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    Summary
    EudraCT Number:2015-000963-15
    Sponsor's Protocol Code Number:MATCH0.1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-12-02
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-000963-15
    A.3Full title of the trial
    MAcrophage Therapy for Liver Cirrhosis (MATCH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MATCH
    A.3.2Name or abbreviated title of the trial where available
    MAcrophage Therapy for Liver Cirrhosis (MATCH)
    A.4.1Sponsor's protocol code numberMATCH0.1
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN10368050
    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 of Edinburgh
    B.1.3.4CountryUnited Kingdom
    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 supportMRC
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Edinburgh
    B.5.2Functional name of contact pointProfessor Stuart Forbes
    B.5.3 Address:
    B.5.3.1Street Address5 Little France Drive
    B.5.3.2Town/ cityEdinburgh
    B.5.3.3Post codeEH16 4UU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0131 651 9500
    B.5.6E-mailstuart.forbes@ed.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorNHS Lothian
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameAutologous Macrophage Cell Product
    D.3.2Product code MATCH
    D.3.4Pharmaceutical form Dispersion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.2Concentration typeup to
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Liver Cirrhosis
    E.1.1.1Medical condition in easily understood language
    Liver disease causing scarring of the liver
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10024667
    E.1.2Term Liver cirrhosis
    E.1.2System Organ Class 100000004871
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I (dose escalation study):
    The primary objective of this study is to demonstrate safety and the maximum tolerated dose of autologous monocyte derived macrophages in participants with advanced liver cirrhosis.

    Phase II (repeat dosing study):
    The primary objective of the repeat dosing study is to demonstrate an improvement in the severity of liver disease over 3 months.

    E.2.2Secondary objectives of the trial
    Secondary objectives are to demonstrate improvement in markers of liver fibrosis, improved disease related quality of life, reduced liver related clinical events and improved transplant free survival.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    INCLUSION CRITERIA

    1. 18≥ AGE ≤75 at screening

    2. Aetiology: one or more of:


    • Alcohol Related Liver Disease (ALD)
    No active alcohol misuse ≥6 calendar months prior to screening. Features of chronic liver disease with a compatible history of alcohol excess (>80g/day), in the absence of other causes of chronic liver disease. Participants with other aetiologies of liver disease may drink alcohol within current recommended limits (14 units per week for females and for males)

    • Primary Biliary Cirrhosis (PBC)
    2 out of:
    Cholestatic LFTs
    Positive AMA (>1:40)
    Compatible Histology

    If already receiving Ursodeoxycholic Acid must be established on current dose >3 months prior to enrolment

    • Non-Alcoholic Fatty Liver Disease (NAFLD)

    Either:
    Histological evidence of steatosis in the absence of other liver diseases
    Or:
    Imaging compatible with NAFLD (eg Fatty infiltration of liver) and one or more risk factors (e.g. elevated BMI, T2DM, Hypertriglyceridaemia, Hypertension)
    And:

    The absence of significant alcohol consumption (<20g/day) and no evidence of other causes of chronic liver disease

    • Cryptogenic cirrhosis

    Diagnosis of cirrhosis unattributable to any other cause

    • Haemochromatosis

    Diagnosis made on basis of compatible Biochemistry (Transferrin Sat >60%, Ferritin >400), Genotype (Homozygous C282Y or H63D, Compound Heterozygote) or Histology

    • Alpha-1 anti-trypsin deficiency

    Diagnosis based on compatible genetic, phenotypic or histological testing.

    • Previous Hepatitis C (sustained viral response ie. undetectable HCV RNA 24 weeks after completion of treatment.)


    3. Diagnosis of Cirrhosis – invasive or non-invasive;

    Cirrhosis, defined as one of:

    • Previous liver biopsy confirming histological features of cirrhosis

    • Transient Elastography (Fibroscan) >15 kPa

    • Clinical and radiological features that in the opinion of the investigator correlate with a diagnosis of cirrhosis

    4. 10>/MELD score</17 at screening
    E.4Principal exclusion criteria
    EXCLUSION CRITERIA

    • Refusal or inability to give informed consent to participate in the study

    • Other cause of chronic liver disease / cirrhosis not included in listed aetiologies – this is left to the clinical judgement of the investigator based on previous investigations and trial screening

    • Portal Hypertensive Bleeding; active episode of bleeding requiring hospitalisation in the last 3 months

    • Ascites unless, in the opinion of the investigator, the ascites is minimal and well controlled with no increase to diuretic therapy in last 3 months

    • Encephalopathy; current or requiring hospitalisation for treatment in last 3 months

    • Hepatocellular Carcinoma – uncertain cases to be discussed at local hepatobiliary Multidisciplinary meeting, dysplastic or indeterminate nodules to be excluded, regenerative or other nodules to be included at discretion of MDM

    • Previous diagnosis of Hepatocellular Carcinoma

    • Previous organ Transplant or previous recipient of tissue


    • Listed for Liver Transplantation

    • Any situation that in the Investigators opinion may interfere with optimal study participation such as alcohol or drug abuse, domicile too distant from study site, potential non-compliance or inability to co-operate

    • Presence of clinically relevant acute illness that in the opinion of the investigator might compromise the participant’s safe participation in the study

    • Presence or history of cancer within past 5 years with exception of adequately treated localised skin carcinoma, in situ cervical cancer or solid malignancy surgically excised in total without recurrence for 5 years

    • Pregnancy or Breastfeeding


    • Allergy to steroids

    - Active infection on the mandatory microbiology blood tests
    - Immunosuppressants eg Azathioprine
    - Current enrolment in an interventional study
    E.5 End points
    E.5.1Primary end point(s)
    Phase I (dose escalation study)
    The primary endpoints are the safety and feasibility and to establish the maximum safe dose of infusion of autologous macrophages to cirrhotic participants

    Phase II (repeat dosing study)
    The change in MELD (Model for End Stage Liver Disease) score (delta MELD) at 3 months from the 1st infusion of macrophages
    E.5.1.1Timepoint(s) of evaluation of this end point
    phase I endpoint once all patients in dose escalation have completed all treatment and reached 14 days safety visit. all patients will be monitored for 1 year post infusion
    phase II endpoint 3 months post infusion
    E.5.2Secondary end point(s)
    Secondary endpoints are changes in the ELF (Enhanced Liver Fibrosis) panel, Protein Fingerprint Biomarkers, Fibroscan, Chronic Liver Disease Quality of Life, UKELD (United Kingdom Model for End Stage Liver disease), blood parameters, number of clinical events and transplant free survival
    E.5.2.1Timepoint(s) of evaluation of this end point
    base line to 90 days changes in our secondary endpoint measures, all patients will be monitored for 1 year post infusion
    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 Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    The latter RCT phase is powered to assess efficacy
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Standard care
    E.8.2.4Number of treatment arms in the trial1
    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 concerned5
    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 Yes
    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
    The end of study is defined as the last participant’s last visit.

    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 74
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 74
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state74
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 74
    F.4.2.2In the whole clinical trial 74
    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)
    Routine treatment for liver cirrhosis
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-19
    P. End of Trial
    P.End of Trial StatusOngoing
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