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    Summary
    EudraCT Number:2012-002638-35
    Sponsor's Protocol Code Number:3.00
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-06-11
    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 ConcernedSweden - MPA
    A.2EudraCT number2012-002638-35
    A.3Full title of the trial
    ALBUMIN KINETICS BY 123I-HSA

    A validation study on healthy volunteers, patients with acute inflammation, and patiens scheduled for major abdominal surgery
    ALBUMINKINETIK MED 123I-HSA

    En valideringsstudie på friska frivilliga forsknings-personer, akut inflammerade patienter och kirurgiska patienter som genomgår stor bukkirurgi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Turnover and distribution of the plasma protein albumin, meassured with the radio iodine isotope 123-iodine human serum albumin.

    A validation study in healthy volunteers, patients with acute inflammation, and patiens scheduled for major abdominal surgery
    Omsättning och distribution av det kroppsegna äggviteämnet albumin, mätt med radiojodisotopen 123-jod-mänskligt serumalbumin.

    En utvärderingsstudie på friska frivilliga forsknings-personer, akut inflammerade patienter och kirurgiska patienter som genomgår stor bukkirurgi
    A.3.2Name or abbreviated title of the trial where available
    ALBUMINKINETIK MED 123I-HSA
    A.4.1Sponsor's protocol code number3.00
    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 SponsorStockholms Läns Landsting, Karolinska Universitetssjukhuset Huddinge, Anestesikliniken
    B.1.3.4CountrySweden
    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 supportStockholms Läns Landsting
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska Institutet, Inst CLINTEC
    B.5.2Functional name of contact pointEnheten för Anestesi
    B.5.3 Address:
    B.5.3.1Street AddressAnOpIVA-kliniken B31, Karolinska Univeristetssjukhuset Huddinge
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code141 86
    B.5.3.4CountrySweden
    B.5.6E-mailake.norberg@karolinska.se
    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 Yes
    D.2.1.1.1Trade name SERALB-125
    D.2.1.1.2Name of the Marketing Authorisation holderCIS bio International, R.N. 306- Saclay. B.P.32 91192 GIF-SUR-YVETTE CEDEX FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) Yes
    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 Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Yes
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Natriumjodid (I-123) Mallinckrodt Medical
    D.2.1.1.2Name of the Marketing Authorisation holderMallinckrodt Medical B.V., PO Box 3, 1755 ZG PETTEN, Holland
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    A) healthy volunteers (transcapillary escape rate of albumin, plasmavolume, and turnover of albumin)
    B) Acute inflammation such as pancreatitis or cholecystitis
    C) Scheduled major abdominal surgery such as pancreatico- duodenectomy in pancreatic cancer
    A) Friska frivilliga forskningspersoner (kapillärläckage, plasmavolym och omsättningshastighet för albumin)
    B) Akut inflammation exempelvis pankreatit eller cholecystit
    C) Planerad stor kirurgi exempelvis Whipple´s op av pankreascancer
    E.1.1.1Medical condition in easily understood language
    A) healthy volunteers
    B) Acute inflammation such as pancreatitis or cholecystitis
    C) Scheduled major abdominal surgery such as pancreatico- duodenectomy in pancreatic cancer
    A) Friska frivilliga forskningspersoner
    B) Hastigt påkommen inflammation av exempelvis bukspottkörtel eller gallblåsa
    C) Planerad stor bukkirurgi till exempel operation för cancer i bukspottkörteln
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Do the extempore made tracer 123-iodine labeled albumin an commercially manufactured SERALB-125 give identicla values of calculated blood plasma volume and capillary leakage meassured as transcapillary escape rate of albumin?
    Är mätvärdena för den extempore beredda tracern 123-jodmärkt albumin och kommersiella SERALB-125 identiska avseende beräknad plasmavolym respektive transkapillärt läckage av albumin?
    E.2.2Secondary objectives of the trial
    How do three different meassures of albumin turnover correlatein volunteers?

    How do the pharmacokinetic parameters of endogenous albumin vary between the three study groups?
    Hur starkt korrelerar tre olika mätningar av albumins omsättningshastighet hos voluntärer?

    Hur varierar de olika farmakokinetiska parametrarna för albumin mellan de tre olika studiegrupperna?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A) INCLUSION CRITERIA VOLUNTEERS
    - Healthy volunteers, men and women ≥ 40 years
    - Anticonception for fertile women
    - Good peripheral blood vessels
    - Written informed consent
    B) INCLUSION CRITERIA PATIENTS WITH ACUTE INFLAMMATION
    - Severe inflammation such as acute pankreatitis or acute cholecystitis
    - Men and women ≥ 40 years
    - Written informed consent
    C) INCLUSION CRITERIA ELECTIVE SURGICAL PATIENTS
    - Scheduled major abdominal surgery such as pancreatectomy
    - Men and women ≥ 40 years
    - Written informed consent

    A) INKLUSIONSKRITERIER FORSKNINGSPERSONER
    - Friska frivilliga forskningspersoner, män och kvinnor ≥ 40 år
    - Tillförlitlig antikonception för kvinnor
    - Goda perifera blodkärl
    - Signerat skriftligt samtycke
    B) INKLUSIONSKRITERIER AKUT INFLAMMERADE PATIENTER
    - Kraftig inflammation t ex akut pankreatit eller akut cholecystit
    - Män och kvinnor ≥ 40 år
    - Signerat skriftligt samtycke
    C) INKLUSIONSKRITERIER ELEKTIVA KIRURGISKA PATIENTER
    - Planerad stor kirurgi t ex pankreaskirurgi
    - Män och kvinnor ≥ 40 år
    - Signerat skriftligt samtycke

    E.4Principal exclusion criteria
    EXCLUSION CRITERIA ALL GROUPS (A-C)
    - Pregnancy or nursing
    - Allergy to the investigational medical products
    - Participation in any other study commencing radiation or stable isotopes within 60 days
    - Any circumstance that in the judgement of the investigator makes the participation of the volunteer or patient unsuitable.
    EXKLUSIONSKRITERIER ALLA GRUPPER (A-C)
    - Graviditet eller amning
    - Allergi mot prövningsläkemedlet
    - Deltagande i annan studie med strålning eller stabila isotoper inom 60 dagar
    - Omständighet som gör att ansvarig forskare bedömer patientens eller forskningspersonens deltagande såsom olämpligt
    E.5 End points
    E.5.1Primary end point(s)
    1) Transcapillary escape rate for albumin
    2) Plasma volume
    1) Transkkapillär läckagehastighet av albumin
    2) Plasmavolym
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 and 2) Blood sampling for 90 min from isotope injection
    1 och 2) Blodprovstagning under 90 minuter från isotopinjektion
    E.5.2Secondary end point(s)
    1) Plasma albumin (P-albumin)
    2) Fractional syntesis rate of albumin (FSR)
    3) Fractional catabolic rate for albumin over 24 hours (FCR1, only in volunteers)
    4) Fractional catabolic rate meassured over the whole study period (FCR30, onlyu in volunteers)
    5) Absolute synthesis rate of albumin (ASR)
    1) Plasma-albumin (P-albumin)
    2) Fraktionell synteshastighet för albumin (FSR)
    3) Fraktionell katabol hastighet för albumin över 1 dygn (FCR1, bara hos voluntärer)
    4) Fraktionell katabol hastighet mätt över hela mätperioden (FCR30, bara hos voluntärer)
    5) Absolut synteshastighet för albumin (ASR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Same numbers as above
    1) All blood samples until 42 dagar (volunteers) or 90+90 min (patients)
    2) Blood samples during 90 min after injection of stable isotope
    3) Urine collection for 24 hours (day 6, 13, 20)
    4) Blood samples up to 42 days
    5) Calculated from P-albumin and plasma volume i.e. sampling for 90 min
    Samma nummer som ovan
    1) Alla blodprover upp till 42 dagar (voluntärer) eller 90+90 minuter (patienter)
    2) Blodprover under 90 minuter efter att stabil isotop getts
    3) Urinsamling under 1 dygn (dag 6, 13, 20)
    4) Blodprover under hela studieperioden upp till 42 dagar
    5) Beräknas ur P-albumin och plasmavolym dvs prover under 90 min
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    This is a validation study of a extempore made tracer compared with a commercial.
    Tracer studies have no medcial effects but are used for studying human physiology, in this case pharmacokinetic variables of endogenous albumin distribution and turnover at different levels of inflammation.
    Valideringsstudie av egentillverkad tracer som jämförs med en kommersiell.
    Tracerstudier har inga egna effekter utan det är fysiologi som studeras, i detta fall farmakokinetiska variabler av endogen albumindistribution och omsättning vid olika grader av inflammation.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    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 No
    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 study is completed when we have collected data from 10 evaluable subjects in each study group
    Studien avslutas när vi samlat data från 10 evaluerbara deltagare i varje grupp.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    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
    Ingen
    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 Decision2012-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-11
    P. End of Trial
    P.End of Trial StatusOngoing
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