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    Summary
    EudraCT Number:2011-002403-15
    Sponsor's Protocol Code Number:Forma-01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-04-15
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-002403-15
    A.3Full title of the trial
    A prospective, controlled, randomised, cross-over study investigating the pharmacokinetic properties, surrogate efficacy and safety of Octafibrin
    compared to Haemocomplettan® P/ RiaSTAPTM in subjects with congenital fibrinogen deficiency
    Uno studio di cross-over prospettico, controllato, randomizzato che analizza le proprietà farmacocinetiche, l'efficacia e la sicurezza di Octafibrin rispetto a Haemocomplettan® P/ RiaSTAPTM in soggetti con deficit congenito di fibrinogeno
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A controlled, randomised, study investigating the
    pharmacokinetic properties (to see how active the study drug is in your blood and how long it takes for the study drug to get out of your blood) ,
    surrogate efficacy and safety of Octafibrin compared to
    Haemocomplettan® P/ RiaSTAPTM in subjects with congenital fibrinogen deficiency
    Uno studio controllato, randomizzato che analizza le proprietà farmacocinetiche (per vedere come agisce il farmaco in studio nel sangue e quanto tempo occorre prima che sia escreto dal sangue), l'efficacia e la sicurezza di Octafibrin rispetto a Haemocomplettan® P/ RiaSTAPTM in soggetti con deficit congenito di fibrinogeno
    A.4.1Sponsor's protocol code numberForma-01
    A.7Trial is part of a Paediatric Investigation Plan Yes
    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 supportOCTAPHARM
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBIOIKOS FARMA S.R.L.
    B.5.2Functional name of contact pointPROJECT MONITORING
    B.5.3 Address:
    B.5.3.1Street AddressVIA G. LEOPARDI N. 6
    B.5.3.2Town/ cityBOLOGNA
    B.5.3.3Post code40122
    B.5.3.4CountryItaly
    B.5.4Telephone number00390512966411
    B.5.5Fax number00390512966490
    B.5.6E-mailmorgagni@bioikos.it
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameoctafibrin
    D.3.4Pharmaceutical form Powder 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 FIBRINOGEN
    D.3.9.1CAS number 9001-32-5
    D.3.9.3Other descriptive nameHUMAN FIBRINOGEN
    D.3.9.4EV Substance CodeSUB12502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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 RoleComparator
    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 Haemocomplettan® P
    D.2.1.1.2Name of the Marketing Authorisation holderCSL Behring GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameHaemocomplettan® P
    D.3.4Pharmaceutical form Powder 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 FIBRINOGEN
    D.3.9.1CAS number 9001-32-5
    D.3.9.3Other descriptive nameHUMAN FIBRINOGEN
    D.3.9.4EV Substance CodeSUB12502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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
    congenital fibrinogen deficiency
    deficit congenito di fibrinogeno
    E.1.1.1Medical condition in easily understood language
    deficency of fibrinogen in human plasma
    deficit di fibrinogeno nel plasma umano
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To determine the single dose pharmacokinetics of Octafibrin and Haemocomplettan® P/RiaSTAPTM in subjects with congenital fibrinogen deficiency
    • To determine maximum clot strength (maximum clot firmness [MCF]) as a surrogate marker for haemostatic efficacy before and after
    administration of Octafibrin and Haemocomplettan® P/ RiaSTAPTM in
    subjects with congenital fibrinogen deficiency
     Determinare la farmacocinetica della singola dose di Octafibrin e
    Haemocomplettan ® P / RiaSTAPTM in soggetti con deficit congenito di fibrinogeno
     Determinare la stabilità massima del coagulo (maximum clot firmness [MCF]) come marker surrogato per l'efficacia emostatica prima e dopo la somministrazione di Octafibrin ed Haemocomplettan ® P / RiaSTAPTM in
    soggetti con deficit congenito del fibrinogeno
    E.2.2Secondary objectives of the trial
    To assess the safety of Octafibrin in subjects with congenital fibrinogen deficiency
    Valutare la sicurezza di Octafibrin in soggetti con deficit congenito di fibrinogeno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subject age ≥12 years
    • Documented congenital fibrinogen deficiency (afibrinogenaemia)
    Plasma fibrinogen activity and antigen at screening bellow detection limit (i.e. <20mg/dl)
    • Informed consent signed by subject or legal guardian
     età ≥ 12 anni
     deficit congenito di fibrinogeno documentato (afibrinogenaemia)
    Attività plasmatica del fibrinogeno e antigene allo screening al di sotto del limite di rilevamento (cioè <20mg/dl)
     consenso informato firmato dal soggetto o dal suo rappresentante legale
    E.4Principal exclusion criteria
    • Life expectancy <6 months
    • Bleeding disorder other than congenital fibrinogen deficiency
    • Dysfibrinogenemia
    • Treatment with:
    Any fibrinogen concentrate or other fibrinogen-containing blood product in the 2 weeks prior to enrolment
    • Presence or history of:
    Hypersensitivity to study medication
    ­ Deep vein thrombosis or pulmonary embolism within 1 year prior to enrolment
    ­ Arterial thrombosis within 1 year prior to enrolment
    ­ Hypersensitivity to human plasma proteins
     Acute bleeding
     History of oesophageal varicose bleeding
     End-stage liver disease (i.e. Child-Pugh-score B or C)
     Planned major surgery with a need for blood transfusion during the PK blood-sampling period of this study
     Pregnancy, or an intention to become pregnant during the study
     Currently breast-feeding, or with the intention of breast-feeding during the study
     HIV positive with a viral load >200 particles/μl ~ >400000 copies/ml
     Polytrauma 1 year prior to enrolment
     Suspicion of an anti-fibrinogen inhibitor as indicated by previous in-vivo recovery, if available <0.5 (mg/dl)/(mg/kg), (there is currently no standard test for inhibitors)
     Blood or plasma donation in the 3 months prior to enrolment
     Aspettativa di vita < di sei mesi
     Disturbo della coagulazione differente dal deficit congenito del fibrinogeno
     Disfibrinogenemia
     Terapia con:
    - qualsiasi concentrato di fibrinogeno o altro prodotto ematico
    contenente fibrinogeno nelle due settimane precedenti il reclutamento
     Presenza o storia di:
    - ipersensibilità al farmco in studio
    - trombosi venosa profonda o embolia polmonare entro l'anno
    precedente il reclutamento
    - trombosi arteriosa entro l'anno precedente il reclutamento
    - ipersensibilità alle proteine plasmatiche umane
     emorragia acuta
     storia di emorragia varicosa esofagea
     patologia epatica all'ultimo stadio (con punteggio Child-Pugh B o C)
     Importante intervento chirurgico programmato con necessità di
    trasfusione ematica durante il priodo di campionamento ematico
    farmacocinetico di questo studio
     Gravidanza, o un'intenzione di avviare una gravidanza durante lo studio
     Allattamento, o l'intenzione di avviare l'allattamento durante lo studio
     HIV positivo con carico virale > di 200 particelle/μl ~ >400000
    copies/ml
     Politrauma 1 anno prima del reclutamento
     Sospetto di inibitore anti-fibrinogeno come indicato da precedente ripreso in-vivo, se disponibile <0.5 (mg/dl)/(mg/kg), (non sono
    attualmente disponibili test standard per gli inibitori)
     Donazione di sangue o plasma nei tre mesi precedenti il reclutamento
    E.5 End points
    E.5.1Primary end point(s)
    A comparison of the AUC between Octafibrin and Haemocomplettan®
    P/RiaSTAPTM
    Surrogate endpoint for haemostatic efficacy
    Comparison of MCF between Octafibrin and Haemocomplettan®
    P/RiaSTAPTM at 1 hour post-infusion
    Un confronto dell'AUC tra Octafibrina e Haemocomplettan®
    P/RiaSTAPTM
    Endpoint surrogato per l'efficacia emostatica:
    Confronto della MCF tra Octafibrina ed Haemocomplettan® P/RiaSTAPTM
    a 1 ora dopo l'infusione
    E.5.1.1Timepoint(s) of evaluation of this end point
    at baseline, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 312 hours postinfusion.
    al basale, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 e 312 ore dopo l'infusione
    E.5.2Secondary end point(s)
    • To compare the in vivo recovery between Octafibrin and
    Haemocomplettan® P/ RiaSTAPTM
    • To compare the pharmacokinetics between Octafibrin and
    Haemocomplettan® P/ RiaSTAPTM
    • To document the safety of Octafibrin
     Confrontare il recupero in vivo tra Octafibrina ed Haemocomplettan®
    P/ RiaSTAPTM
     Confrontare la farmacocinetica tra Octafibrina ed Haemocomplettan®
    P/ RiaSTAPTM
     Documentare la sicurezza di Octafibrina
    E.5.2.1Timepoint(s) of evaluation of this end point
    at baseline, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 312 hours postinfusion.
    al basale, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 e 312 ore dopo l'infusione
    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 No
    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) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study Yes
    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) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA15
    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
    Bulgaria
    Germany
    Iran, Islamic Republic of
    Italy
    Spain
    Turkey
    United Kingdom
    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
    LAST PATIENT LAST VISIT
    ULTIMA VISITA DELL'ULTIMO PAZIENTE
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 6
    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: 6
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-04-15. Yes
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 18
    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)
    NONE
    NESSUNO
    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 Decision2013-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-11-28
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