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    Clinical Trial Results:
    Core decompression versus core decompression followed by infusion of Iloprost in the treatment of non-traumatic avascular necrosis of the femoral head

    Summary
    EudraCT number
    		 2020-000624-20
    Trial protocol
    		 DE  
    Global end of trial date
    02 Oct 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jan 2025
    First version publication date
    03 Jan 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ILONA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 DRKS-ID: DRKS00022404
    Sponsors
    Sponsor organisation name
    Universität Leipzig
    Sponsor organisation address
    Ritterstr. 26, Leipzig, Germany,
    Public contact
    ZKS Leipzig, Universität Leipzig, 49 341 97 16247, ilona@zks.uni-leipzig.de
    Scientific contact
    ZKS Leipzig, Universität Leipzig, 49 341 97 16247, ilona@zks.uni-leipzig.de
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Nov 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Oct 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Oct 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Primary objective of the ILONA trial is to show that in patients with non-traumatic avascular necrosis of the femoral head treatment with Iloprost for 10 days in addition to core decompression is more effective compared to core decompression alone with regard to functional outcome assessed by the Harris Hip Score (HHS) after 12 months.
    Protection of trial subjects
    In the first 2-3 days of treatment, the individually tolerated dose must be determined. Blood pressure and heart rate checks are required at the beginning of the infusion and at each dose change (before or at start of new dosage).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 5
    Worldwide total number of subjects
    5
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    5
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study aimed to include a total of 38 patients providing evaluable data on primary and secondary endpoints. During the study period, 17 patients were screened, of which 5 patients were randomized. The first patient was registered for the study on 27.04.2022 and the last patient visit took place on 09.10.2024.

    Pre-assignment
    Screening details
    		 Patients with N-ANFH were pre-screened: After the informed consent, MRI and X-ray images were evaluated by a core lab. If the patient was eligible acc. to the images, further screening took place.

    Pre-assignment period milestones
    Number of subjects started
    		 5
    Number of subjects completed
    		 5

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    The trial is a double-blind trial. Iloprost was provided by the Sponsor to the trial site pharmacies, placebo was provided by the trial site pharmacies. Blinding was performed by the trial site pharmacy at the time of reconstitution. Blinding was performed following a randomisation list provided by the ZKS Leipzig and the pharmacy staff was instructed on how to perform blinding.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Iloprost
    Arm description
    		 patients receiving Iloprost infusion after core decompression
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iloprost
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Iloprost5 should be administered in a dose of max. 20 μg/day for 10 days. In the first 2-3 days of treatment, the individually tolerated dose must be determined. The initial treatment should be started with an infusion rate of 0,5 ng/kg/min for half an hour. The dose should then be increased to 0,625 ng/kg/min and to a maximum of 0,75 ng/kg/min. The exact infusion rate, which is calculated based on body weight, should be set to 0,5, 0,625 or 0,75 ng/kg/ml. If side effects such as headaches and nausea or undesirable drop in blood pressure occur, the infusion rate should be reduced until the dose tolerated by the patient has been determined. In case of serious side effects, the infusion should be interrupted. With the tolerated dose determined in the first 2-3 days, treatment should then generally be continued.

    Arm title
    		 Placebo
    Arm description
    		 patients receiving saline solution infusion after core decompression
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline Solution (Placebo)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    The placebo is saline solution (0,9%) and the procedures for dosage and administration are identical with iloprost, since the trial is blinded.

    Number of subjects in period 1
    		Iloprost Placebo
    Started
    2
    3
    Baseline and Surgery
    2
    3
    Hospital Stay
    2
    2
    Follow-up (V1-V4)
    2
    2
    Completed
    2
    2
    Not completed
    0
    1
         patient cancelled hospital stay (family reasons)
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Iloprost
    Reporting group description
    		 patients receiving Iloprost infusion after core decompression

    Reporting group title
    Placebo
    Reporting group description
    		 patients receiving saline solution infusion after core decompression

    Reporting group values
    		 Iloprost Placebo Total
    Number of subjects
    		 2 3 5
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 2 3 5
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Mean
    Units: years
        arithmetic mean (full range (min-max))
    		 43.5 (37 to 50) 37.3 (28 to 50) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1 2
        Male
    		 1 2 3
    ARCO Score
    Units: Subjects
        ARCO I
    		 0 1 1
        ARCO II
    		 2 2 4
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients analysed according to the randomisation result.

    Subject analysis sets values
    		 Full analysis set
    Number of subjects
    5
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    5
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Mean
    Units: years
        arithmetic mean (full range (min-max))
    39.8 (28 to 50)
    Gender categorical
    Units: Subjects
        Female
    2
        Male
    3
    ARCO Score
    Units: Subjects
        ARCO I
    1
        ARCO II
    4

    End points

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    End points reporting groups
    Reporting group title
    Iloprost
    Reporting group description
    		 patients receiving Iloprost infusion after core decompression

    Reporting group title
    Placebo
    Reporting group description
    		 patients receiving saline solution infusion after core decompression

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients analysed according to the randomisation result.

    Primary: Harris Hip Score

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    End point title
    		 Harris Hip Score
    End point description
    End point type
    Primary
    End point timeframe
    After 12 months (after Core Decompression surgery)
    End point values
    		 Iloprost Placebo Full analysis set
    Number of subjects analysed
    2
    2 [1]
    4
    Units: Score points
        HHS <70 (poor result)
    0
    1
    1
        HHS 70-80 (fair)
    0
    1
    1
        HHS 81-90 (good)
    0
    0
    0
        HHS 91-100 (excellent)
    2
    0
    2
    Notes
    [1] - one patient dropped out before the documentation of the primary endpoint
    Statistical analysis title
    		 reporting of single values
    Statistical analysis description
    Due to the small amount of patients that were recruited, the results are only reported in a descriptive manner.
    Comparison groups
    Iloprost v Placebo v Full analysis set
    Number of subjects included in analysis
    8
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 < 0.05 [3]
    Method
    		 no tests applicable
    Parameter type
    		 no parameter applicable
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard deviation
    Dispersion value
    0
    Notes
    [2] - Due to the small amount of patients that were recruited, the results are only reported in a descriptive manner.
    [3] - The planned tests were not applicable du to the small number of recruited patients.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were documented on special AE-forms from start of the core decompression surgery until 4 weeks after the last application of Iloprost/placebo.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Iloprost
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Iloprost Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Iloprost Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
    2 / 3 (66.67%)
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Pregnancy, puerperium and perinatal conditions
    Abortion early
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Colitis ulcerative
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Feb 2022
    documentation of sociodemographic factors added at baseline, evaluation of outcome scores at V1 deleted, since these are evaluated at V2.
    06 Jun 2023
    trial indication was expanded from "idiopathic non-traumatic avascular necrosis of the femoral head" to "non-traumatic avascular necrosis of the femoral head". Pathogenesis does not play a determining role in the therapy and outcomes considered in the trila. Thus, the trial indication was no longer restricted to idiopathic pathogenesis and this indication extension was also indicated in the trial title. Restrictions regarding the treated side of the hip (more vs. less effected) were changed. The maximum age for eligible patients was changed from 50 to 65 with the note to rule out the differential diagnosis of rapidly destructive osteoarthritis in patients above 50 years of age. Exclusion criterium "known aetiologies" was changed.

    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.
    The trial only recruited 5 instead of 38 patients. Therefore, the recruitment was terminated early and the results are only reported in a descriptive manner.
    For support, Contact us.
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