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    Clinical Trial Results:
    A Multicenter, Prospective, Randomized, Open-label, Intra-patient Controlled Study of the Efficacy and Safety of ABH001 for the Treatment of Stalled Chronic Cutaneous Wounds Associated with Generalized Epidermolysis Bullosa

    Summary
    EudraCT number
    2012-001815-21
    Trial protocol
    ES   DE   AT   PT  
    Global end of trial date
    18 Nov 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Sep 2019
    First version publication date
    21 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EB01-ABH001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01749306
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    ABH_EB-001: ABH_EB-001
    Sponsors
    Sponsor organisation name
    Organogenesis (Transferred from Shire to Organogenesis)
    Sponsor organisation address
    85 Dan Road, Canton, United States, MA 02021
    Public contact
    Compliance, Organogenesis (Transferred from Shire to Organogenesis), Compliance@organo.com
    Scientific contact
    Compliance, Organogenesis (Transferred from Shire to Organogenesis), Compliance@organo.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Nov 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Nov 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective is to evaluate the efficacy of ABH001 in initiating healing of selected cutaneous, clinically non-infected ‘stalled’ wounds in Epidermolysis Bullosa (EB) subjects by comparing the maximum percent reduction in wound surface area from Baseline (Week 0) to Week 24 between ABH001-treated wounds and Control-treated wounds in the Intent-to-Treat population.
    Protection of trial subjects
    The study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, the principles of the Declaration of Helsinki, as well as other applicable local ethical and legal requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Dec 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    United States: 7
    Worldwide total number of subjects
    12
    EEA total number of subjects
    5
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    6
    Adolescents (12-17 years)
    4
    Adults (18-64 years)
    2
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Twelve unique subjects were enrolled into the Observation period of the study.

    Period 1
    Period 1 title
    Treatment Period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    ABH001 application plus wound care dressings
    Arm description
    ABH001 applications topically every 4 weeks (±1 week) with protocol-specified dressings until wound healed or up to 44 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    ABH001 application plus wound care dressings
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous patch
    Routes of administration
    Cutaneous use
    Dosage and administration details
    ABH001 application plus wound care dressings

    Arm title
    Control wound treatment
    Arm description
    Control wound care with protocol-specified dressings every 4 weeks (±1 week) up to 20 weeks with optional cross-over to ABH001 for additional 24 weeks
    Arm type
    Control wound treatment

    Investigational medicinal product name
    Control wound treatment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous patch
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Control wound care with protocol-specified dressings every 4 weeks (±1 week) up to 20 weeks with optional cross-over to ABH001 for additional 24 weeks

    Number of subjects in period 1
    ABH001 application plus wound care dressings Control wound treatment
    Started
    12
    12
    Completed
    0
    0
    Not completed
    12
    12
         Not Randomized
    1
    1
         Study Terminated
    1
    1
         Screen Failure
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Period
    Reporting group description
    Treatment Period

    Reporting group values
    Treatment Period Total
    Number of subjects
    12
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    12.8 ± 9.825 -
    Gender categorical
    Units:
        Male
    9 9
        Female
    3 3

    End points

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    End points reporting groups
    Reporting group title
    ABH001 application plus wound care dressings
    Reporting group description
    ABH001 applications topically every 4 weeks (±1 week) with protocol-specified dressings until wound healed or up to 44 weeks

    Reporting group title
    Control wound treatment
    Reporting group description
    Control wound care with protocol-specified dressings every 4 weeks (±1 week) up to 20 weeks with optional cross-over to ABH001 for additional 24 weeks

    Primary: Reduction in wound surface area in ABH001-treated versus control-treated wounds.

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    End point title
    Reduction in wound surface area in ABH001-treated versus control-treated wounds. [1]
    End point description
    End point type
    Primary
    End point timeframe
    24 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Study was terminated (NOT due to safety concerns). The product Dermagraft was sold to Organogenesis (announcement dated 17 Jan 2014: https://www.shire.com/en/newsroom/2014/january/shire-executes-agreement ).
    End point values
    ABH001 application plus wound care dressings Control wound treatment
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Percent
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [2] - Study was terminated (NOT due to safety concerns).
    [3] - Study was terminated (NOT due to safety concerns).
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 48
    Adverse event reporting additional description
    Study was terminated (NOT due to safety concerns). The product Dermagraft was sold to Organogenesis (announcement dated 17 Jan 2014: https://www.shire.com/en/newsroom/2014/january/shire-executes-agreement ).
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    Adverse events which occurred during the study

    Serious adverse events
    Overall Trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Overall Trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 12 (16.67%)
    Injury, poisoning and procedural complications
    Wound pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    General disorders and administration site conditions
    Fever
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jan 2013
    Re-ordering of secondary objectives and secondary efficacy endpoints. Clarification of safety secondary objective and endpoint to include the capture of subject Adverse Events as well as study wound (added) Adverse Events. Clarification of use of topical antimicrobial dressings and treatment and reformatting of pre-treatment bio-burden reduction components. Follow-up telephone contact time window changed. Addition of monthly follow-up phone contacts between Day 7 and Day 11 after each treatment. Added that in the event that a subject early terminates participation prior to Week 48, the subject or legal guardian/caregiver will be given the option to be contacted by the site through regular follow-up phone contacts post study termination. Addition of Study Completer Part A and Study Completer Part B definitions. Addition of pre-configured (on loan from Sponsor) digital image equipment. Clarification that ClinRO and CGIC are the same reported outcome (Clinician Global Impression of Change). The Intent-to-treat population and Per-protocol populations to include only subjects 3 years or older at the time of enrollment. The statistical considerations were updated for the clinical trial. Wound Care and Dressings: Addition that the lot number for each protocol specified wound care dressing dispensed will be captured on the applicable accountability log. Female Subjects: A definition of what constitutes a Female Of Child Bearing Potential (FOCP) has been added. Screening Period (Week -10): Only medications the subject is currently taking at the time of screening and information regarding exclusionary concomitant medications will be captured during the Screening Period. Subject Stopping Rules have been added. Planned Interim Analysis and Data Monitoring Committee: Steps for blinded sample size-re-estimation have been added.
    24 May 2013
    Addition of procedure to report SAE information to Shire Medical Monitor in addition to Shire Pharmacovigilance and Risk Management (PVRM). Screening Period changed to begin at Week -6. Visit numbers altered to adjust to the screening period change beginning at Week -6. Screening visit window of ± 1 week added for Week -2. Clarification of the Central Reviewer role and the process to be followed between Week -6 and Week -2 for selection of wounds to receive bioburden pre-treatment reduction. Age of wound duration increased from 4 to 8 weeks. Wound selection criteria changed. Mepilex Lite foam dressing added to protocol specified dressings. Randomization of selected wound procedures (using an IWRS system) added regarding storage of randomization codes and breaking the study blind procedures. Wording was added to clarify that during the post treatment phone contacts, sites will also inquire about compliance with wound dressing change and bathing restrictions during the first 7-11 days post treatment. Inclusion criteria altered to allow the wound location to extend over the joint area if the joint area is immobilized or splinted. Addition of inclusion in another Shire Sponsored study pending Investigator assessment that participation does not interfere with any treatment aspect of the EB01-ABH001 study. Adverse and Serious Adverse Events Assessment: Wording was added for suspension of the application of ABH001 on an affected subject pending an immediate safety review by the Sponsor or designated service provider. Clarification for monthly follow-up phone contacts after early termination to occur according to weeks (4 weeks = 1 month).

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Study was terminated (NOT due to safety concerns). The product Dermagraft was sold to Organogenesis (announcement dated 17 Jan 2014: https://www.shire.com/en/newsroom/2014/january/shire-executes-agreement ).
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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