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    Summary
    EudraCT Number:2014-004106-15
    Sponsor's Protocol Code Number:3082B2-3316
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-04-03
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2014-004106-15
    A.3Full title of the trial
    An Evaluation of the Safety and Efficacy of On-Demand Treatment with Xyntha
    (B-Domain Deleted Recombinant Factor VIII, Albumin Free) in Chinese Subjects with Hemophilia A
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects
    A.4.1Sponsor's protocol code number3082B2-3316
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00868530
    A.5.4Other Identifiers
    Name:AliasNumber:B1831015
    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 SponsorWyeth Pharmaceutical Co., Ltd
    B.1.3.4CountryChina
    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 supportWyeth Pharmaceutical Co., Ltd
    B.4.2CountryChina
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointPfizer Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42 Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number18007181021
    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 Xyntha
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Pharmaceuticals, Inc., a subsidiary of Pfizer, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameXyntha
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravascular use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMOROCTOCOG ALFA
    D.3.9.1CAS number 284036-24-4
    D.3.9.2Current sponsor code3082B2
    D.3.9.4EV Substance CodeSUB16445MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMOROCTOCOG ALFA
    D.3.9.1CAS number 284036-24-4
    D.3.9.2Current sponsor code3082B2
    D.3.9.4EV Substance CodeSUB16445MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMOROCTOCOG ALFA
    D.3.9.1CAS number 284036-24-4
    D.3.9.2Current sponsor code3082B2
    D.3.9.4EV Substance CodeSUB16445MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMOROCTOCOG ALFA
    D.3.9.1CAS number 284036-24-4
    D.3.9.2Current sponsor code3082B2
    D.3.9.4EV Substance CodeSUB16445MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    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 No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    Hemophilia A
    E.1.1.1Medical condition in easily understood language
    Disease in which clotting factor VIII (FVIII), is deficient or inactive. Subjects with this condition have an increased risk to bleed compared to unaffected individuals.
    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 17.1
    E.1.2Level LLT
    E.1.2Classification code 10018937
    E.1.2Term Haemophilia A
    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 describe the safety and clinical efficacy of Xyntha in previously treated Chinese subjects with hemophilia A.
    E.2.2Secondary objectives of the trial
    To describe FVIII recovery after exposure to Xyntha in previously treated Chinese subjects with hemophilia A.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia A (FVIII activity: more than 5 percentage (%), 1-5%, or less than 1%, respectively).
    2. Subjects with previous exposure to FVIII replacement therapy.
    3. If human immunodeficiency virus (HIV) positive, documented cluster of differentiation (CD4) count more than 200 per microliter (mcL) within 6 months of study entry.
    E.4Principal exclusion criteria
    1. Diagnosed with any bleeding disorder in addition to hemophilia A.
    2. Current FVIII inhibitor or history of FVIII inhibitor (defined as positive result of the reporting laboratory).
    3. Subject has no history of exposure to FVIII products (previously untreated patient [PUP]).
    4. Subject is currently utilizing primary FVIII prophylaxis.
    5. Subjects anticipating elective surgery that may be planned to occur in the 6 months following study entry.
    6. Treated with immunomodulatory therapy within 30 days prior to study entry or planned use for the duration of their study participation.
    7. Participated in another investigational drug or device study within 30 days prior to study entry or planned participation for the duration of their study participation.
    8. Subjects with a known hypersensitivity to hamster protein.
    9. Significant hepatic or renal impairment (alanine aminotransferase [ALT] and aspartate aminotransferase [AST] >5*upper limit of normal [ULN], bilirubin greater than (>) 2 microgram per deciliter (mg/dL) or serum creatinine >1.25 *ULN).
    10. Prothrombin Time >1.5 * ULN.
    11. Platelet count less than (<) 80,000/mcL.
    12. Pregnant or breastfeeding women.
    13. Unwilling or unable to follow the terms of the protocol.
    14. Any condition which may compromise the subject's ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation, in the opinion of the Investigator or Sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    1) Investigator Hemostatic Efficacy Assessment 8 Hours Post Infusion
    2) Investigator Hemostatic Efficacy Assessment 24 Hours Post Infusion
    3) Number of Participants With Factor VIII (FVIII) Inhibitor Development
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) 8 hours post infusion
    2) 24 hours post infusion
    3) Day 1 and Month 6 or Early Termination Visit
    E.5.2Secondary end point(s)
    1) FVIII Recovery : Change From Baseline in FVIII Concentration
    2) Number of Participants With Less Than Expected Therapeutic Effect (LETE)
    3) Number of Participants With Thrombosis Allergic-Type Reactions
    4) Number of Participants With Thrombosis
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Day 1 and Month 6 or Early Termination Visit
    2) 24 hours after each of 2 successive infusion, up to 6 months
    3) Baseline up to 6 months
    4) Baseline up to 6 months
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    China
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days17
    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: 53
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 6
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 37
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 53
    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
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: China
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