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    Summary
    EudraCT Number:2009-012703-25
    Sponsor's Protocol Code Number:PHSU02
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-10-19
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-012703-25
    A.3Full title of the trial
    A prospective double-blind, randomised concept study of PXL01 versus placebo in flexor tendon surgery.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to compare study drug versus dummy treatment (placebo) in flexor tendon surgery in which the method for analysing data has been specified in the protocol before the study has begun (prospective),
    the patients have been randomly assigned to receive either the study drug or dummy treatment (placebo), and in which neither the patient nor the physician conducting the study know which treatment is being
    given to the patient.
    A.3.2Name or abbreviated title of the trial where available
    PHSU02
    A.4.1Sponsor's protocol code numberPHSU02
    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 SponsorPergamum AB
    B.1.3.4CountrySweden
    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 supportPergamum AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPergamum AB -Margit Mahlapuu
    B.5.2Functional name of contact pointChief Scientific Officer
    B.5.3 Address:
    B.5.3.1Street AddressBanvaktsvägen 12
    B.5.3.2Town/ citySolna
    B.5.3.3Post code171 48
    B.5.3.4CountrySweden
    B.5.4Telephone number+4631762 29 02
    B.5.6E-mailmargit.mahlapuu@pergamum.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 namePXL01
    D.3.2Product code PXL01
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codePXL01
    D.3.9.3Other descriptive namePXL01 is a peptide sequence derived from human lactoferrin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Yes
    D.3.11.13.1Other medicinal product typePXL01 is a chemically synthesized peptide structurally derived from human lactoferrin.
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate and solvent for solution for injection
    D.8.4Route of administration of the placeboOther use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with flexor tendon injuries in zone I or II
    E.1.1.1Medical condition in easily understood language
    hand tendon injury
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10043248
    E.1.2Term Tendon rupture
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the efficacy of a single local administration of 20 mg/ml PXL01 in sodium hyaluronate in patients with a flexor tendon injury in zone I or II.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate additional efficacy variables and safety, including rupture rate, of a single local administration of 20 mg/ml PXL01 in sodium hyaluronate in patients with a flexor tendon injury in zone I or II. Exploratory analysis of prognostic factors and covariates of Poor Responders will be performed. In addition, the IMP users’ thoughts about product handling and administration will be evaluated.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The following entry criteria apply:
    1. Complete division of flexor digitorium profundus tendon (FDP) in zone I or II, with or without division of the flexor digitorium superficialis (FDS) and possible to rejoin with tendon suture
    2. Open flexor tendon injury sutured within 14 days after trauma
    3. 18-75 years of age
    4. Signed informed consent prior to any study related procedures
    E.4Principal exclusion criteria
    If one or more of the following criteria are fulfilled, the patient should not be included in the study:
    1. Treatment with any investigational product within 4 weeks of study entry
    2. Patients previously included in the study
    3. Thumbs with complete or partial division of flexor pollicis longus (FPL)
    4. Concomitant fracture(s) requiring immobilisation
    5. Injuries with associated soft tissue loss
    6. Severe crush injury
    7. Palmar plate injury requiring immobilisation
    8. Devascularisation/requirement of vascular repair
    9. Joint injuries
    10. Bilateral injuries
    11. Previous flexor tendon surgery in the digit, which is to be treated wih IMP
    12. Reduced motion in the digit, which is to be treated with IMP, or the corresponding digit prior to the injury
    13. Compliance with mobilisation protocol not expected
    14. Alcohol or drug abuse
    15. Severe intercurrent illness, which in the opinion of the Investigator, may put the patient at risk when participating in the study, or affect the patient’s ability to take part in the study
    16. Pregnant or lactating females
    17. Fertile women who do not accept the consistent and correct use of highly effective methods of birth control defined as implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s, sexual abstinence or vasectomised partner during the first two weeks post-surgery. A condom alone is not considered an acceptable method for birth control, not even together with spermicide.
    18. Known allergy to any component of the study product or placebo
    19. Patients suffering from:
    - Diabetes Mellitus patients where significant diabetic complications may delay healing according to the investigator’s judgement
    - Rheumatoid arthritis
    20. Or patients treated with:
    - Systemic steroids within one month
    - Immunosuppressive drugs within three months
    - Daily use of NSAIDs within one week or occasional use within 8 hours
    E.5 End points
    E.5.1Primary end point(s)
    The primary variable is Total Active Motion (TAM) at the proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints (i.e. TAM2) of the affected digit at actively made fist.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after surgery
    E.5.2Secondary end point(s)
    the secondary endpoints are to evaulate the efficacy and safety variables listed below:
    Efficacy:
    TAM2 at all time points except for 12 weeks
    TAM2 graded according to Strickland's original classification system
    TAM2 over time
    TAM3 (based on MCP, PIP, and DIP joints) at all time points
    TAM3 over time
    Total Active Motion in DIP joint (DIPAM)
    Grip strength
    Tip-to-crease distance
    Disabilities of the Arm, Hand, and Shoulder (DASH) QoL
    Sensory evaluation with Semmes-Weinstein monofilaments (only for patients with any complete digital nerve injury)
    Recommendation for tenolysis
    Total Passive Motion (TPM2 and TPM3)
    Poor Responder defined as "Poor" according to Strickland's Original Classification System, PIP+DIP minus extensor loss < 90 degrees, at 12 weeks

    Safety:
    The frequency and severity of AEs
    Vital signs (blood pressure, heart rate, temperature)
    Blood safety (clinical chemistry, haematology)
    Observation of the surgical area
    Rupture rate
    E.5.2.1Timepoint(s) of evaluation of this end point
    These endpoints will be assessed at various timepoints; between week 2 and 12 months post surgery.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 concerned7
    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 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 visit last patient
    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 months6
    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 months6
    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: 40
    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 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 2010-10-19. 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 state69
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 138
    F.4.2.2In the whole clinical trial 138
    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)
    The IMP will only be applied once in connection to the surgical procedure, hence no study product will be provided to the patients after the study period.
    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 Decision2011-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-02-15
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