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    Summary
    EudraCT Number:2009-015086-31
    Sponsor's Protocol Code Number:Ten03
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-02-27
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2009-015086-31
    A.3Full title of the trial
    Ten03: A Phase III Open, Multicentre Study to Investigate the Safety and Efficacy of BPL’s High Purity Factor X in the treatment of the Factor X Deficient Subjects Undergoing Surgery
    Estudio de fase III, multicéntrico y abierto para investigar la seguridad y la eficacia del FACTOR X de alta pureza de BPL para el tratamiento de pacientes con deficiencia de factor X que se someten a cirugía.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study for people with coagulation factor X deficiency, to assess the effectiveness and safety of a high purity factor X concentrate for people having surgery.
    Un estudio para pacientes con deficiencia de factor X, para evaluar la eficiencia y seguridad del factor X de alta pureza en patientes candidatos a cirugia
    A.4.1Sponsor's protocol code numberTen03
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01086852
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/57/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBio Products Laboratory Limited
    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 supportBio Products Laboratory Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBio Products Laboratory Limited
    B.5.2Functional name of contact pointMiranda Norton
    B.5.3 Address:
    B.5.3.1Street AddressDagger Lane
    B.5.3.2Town/ cityElstree, Herts
    B.5.3.3Post codeWD6 3BX
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number440208957 2661
    B.5.5Fax number440208957 2611
    B.5.6E-mailmiranda.norton@bpl.co.uk
    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/3/07/471
    D.3 Description of the IMP
    D.3.1Product nameHuman factor X
    D.3.2Product code FACTOR X
    D.3.4Pharmaceutical form Powder for concentrate for solution for injection/infusion
    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.3.9.1CAS number 9001-29-0
    D.3.9.3Other descriptive nameFACTOR X
    D.3.9.4EV Substance CodeSUB13816MIG
    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.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
    Factor X Deficiency
    E.1.1.1Medical condition in easily understood language
    Factor X deficiency is lack of human coagulation factor X, one of the proteins in blood which enables blood to clot. This deficiency can cause patients to bleed spontaneously or following trauma.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    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
    The primary efficacy variable is the presence or absence of excessive blood loss during surgery.
    E.2.2Secondary objectives of the trial
    A subjective overall assessment by the investigator of FACTOR X in the control of bleeding due to surgery throughout the whole study.
    The incidence of bleeding episodes during treatment with FACTOR X while the subject is at risk of postoperative bleeding, including location and duration.
    Assessment of incremental recovery of FX:C and FX:Ag after the pre-surgery bolus infusion.
    Assessment of FX:C and FX:Ag levels on each day post-surgery.
    Assessment of the cumulative weight-adjusted doses of FACTOR X as measured by FX:C (IU/kg body weight) administered to each subject to
    maintain haemostasis.
    Assessment of the cumulative doses of FACTOR X as measured by FX:C (IU) administered to each subject to maintain haemostasis.
    Amount of weight-adjusted FACTOR X as measured by FX:C (IU/kg body weight) administered daily (day of surgery and each postoperative day) to maintain haemostasis.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Se estudiaran los genotipos de los pacientes participante en el estudio
    Estudio genotipico
    E.3Principal inclusion criteria
    Subjects who are at least 12 years of age at date of written informed consent/assent.
    Subjects who have given written informed consent or, for subjects aged 12-17 years (inclusive), have given written assent and whose parent/guardian has
    given written informed consent.
    Subjects with hereditary mild to severe factor X deficiency (<20% basal FX activity), including previously untreated subjects OR those currently treated with Fresh Frozen Plasma (FFP), Prothrombin Complex Concentrate (PCC) or factor IX/X concentrate by prophylaxis or on demand.
    Subjects who are to undergo surgery in which the investigator believes a factor X concentrate will be required due to a prior history of unusual bleeding, either spontaneously, or after surgery or trauma, in the absence of treatment with a factor X-containing product.
    Female subjects of child-bearing potential with the exception of those entering the study for obstetric delivery must have a negative result on a human chorionic gonadotropin-based pregnancy test. If a female subject is or becomes sexually active, she must practice contraception by using a method of proven reliability for example oral contraceptives in combination with a barrier method, or IUDs (not copper IUDs) for the duration of the study, or for 8 days after the last dose of FACTOR X, whichever is longer.
    E.4Principal exclusion criteria
    Subjects who are required or expected to take other factor X-containing medications during or after surgery.
    Subjects with a history of inhibitor development to FX or a detectable inhibitor to FX (≥0.6 BU) on the Nijmegen-Bethesda assay at screening. Obtaining a
    FX inhibitor result at screening is not mandatory if the subject is to undergo emergency surgery and the local laboratory is unable to perform the analyses prior to the surgical procedure.
    Subjects with thrombocytopenia (platelets < 50 x 109/L).
    Subjects who have clinically significant renal disease (creatinine >200μmol/L).
    Subjects who have clinically significant liver disease (ALT levels greater than three times the upper limit of normal).
    Subjects known to have other coagulopathy or thrombophilia.
    Subjects who are currently participating or have participated in another trial within the last 30 days, with the exception of the BPL Factor X PK study
    (protocol number Ten01).
    Female subjects who are breastfeeding. Subjects participating in the study for obstetric delivery must be informed that they may not breastfeed during the study.
    Subjects who have known or suspected hypersensitivity to the investigational medicinal product or its excipients.
    Subjects known to have abused chemicals or drugs within the past 12 months.
    Subjects with a history of unreliability or noncooperation.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the presence or absence of excessive blood loss during surgery; this is based upon the regulatory advice received during the
    preparation of this protocol. This assessment will be made by the investigator at the subject’s End-of-Treatment Assessment (after the last dose of FACTOR
    X).
    E.5.1.1Timepoint(s) of evaluation of this end point
    During or after surgery
    E.5.2Secondary end point(s)
    - A clinical assessment by the investigator of blood loss due to surgery, compared to subjects without a bleeding disorder.
    - Assessment of the requirement for blood transfusion (units of packed red blood cells or units of whole blood required) during and after surgery, or infusion of autologous red cells.
    - Measurements of haemoglobin pre-operatively, within 2 hours post-operatively, and at discharge.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pre-operative, during and following surgery
    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 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Germany
    India
    Spain
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Per Section 13 of protocol
    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: 2
    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: 2
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 Yes
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4
    F.4.2.2In the whole clinical trial 10
    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)
    See Protocol Section 6.7
    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 Decision2012-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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