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameWilate
    D.3.4Pharmaceutical form Lyophilisate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Coagulation Factor VIII, Von Willebrand Factor Complex
    D.3.9.2Current sponsor codeWILATE
    D.3.9.3Other descriptive nameHUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX
    D.3.9.4EV Substance CodeSUB78203
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 Yes
    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
    Von Willebrand disease, type 3, type 2 (except 2N), or severe type 1
    Von Willebrand betegség, 3. típus, 2. típus (kivéve 2N), vagy súlyos 1. típus
    E.1.1.1Medical condition in easily understood language
    Von Willebrand disease (VWD) is an inherited condition that can sometimes cause heavy bleeding.
    A Von Willebrand betegség (VWD) egy örökletes állapot, ami néha súlyos vérzést okozhat.
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10055168
    E.1.2Term Von Willebrand's factor deficiency
    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
    The primary objective of this study is to determine the efficacy of Wilate in the prophylactic treatment of previously treated patients with type 3, type 2 (except 2N), or severe type 1 VWD
    A jelen vizsgálat elsődleges célkitűzése a profilaktikus kezelésként alkalmazott Wilate hatásosságának meghatározása a 3-as, 2-es (kivéve 2N) vagy súlyos 1-es típusú VWD-ben szenvedő, korábban kezelt betegeknél
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to:
    - Assess the VWF:Ac and VWF:Ag incremental IVR of Wilate over time (at baseline and at 3, 6, 9, and 12 months of treatment)
    - Assess the safety and tolerability of Wilate
    Jelen vizsgálat másodlagos célkitűzései:
    - A Wilate VWF:Ac és a VWF:Ag inkrementális kockáztatott értékének (IVR) értékelése az idő során függvényében (a kiinduláskor, valamint a kezelés 3., 6., 9. és 12. hónapjában)
    - A Wilate biztonságosságának és tolerálhatóságának értékelése.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients aged ≥6 years at the time of screening
    2. VWD type 1 (baseline von Willebrand factor activity [VWF:Ac], ristocetin-based, <30 IU/dL), 2A, 2B, 2M, or 3 according to medical history requiring substitution therapy with a VWF-containing product to control bleeding
    3. Currently receiving on-demand treatment with a VWF-containing product, with at least 1, and an average of ≥2, documented spontaneous BEs per month in the last 6 months requiring treatment with a VWF-containing product
    4. Availability of records to reliably evaluate type, frequency, and treatment of BEs for 6 months of on-demand treatment before screening
    5. Female patients of child-bearing potential must have a negative urine pregnancy test at screening and agree to use adequate birth control measures; in case hormonal contraception is used, the medication class should remain unchanged for the duration of the study
    6. Voluntarily given, fully informed written and signed consent obtained before any study-related procedures are conducted
    1 szűrés idején ≥6 éves betegek.
    2 1. es típusú (a kiindulási von Willebrand-faktor aktivitás [VWF:Ac], risztocetin alap, <30 NE/dl), 2A, 2B, 2M vagy 3-as típusú, a kórtörténet alapján VWF-t tartalmazó készítménnyel a vérzés kontrollálása céljából szubsztitúciós kezelést igénylő VWD.
    3 Aktuálisan VWF-t tartalmazó készítménnyel, igény szerinti kezelésben részesül, és legalább 1, de átlagosan ≥2, dokumentált, spontán BE történt havonta, az elmúlt 6 hónap során, amelyeknél VWF-t tartalmazó készítménnyel történő kezelés volt szükséges.
    4 Azon adatoknak rendelkezésre kell állniuk, amelyek alapján megbízhatóan meg lehet ítélni a BE-k típusát, gyakoriságát és kezelését a szűrést megelőző 6 hónapon keresztül történő, igény szerinti kezelés vonatkozásában.
    5 A fogamzóképes nőbetegeknek vizeletből végzett negatív terhességi teszteredménnyel kell rendelkezniük a szűrés alkalmával, és bele kell egyezniük megfelelő születésszabályozó módszerek alkalmazásába. Amennyiben hormonális fogamzásgátlást alkalmaz, akkor a gyógyszercsoportot változatlanul kell hagyni a vizsgálat ideje alatt.
    6 Teljes tájékoztatást követően, önkéntesen adott, aláírással igazolt írásbeli beleegyezés szükséges minden beteg részéről, mielőtt a vizsgálattal kapcsolatos bármilyen eljárást végeznének.
    E.4Principal exclusion criteria
    1. Patients currently on prophylaxis or having received prophylaxis within 6 months before screening (as well as patients having received treatment once a month for menstrual bleeding, but not for any other bleeding)
    2. History, or current suspicion, of VWF or FVIII inhibitors
    3. Medical history of a thromboembolic event within 1 year before enrolment
    4. Severe liver or kidney diseases (alanine aminotransferase [ALAT] and aspartate transaminase [ASAT] levels >5 times of upper limit of normal, creatinine >120 µmol/L)
    5. Platelet count <100,000/mL at screening (except for VWD type 2B)
    6. Patients receiving, or scheduled to receive, immunomodulating drugs (other than an-tiretroviral chemotherapy), such as alpha-interferon, prednisone (equivalent to >10 mg/day), or similar drugs
    7. Pregnant or breast-feeding at the time of enrolment
    8. Change in hormonal contraception within 6 months before enrolment
    9. Cervical or uterine conditions causing abnormal uterine bleeding (including infection, dysplasia)
    10. Treatment with any investigational medicinal product (IMP) in another interventional clinical study currently or within 4 weeks before enrolment
    11. Other coagulation disorders or bleeding disorders due to anatomical reasons
    12. Known hypersensitivity to any of the components of the study drug
    1. Aktuálisan profilaxisban részesülő vagy a szűrést megelőzően profilaxisban részesített betegek (továbbá azon betegek, akik havonta egyszer a menstruációs vérzés kapcsán, de más vérzés kapcsán nem részesültek kezelésben).
    2. A kórtörténetben szereplő, vagy a gyanú szerint aktuálisan meglévő VWF vagy FVIII inhibitorok
    3. A kórtörténetben szereplő tromboembóliás esemény a bevonás előtti 1 évben.
    4. Súlyos máj- vagy vesebetegség (az alanin-aminotranszferáz [ALAT] és az aszpartát-aminotranszferáz [ASAT] szintje a normáltartomány felső határértéknek 5-szörösét meghaladja, a kreatininszint >120 µmol/l)
    5. Vérlemezkeszám a szűréskor <100 000 /ml (kivétel a 2B típusú VWD esetén)
    6. Az immunmoduláns gyógyszereket kapó vagy a későbbiekben terv szerint kapó betegek (az antiretrovirális kemoterápia kivételével), úgymint alfa-interferon, prednizon (illetve >10 mg/nap prednizonnal egyenértékű) vagy hasonló gyógyszerek
    7. A bevonás idején terhes vagy szoptató nők
    8. A hormonális fogamzásgátlásban történt változás a bevonás előtti 6 hónapban
    9. Olyan méhnyak- vagy méhrendellenességek, amelyek rendellenes méhből származó vérzést okoznak (ideértve a fertőzéseket és a diszpláziát)
    10. Másik, beavatkozással járó klinikai vizsgálatban, bármilyen vizsgálati készítménnyel történő kezelés aktuálisan vagy a bevonás előtti 4 hétben
    11. Egyéb véralvadási rendellenességek vagy anatómiai okokból fakadó vérzési rendellenességek
    12. Ismert túlérzékenység a vizsgálati készítmény bármely összetevőjére
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is to demonstrate that the total annualised bleeding rate (TABR) during prophylactic treatment with Wilate lowers the patients’ TABR observed during on-demand treatment by more than 50%.
    A jelen vizsgálat elsődleges végpontja annak igazolása, hogy az egy évre vetített, összesített vérzési ráta (total annualised bleeding rate, TABR) a Wilate-tal végzett profilaktikus kezelés során több mint 50%-os csökkenést mutat az igény szerint kezelt betegek TABR-jéhez viszonyítva.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 3, 6, 9 and 12 months
    kiinduláskor, valamint a kezelés 3., 6., 9. és 12. hónapjában
    E.5.2Secondary end point(s)
    - Spontaneous annualised bleeding rate (SABR)
    - Wilate consumption data (VWF/FVIII IU/kg per month per patient) for prophylaxis
    - Incremental VWF:Ac and VWF:Ag IVR of Wilate over time (at baseline and at 3, 6, 9, and 12 months of treatment)
    - Safety and tolerability of Wilate by monitoring adverse events (AEs) throughout the study
    - Egy évre vetített spontán vérzési ráta (spontaneous annualised bleeding rate, SABR).
    - A profilaxis céljából alkalmazott Wilate felhasználási adatok (VWF/FVIII NE/kg per hó, per beteg).
    - A Wilate VWF:Ac és a VWF:Ag inkrementális kockáztatott értékének (IVR) értékelése az idő függvényében (a kiinduláskor, valamint a kezelés 3., 6., 9. és 12. hónapjában).
    - A Wilate biztonságossága és tolerálhatósága a vizsgálat során előforduló nemkívánatos események (adverse events, AEs) monitorozásával.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, 3, 6, 9 and 12 months
    kiinduláskor, valamint a kezelés 3., 6., 9. és 12. hónapjában
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 Yes
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 EEA5
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belarus
    Bulgaria
    Croatia
    Czech Republic
    Hungary
    Lebanon
    Russian Federation
    Ukraine
    United States
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 2
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 2
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 2
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 21
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children aged 6 or over
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 28
    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)
    Standard of care treatment
    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 Decision2019-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-04-23
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