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    Summary
    EudraCT Number:2016-003557-15
    Sponsor's Protocol Code Number:HMB-ICU
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-10-25
    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 number2016-003557-15
    A.3Full title of the trial
    A Study to Investigate the Effect of β-Hydroxy-β-Methylbutyrate (HMB) on Skeletal Muscle Wasting in Early Critical Illness.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Investigate the Effect of β-Hydroxy-β-Methylbutyrate (HMB) on Skeletal Muscle Wasting in Early Critical Illness.
    A.3.2Name or abbreviated title of the trial where available
    HMB-ICU
    A.4.1Sponsor's protocol code numberHMB-ICU
    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 SponsorGuy's and St Thomas NHS Foundation Trust
    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 supportHealth Education England
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportNational Institute for Health Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGuy's and St Thomas NHS Foundation Trust
    B.5.2Functional name of contact pointProfessor Nicholas Hart
    B.5.3 Address:
    B.5.3.1Street AddressSt Thomas’ Hospital, Lane Fox Unit, Ground Floor, South Wing. Westminster Bridge Rd,
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 7EH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4402071854775
    B.5.5Fax number+4402071888330
    B.5.6E-mailnicholas.hart@gstt.nhs.uk
    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 nameβ-Hydroxy-β-Methylbutyrate (HMB)
    D.3.4Pharmaceutical form Powder for oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEnteral use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE
    D.3.9.2Current sponsor codeCALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE
    D.3.9.3Other descriptive nameCALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE
    D.3.9.4EV Substance CodeSUB183932
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 No
    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 placeboPowder for oral solution
    D.8.4Route of administration of the placeboEnteral use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Critical illness
    E.1.1.1Medical condition in easily understood language
    Critical illness
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10077264
    E.1.2Term Critical illness
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of HMB on skeletal muscle mass in early critical illness.
    E.2.2Secondary objectives of the trial
    • To determine the effect of HMB on muscle quality, strength, function and quality of life in ICU survivors.
    • To investigate the effect of HMB on inflammation, cell damage and plasma metabolomics profile over the first 10 days of ICU admission
    • To investigate the effects of HMB on muscle necroptosis (e.g. through TNF-receptor activation) using a primary cell culture assay.
    • To establish the feasibility of such an intervention with the view to designing a multicentre randomised controlled trial.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria are
    (i) ≥18 years old
    (ii) Due to receive enteral nutrition via a nasogastric or naso-jejunal tube as part of routine care
    (iii) Receiving mechanical ventilation and likely to continue this for more than 48 hours
    (iv) Likely to remain on the ICU for >7 days
    (v) Likely to survive intensive care admission.
    (vi) Admitted to recruiting ICU <24 hours from hospital admission and referring ICU  7 days from hospital admission
    (vii) Agreement obtained from legal representative
    (viii) Able to comply with protocol and study procedures
    (ix) No known allergy to IMP or any of its excipients
    Participants in other trials can be recruited where protocols are not deemed likely to interfere with endpoints of either study and agreement has been obtained from the respective Chief Investigators.
    Since participants in the trial will be abstaining by virtue of their illness, contraception is not required as an eligibility requirement.
    E.4Principal exclusion criteria
    (i) Pregnancy or breast feeding
    (ii) Active disseminated malignancy (diagnosed)
    (iii) Bilateral lower limb amputees
    (iv) Non-ambulant or acute unilateral lower limb amputees
    (v) Patients with a primary neuromyopathy
    (vi) Patients entered into trials of interventions which would affect muscle mass
    (vii) Patients assessed as requiring sole parenteral nutrition
    (viii) Admission to ICU within the previous 3 months
    (ix) Any reason excluding ultrasound measurement being performed
    (ix) Insufficient understanding of the trial by the legal representative
    (xi) Intolerance to lactose and/or milk protein allergy
    E.5 End points
    E.5.1Primary end point(s)
    Change in rectus femoris cross-sectional area (RFcsa) at day 10 following Intensive Care Unit (ICU) admission
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 10
    E.5.2Secondary end point(s)
    •Change in RFcsa at day 7, 10, ICU discharge, completion of the intervention, hospital discharge and 3 months post-hospital discharge.
    •Change in muscle echogenicity at 7, 10, ICU discharge, completion of the intervention, hospital discharge and 3 months post-hospital discharge.
    •Between and within group difference in strength change at ICU discharge, completion of the intervention, hospital discharge and 3 months post-hospital discharge.
    •Between and within group difference in physical function change at ICU discharge, completion of the intervention, hospital discharge and 3 months post-hospital discharge.
    •Difference in quality of life scores at 3 months post-hospital discharge.
    •Difference in inflammation, cell damage and plasma metabolic profile over the first 10 days of admission.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 7, ICU discharge, hospital discharge and 3 months post-hospital discharge.
    Day 7, ICU discharge, hospital discharge and 3 months post-hospital discharge.
    Days 7, 10, ICU discharge, hospital discharge and 3-month post-hospital discharge.
    ICU discharge, hospital discharge and 3 months post-hospital discharge.
    ICU discharge, hospital discharge and 3 months post-hospital discharge.
    3 months and 1-year post-hospital discharge.
    First 10 days of ICU admission
    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 No
    E.6.5Efficacy No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 the trial will be defined as the point at which the database is locked.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    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: 68
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 68
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Participants will all be deemed as having 'critical illness.' They will lack capacity to give prospective consent for themselves in the initial stages due to the nature of 'critical illness' and the use of drug therapy, such as sedatives.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state68
    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)
    None
    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 Decision2017-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-31
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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