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    Clinical Trial Results:
    Open, Randomized, Active Comparator-controlled, Multi-Center Study to Evaluate Safety and Efficacy of IBsolvMIR® in Islet Transplantation

    Summary
    EudraCT number
    		 2016-001867-35
    Trial protocol
    		 SE   NO   NL  
    Global end of trial date
    13 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 May 2025
    First version publication date
    23 May 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NNCIT-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03867851
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    TikoMed
    Sponsor organisation address
    Box 81, Viken, Sweden, 26303
    Public contact
    Project Director IBsolvMIR, TikoMed AB, info@tikomed.com
    Scientific contact
    Project Director IBsolvMIR, TikoMed AB, info@tikomed.com
    Sponsor organisation name
    TikoMed
    Sponsor organisation address
    Box 81, Viken, Sweden, 26303
    Public contact
    Henrik Otendal, TikoMed, info@tikomed.com
    Scientific contact
    Henrik Otendal, TikoMed, info@tikomed.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Sep 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Apr 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    13 May 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective is to study safety and tolerability of IBsolvMIR® in comparison to Heparin, in combination with standard immunosuppressive therapy in islet transplantation.
    Protection of trial subjects
    Transplantations performed according to Nordic Network of Clinical Islet Transplantation SOPs. These include close monitoring of the vital signs of the patient, including ultrasound examination of possible bleeding after transplantation. DMC safety meetings were held once the 2 first patients received the IBsolvMIR treatment. Each time the DMC held a safety meeting, the data (safety data from start of IMP/comparator treatment until at least the follow-up on Day 7), needed to be reviewed by the DMC before the next patient could be included. The DMC monitored SAEs on a regular basis. When an SAE occurred, the members of the DMC were notified via e-mail/eCRF alert. The DMC chairman then considered the need for an additional DMC meeting. In case of a suspected unexpected serious adverse reaction (SUSAR) related to IBsolvMIR, the DMC chairman always scheduled an extra meeting before the study could commence.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Feb 2020
    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
    Norway: 1
    Country: Number of subjects enrolled
    Sweden: 6
    Worldwide total number of subjects
    7
    EEA total number of subjects
    7
    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)
    7
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Male and females aged 18 to 65 years diagnosed with T1D (onset of disease at <40 years of age and insulin-dependence for > 5 years at the time of enrolment), and with documented C-peptide <0.1 nmol/L before first islet transplantation, who were on the waiting list to receive an islet transplantation were considered for inclusion in the study.

    Pre-assignment
    Screening details
    		 Standard Nordic network of Clinical Islet transplantation (NNCIT) criteria used. In addition, patients with known bleeding disorders were not included in the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Heparin
    Arm description
    		 Standard of care
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Leo Heparin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    70 U/kg body weight

    Arm title
    		 IBsolvMIR
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    IBsolvMIR
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intravenous use
    Dosage and administration details
    The IBsolvMIR solution was given as a bolus dose (10 min) IV infusion of 18 mg/kg BW the day of transplantation (Day 0) followed by 3 additional doses of 3 mg/kg BW on Day 1, 3 and 6 after transplantation. The IMP was not available outside the clinical study.

    Number of subjects in period 1
    		Heparin IBsolvMIR
    Started
    1
    6
    Completed
    1
    4
    Not completed
    0
    2
         Adverse event, non-fatal
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Heparin
    Reporting group description
    		 Standard of care

    Reporting group title
    IBsolvMIR
    Reporting group description
    		 -

    Reporting group values
    		 Heparin IBsolvMIR Total
    Number of subjects
    		 1 6 7
    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)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
        Adults (18-65 years)
    		 1 6 7
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 41 (41 to 41) 46.5 (32 to 57) -
    Gender categorical
    Units: Subjects
        Female
    		 1 4 5
        Male
    		 0 2 2
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) will consist of all subjects who have been enrolled and received at least one dose of the IMP (IBsolvMIR or Heparin). This population will be used as Safety analysis set.

    Subject analysis sets values
    		 Full analysis set
    Number of subjects
    7
    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)
    7
        From 65-84 years
    0
        85 years and over
    0
        Adults (18-65 years)
    7
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    45.7 (32 to 57)
    Gender categorical
    Units: Subjects
        Female
    5
        Male
    2

    End points

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    End points reporting groups
    Reporting group title
    Heparin
    Reporting group description
    		 Standard of care

    Reporting group title
    IBsolvMIR
    Reporting group description
    		 -

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) will consist of all subjects who have been enrolled and received at least one dose of the IMP (IBsolvMIR or Heparin). This population will be used as Safety analysis set.

    Primary: Signs of bleeding Day 1

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    End point title
    		 Signs of bleeding Day 1 [1]
    End point description
    • Bleeding events after islet transplantation with total dose of 27 mg/kg BW IBsolvMIR in comparison to active comparator heparin
    End point type
    Primary
    End point timeframe
    Day 0 to Day 1
    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: There were too few patients to do any meaningful statistical analyses.
    End point values
    		 Heparin IBsolvMIR Full analysis set
    Number of subjects analysed
    1
    6
    7
    Units: Bleeding events
        number (not applicable)
    0
    1
    1
    No statistical analyses for this end point

    Primary: AEs/SAEs after islet transplantation

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    End point title
    		 AEs/SAEs after islet transplantation [2]
    End point description
    AEs/SAEs after islet transplantation with total dose of 27 mg/kg BW IBsolvMIR in comparison to active comparator heparin. Related to bleeding.
    End point type
    Primary
    End point timeframe
    Day 0 to Day 44
    Notes
    [2] - 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: There were too few patients to do any meaningful statistical analyses.
    End point values
    		 Heparin IBsolvMIR Full analysis set
    Number of subjects analysed
    1
    6
    7
    Units: Events
        number (not applicable)
    0
    14
    14
    No statistical analyses for this end point

    Secondary: Difference between groups in levels of biomarkers after transplantation

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    End point title
    		 Difference between groups in levels of biomarkers after transplantation
    End point description
    The objective was: •To evaluate the effect of IBsolvMIR on transplant-induced coagulation biomarkers (TAT complexes, D-dimer, platelet consumption) in comparison to heparin •To evaluate the effect of IBsolvMIR on transplant induced humoral immunity biomarkers (C3a, soluble complement membrane attack complex [C5b-9]) in comparison to heparin •To evaluate the effect of IBsolvMIR on transplant induced cellular immunity biomarkers (cytokines) in comparison to heparin •To evaluate the effect of IBsolvMIR on engraftment stimulation biomarkers (HGF, vascular endothelial growth factor A [VEGF-A], fibroblast growth factor [FGF]) in comparison to heparin •To evaluate the effect of IBsolvMIR on transplant induced islet destruction biomarkers (C-peptide, soluble tissue factor [TF] and platelet endothelial cell adhesion molecule 1 [PECAM-1]) in comparison to heparin Too few patients to be able to perform any analysis
    End point type
    Secondary
    End point timeframe
    Day 0 to Day 7
    End point values
    		 Heparin IBsolvMIR
    Number of subjects analysed
    1
    6
    Units: Levels
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Change in levels of C-peptide/(glucose x creatinine) ratio

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    End point title
    		 Change in levels of C-peptide/(glucose x creatinine) ratio
    End point description
    Effect of IBsolvMIR on C-peptide/glucose/creatinine ratio at 14 days, compared to baseline and to heparin
    End point type
    Secondary
    End point timeframe
    Day 0 to Day 14
    End point values
    		 Heparin IBsolvMIR
    Number of subjects analysed
    1
    6
    Units: Change in ratio from baseline
        median (full range (min-max))
    0.244 (0.244 to 0.244)
    0.7685 (0.265 to 1.32)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs (including SAEs) were collected from the time point the patient was hospitalised for transplantation until last follow-up visit on Day 14 for AEs and until Day 44 for SAEs.
    Adverse event reporting additional description
    Roughly two thirds of the AEs (23/35 events) occurred in one patient and included 2 SAEs.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.01
    Reporting groups
    Reporting group title
    Heparin
    Reporting group description
    		 Standard of care comparator

    Reporting group title
    IBsolvMIR
    Reporting group description
    		 -

    Serious adverse events
    		 Heparin IBsolvMIR
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    3 / 6 (50.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic haemorrhage
    Additional description: Patient 1: Transplantation and IBsolvMIR at noon Day 0; CT performed 01:17 day after showing bleeding. Patient 2: CT scan showed bleeding Day 3, patient received also the Day 1 IBsolvMIR dose of 3 mg/kg.
         subjects affected / exposed
    0 / 1 (0.00%)
    2 / 6 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Heparin IBsolvMIR
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    5 / 6 (83.33%)
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Blood iron decreased
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Platelet count increased
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Transaminases increased
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Catheter site pain
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Pain
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Haemolysis
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 1 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    1
    2
    Abdominal pain lower
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 1 (100.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Nausea
         subjects affected / exposed
    1 / 1 (100.00%)
    2 / 6 (33.33%)
         occurrences all number
    1
    2
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    0 / 1 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    2
    Metabolism and nutrition disorders
    Fluid overload
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Hypocalcaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Hyponatraemia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         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
    25 Feb 2019
    Reduction in amount of blood sampled (removal of PK and HGF samples on Day 6, and all exploratory samples), changed IMP manufacturer, minor corrections/clarifications.
    19 Dec 2019
    Addition of 1 site in Gothenburg, Sweden (site 3) and clarification of the roles. Change of 1 lab. Specification of local standard of care treatment. Changed timing and condition of portal catheter removal. Changes in sampling time points and addition of biomarkers to be analysed. Changed disposition of the secondary objectives. Time window for screening samples. Minor corrections/clarifications
    24 Aug 2020
    Medical Expert Safety Group/Safety Committee changed all over to data safety monitoring board (DSMB). Changes/clarifications in the following sections: • 7.1 and 7.4: Added background dosing • 7.5: Risk benefit APTT prolongation, high bolus dose with conc. Med. Enoxaparin and aspirin. • 9.1 correction wording study end, clarification on islet transplantation SOPs. • 9.2.2: pregnancy f-up for WOBCP Day 28. • 9.2.3 clarification study drugs precautions. • 9.2.4 Separation first 4 patients, WOCBP definition. • 9.2.5 Treatment stopping rules clarification. • 9.4.1 Heparin treatment duration added. • 9.4.2 Treatment assignment procedure clarified. • 9.5.1.2: Possible repeated pregnancy test at screening of WOCBP added. • 9.5.4 Change determination of AE causality, clarification of SAE, serious adverse drug reaction (SADR), and SUSAR. • 9.5.5, 9.5.6: AE/SAE Evaluation is done for both study drugs, clarification. • 9.5.6 SAE reporting procedure clarified. • 9.5.7 SUSAR section added. • 9.5.8 DSMB procedure specified. • 9.7.1 SAP will be finalised before study start. • Appendix 1 and 2: Clarification heparin administration. • Appendix 4: Removed.
    18 Jul 2022
    • New Manufacturer for drug substance. • New formulation of IMP. • Section 7.2 Changed IMP-specifications and labels. • Section 9.2.2 specified that the number of episodes of severe hypoglycaemia the last 1 year should be recorded.
    06 Oct 2022
    • Section 7.2: IMP labels corrected. Specification of vial and package numbering. • Section: 9.3 Inclusion criterion 6, change in text, not only MMTT to measure C-peptide.
    22 Feb 2023
    • Section 7.2 Information regarding new vial size included. • Section 9.3 Exclusion criterion #1 modified, failed pancreas transplants removed within a week are accepted.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    05 Apr 2022
    As planned according to the DMC charter, inclusion was paused after two patients were treated until the DMC-meeting was held. The DMC concluded there was no emerging safety concerns and recommend that the study proceed according to the current protocol.
    19 Apr 2022
    29 May 2023
    SAE Renal impairment (Seriousness criterion: Prolonged hospitalisation); No ad hoc DMC meeting according to chairman. Rational for the decision: Acute rise in creatinine was secondary to tacrolimus toxicity (levels 16 and 15) compounded by spironolactone exposure. Spironolactone stopped. Creatinine now recovered. Does not seem at all related to study drug. No further action required.
    10 Jun 2023
    03 Nov 2023
    SAE hepatic bleeding; inclusion interruption until DMC meeting. DMC recommendation: The DMC voting members recommend the sponsor to advise the participating centres to implement the method using avitene powder for tract closure if practically possible. The DMC members do not recommend the sponsor to halt the trial if such method is not implemented at all centres but consider the risk of a definitive discontinuation of the trial if another bleeding event occurs within the context of such a small trial.
    23 Nov 2023
    24 Feb 2024
    SAE hepatic bleeding; The DMC conclude that it is difficult to definitively assign the causality of the current event of hepatic bleeding to the trial treatment IBsolvMIR. However, the current event is the second hepatic bleeding in the trial treatment group consisting of in total only six patients. Given the anticoagulating properties of the study treatment, it is likely but not proven that IBSolvMIR contributed to the severity of the event. The DMC can therefore not support a continuation of the trial under the current protocol and recommend the sponsor to discontinue the trial. If the protocol is amended to mitigate the risk of bleeding events, the Sponsor/group of participating investigators are encouraged to seek the opinion of the DMC for the sufficiency of these safety measures. 13 May 2024, the sponsor decided that the protocol would not be amended to mitigate the risk of bleeding and that the causality with study treatment would not be further investigated. The patient enrolment difficulties contributed to the decision.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Since the inter-individual variation was high, the sample size small, and the control group only consisted of a single patient, no firm conclusions can be drawn based on biomarker data.
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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