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    Summary
    EudraCT Number:2012-000516-28
    Sponsor's Protocol Code Number:39032
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-05-22
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-000516-28
    A.3Full title of the trial
    A prospective clinical study on the efficacy of collagenase clostridium histolyticum (CCH) injections in the thumb and first web space contractures in Dupuytren's Disease
    Een prospectief klinisch onderzoek naar de werkzaamheid van collagenase clostridium histolyticum (CCH) in de duim en eerste web contracturen bij de ziekte van Dupuytren
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The efficacy of CCH in the thumb and first webspace in Dupuytren's Disease
    De effectiviteit van CCH bij de ziekte van Dupuytren in de duim en eerste webcontractuur
    A.3.2Name or abbreviated title of the trial where available
    The efficacy of CCH in the thumb and first webspace in Dupuytren's Disease
    De effectiviteit van CCH bij de ziekte van Dupuytren in de duim en eerste webcontractuur
    A.4.1Sponsor's protocol code number39032
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00003300
    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 SponsorUniversity Medical Centre Groningen
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer Ltd
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Centre Groningen
    B.5.2Functional name of contact pointDept of Plastic Surgery
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9700RB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031503618840
    B.5.5Fax number0031503613043
    B.5.6E-mailp.m.n.werker@umcg.nl
    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 Xiapex
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 01/12/9001
    D.3.9.3Other descriptive nameCOLLAGENASE
    D.3.9.4EV Substance CodeSUB13443MIG
    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 Disease
    De ziekte van Dupuytren
    E.1.1.1Medical condition in easily understood language
    Dupuytren's Disease causing contractures of fingers and thumb
    De ziekte van Dupuytren veroorzaakt contracturen aan vingers en duim
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effectiveness of CCH as treatment for Dupuytren's contracture in the thumb and first web space by assessing pre and post treatment extension deficit and adduction contractures
    Het beoordelen van de effectiviteit van CCH als behandeling voor de ziekte van Dupuytren in de duim en eerste webspace door pre en post behandeling de extensiebeperking en adductie contractuur te meten en te vergelijken
    E.2.2Secondary objectives of the trial
    No
    nee
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At least 18 years of age and ≤ 75 years.
    • Presenting with a Dupuytren’s contracture at MCPJ of thumb of at least 20° caused by a palpable cord, or any adduction contracture of the thumb with palpable cords in first web space.
    • In good health, based upon the results of a medical history and physical examination.
    • Female patients of child bearing potential must use an acceptable method of birth control or be surgically sterilized or be a post menopausal female (i.e. no menses for at least 1 year). A pregnancy test will be performed prior to enrolment in the study in fertile women.
    • Patients who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
    • Minstens 18 jaar en ≤ 75 jaar
    • een Dupuytren’s contractuur in de MCPgewricht van de duim van minstens 20° veroorzaakt door een palpabele streng of een adductie contractuur van de duim met palpabele streng in het eerste web
    • In goede gezondheid, gebaseerd op de resultaten van de medische geschiedenis en lichamelijk onderzoek.
    • Vrouwelijke patienten in de vruchtbare leeftijd moeten een acceptabele anticonceptie gebruiken of gesteriliseerd zijn of post menopausaal (geen menstruatie sinds minstens 1 jaar). Bij vruchtbare vrouwen zal een zwangerschapstest uitgevoerd worden voor inclusie in de studie • Patienten die bereid en voor wie het mogeljik is om mee te doen met de afgesproken bezoeken, het behandelplan en andere studie procedures
    E.4Principal exclusion criteria
    Nursing or pregnant, or planning to become pregnant during the treatment phase.
    • On an investigational drug within 30 days prior to the first dose of CCH.
    • Received a treatment on the selected joint, within 90 days of enrolment in the study, for Dupuytren’s contracture including needle aponeurotomy or any surgical procedure.
    • Patients with a known systemic hypersensitivity to collagenase or any of the other product excipients.
    • On anticoagulant medication or has received anticoagulant medication (except aspirin less than 150mg daily) within 7 days before the first injection.
    • 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.
    • Has a chronic muscular, neurological or neuromuscular disorder that affects the hands.
    • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and in the judgement of the investigator, would make the subject inappropriate for entry into this study.
    • Has jewellery on the hand to be treated that cannot be removed.
    Borstvoeding gevend of zwanger of van plan om zwanger te worden gedurende de behandelfase.
    • Een onderzoeks medicijn gebruikt binnen 30 dagen, voorafgaand aan de eerste dosis van de CCH.
    • Heeft behandeling gehad van het geselecteerde gewricht binnen 90 dagen voorafgaand aan de studie voor de ziekte van Dupuytren, zoals een naald fasciotomie of een andere chirurgische procedure.
    • Bekend met een systemische hypersensitiviteit voor collagenase of een van de andere product onderdelen.
    • Gebruikt anticoagulants, of heeft anticoagulante medicijnen gebruikt binnen 7 dagen voor de eerste injectie (behalve aspirine minder dan 150mg per dag).
    • Heeft een klinisch medische geschiedenis of aandoening (inclusief problemen aan de handen) die volgens de onderzoeker een verhoogd risico kan betekenen als de patient meedoet aan het onderzoek of de wetenschappelijke resultaten van de studie comprommiteren • Heeft een chronische musculaire, neurologische of neuro-musculaire aandoening die ook de handen aantast.
    • Andere ernstige acute of chronische medische of psychiatrische aandoening of een afwijking aangetoond met lab testen, die het risico met betrekking tot deelname aan de studie vergroten of die van invloed kunnen zijn op de interpretatie van de studie resultaten waardoor de proefpersoon naar de mening van de onderzoeker niet geschikt is voor inclusie in de studie .
    • Heeft sieraden aan de te behandelen hand die niet verwijderd kunnen worden
    E.5 End points
    E.5.1Primary end point(s)
    Reduction in extension deficit to 0 - 5 degrees 30 days after last injection
    Reductie in extensie beperking tot 0-5 graden 30 dagen na de laatste injectie
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after last injection
    30 dagen na de laatste injectie
    E.5.2Secondary end point(s)
    1. Goniometry and pollexography will be used to measure baseline and 1, 7, 30 and 90 days and 6 months after last injection for mean change in range of motion from baseline - degrees
    2. Change in “Patient and physician global assessment of treatment satisfaction” from baseline and 7, 30 and 90 days and 6 months after injection, whereby investigator and patient will complete a brief set of questions
    3. Change in outcome of PRWHE DLV (Patient rated wrist/hand evaluation Dutch language version ) from baseline and 7, 30 and 90 days and 6 months after injection whereby the patient will fill in the questionnaire
    4. Photographs will be taken of the diseased hand, during screening and at 30 and 90 days and 6 months.
    1. Goniometrie en polluxografie wordten gebruikt om de baseline te meten en daarna op de dag van behandeling en 7, 30 en 90 dagen en 6 maanden na de laatste injectie om de gemiddelde verandering in range of motion in graden te vergelijken met de baseline
    2. Verandering in “Patient and physician global assessment of treatment satisfaction” van baseline en 7, 30 en 90 dagen en 6 maanden na de injectie waarbij onderzoeker en patient een paar vragen zullen beantwoorden
    3. Verandering in uitkomts van de PRWHE DLV (Patient rated wrist/hand evaluation Dutch language version) van baseline en 7, 30 en 90 dagen en 6 maanden na injectie waarbji de patient een questionnaire invult
    4. Foto's worden gemaakt van de aangedane hand, gedurende het screenings bezoek en 30, 90 dagen en 6 maanden na de injectie.
    E.5.2.1Timepoint(s) of evaluation of this end point
    7,30,90 days and 6 months after injection
    7,30,90 dagen en 6 maanden na injectie
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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.8.5The trial involves multiple Member States No
    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 No
    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 subject, last visit
    laatste subject, laatste bezoek
    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
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state15
    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)
    Not applicable
    Niet van toepassing
    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 Decision2012-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-14
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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