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    Summary
    EudraCT Number:2010-019888-10
    Sponsor's Protocol Code Number:B1531002
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-09
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2010-019888-10
    A.3Full title of the trial
    PROSPECTIVE OPEN-LABEL INVESTIGATION OF THE NON-SURGICAL TREATMENT WITH COLLAGENASE CLOSTRIDIUM HISTOLYTICUM (XIAPEX®) (X)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective Open-label Investigation of the Non-surgical Treatment with
    collagenase clostridium histolyticum Xiapex® (X)
    A.3.2Name or abbreviated title of the trial where available
    B1531002/Point-X
    A.4.1Sponsor's protocol code numberB1531002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01229436
    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 SponsorPfizer Inc., 235 East 42nd Street, New York, NY 10017
    B.1.3.4CountryUnited States
    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 supportPfizer Inc
    B.4.2CountryUnited States
    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 pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number001303739 1119
    B.5.6E-mailClinicalTrials.govCallCentrere@pfizer.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameXiapex®
    D.3.2Product code PF-05076985
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUSAN: collagenase clostridium histolyticum
    D.3.9.1CAS number 955049-04-0
    D.3.9.2Current sponsor codePF-05076985
    D.3.9.3Other descriptive nameXiapex
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    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 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
    Dupuytren’s contracture
    E.1.1.1Medical condition in easily understood language
    Dupuytren's contracture
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10013873
    E.1.2Term Dupuytren's contracture operation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this study are to evaluate the safety and efficacy of
    Xiapex® in subjects with Dupuytren's contracture, the recovery and
    associated use of Health Care in patients in Europe when physicians and
    subjects are given the opportunity to treat the affected hand (or hands)
    by selecting which cord and joint to treat with each injection
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility should be reviewed and documented by an
    appropriately qualified member of the investigator's study team before
    subjects are included in the study. Subjects must meet all of the
    following criteria to enter the study:
    1. At least 18 years of age and ≤ 70 years.
    2. Presenting with a Dupuytren's contracture of at least 20 degrees
    caused by a palpable cord in at least one finger other than the thumb.
    3. Positive "table top test" defined as the inability to simultaneously
    place the affected finger(s) and palm flat against a table top.
    4. In good health, based upon the results of a medical history, physical
    examination, and safety laboratory profile.
    5. Female subjects of child bearing potential must use a highly effective
    contraception method or be surgically sterilized or be a post menopausal female (ie, no menses for at least 1 year). A pregnancy test will be performed prior to enrollment in the study.
    6. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    7. Subjects who are willing and able to comply with scheduled visits,treatment plan, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the
    study:
    1. Nursing or pregnant, or plan to become pregnant during the treatment phase.
    2. On an investigational drug within 30 days prior to the first dose of
    study drug.
    3. Received a treatment on the selected joint, within 90 days of
    enrollment in the study, for Dupuytren's contracture including needle
    aponeurotomy or any surgical procedure.
    4. Patients with a known systemic hypersensitivity to collagenase or any
    of the other product excipients.
    5. On anticoagulant medication or has received anticoagulant medication
    (except aspirin less than 150 mg daily) within 7 days before the first
    injection.
    6. Has any clinically significant medical history or condition(s), including
    conditions that affect the hands, that would, in the opinion of the
    investigator, substantially increase the risk associated with the subject's
    participation in the protocol or compromise the scientific objectives of
    the study.
    7. Has a chronic muscular, neurological, or neuromuscular disorder that
    affects the hands.
    8. Other severe acute or chronic medical or psychiatric condition or
    laboratory abnormality that may increase the risk associated with study
    participation or investigational product administration or may interfere
    with the interpretation of study results and, in the judgment of the
    investigator, would make the subject inappropriate for entry into this
    study.
    9. Has jewelry on the hand to be treated that cannot be removed.
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    • AEs, vital signs, clinical laboratory parameters and ADAs.
    Efficacy:
    • TPED and PED (Total Passive Extension Deficit: a sum of the Passive
    Extension Deficits (PED) in the MP, PIP, and DIP joints).
    • Change in TPED and PED for each joint treated.
    • ROM.
    • Patient and physician global assessment of treatment satisfaction and
    disease severity.
    Recovery, Hand functionality and HCRU:
    • Type and amount of concomitant pain medications.
    • Total recovery time, time to use the hand, daily activities, work vs.
    hobbies.
    • Hand functionality – Unité Rhumatologique des Affections de la Main
    (URAM) scale will be completed only for subjects in France, the United
    Kingdom, Germany, Sweden and Hungary.
    • Healthcare resource utilization questionnaire.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days post injection
    E.5.2Secondary end point(s)
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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 Yes
    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 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 EEA45
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    as per protocol
    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 months7
    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 months7
    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 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 250
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-31
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