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    Summary
    EudraCT Number:2017-003687-12
    Sponsor's Protocol Code Number:RAV1.2
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-09-22
    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 number2017-003687-12
    A.3Full title of the trial
    Infusion rate and volumekinetics for hyperoncotic albumin in healthy subjects (RAV),
    - A phase IV, randomized, open-labeled, cross-over study
    Infusionshastighetens påverkan på volymskinetik för 20% albumin hos friska försökspersoner.
    - En fas IV, randomiserad open-label, cross-over studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect off infusion rate of hyperoncotic albumin and koncentration off albumin on fluid balance in the body
    Hur mycket betyder dropphastigheten av 20% albumin för vätskestatus i kroppen?
    Vad har koncentrationen av albumin för betydelse?
    A.3.2Name or abbreviated title of the trial where available
    RAV
    A.4.1Sponsor's protocol code numberRAV1.2
    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 SponsorRegion Ostergotland
    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 supportRegion Ostergotland
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegion Ostergotland
    B.5.2Functional name of contact pointBurn Unit
    B.5.3 Address:
    B.5.3.1Street AddressUniversity Hospital
    B.5.3.2Town/ cityLinköping
    B.5.3.3Post code581 85
    B.5.3.4CountrySweden
    B.5.4Telephone number+46101031154
    B.5.6E-mailjoachim.zdolsek@regionostergotland.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 Albunorm 200 g/l
    D.2.1.1.2Name of the Marketing Authorisation holderOctapharma AB
    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.3.1Product nameHuman albumin
    D.3.4Pharmaceutical form Solution for infusion
    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 No
    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 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.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 Albunorm 50 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderOctapharma AB
    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.3.1Product nameHuman albumin
    D.3.4Pharmaceutical form Solution for infusion
    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 No
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthy adult volunteers
    Fluid mobilisation.
    Friska försökspersoner.
    Vätskemobilisering.
    E.1.1.1Medical condition in easily understood language
    Healthy individuals.
    To investigate if oedema fluid can be mobilised from the tissues to the blood and excreted as urine.
    This is of interest for patients with oedema.
    Friska försökspersoner
    Undersökning med målsättning om grad av vätskemobilisering från vävnad till blod och utsöndring som urin.
    Detta är av intresse för patienter med ödem.
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    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
    To study if infusion rate of intravenous administered hyperoncotic albumin is relavant for attraction of fluid from the interstitium and to compare this effect with isooncotic albumin.
    Har infusionshastigheten av hyperonkotiskt albumin betydelse för hur stort vätskeflödet från interstitiet till blodbanan blir?
    Hur stor blir skillnaden om man använder isoocotiskt albumin?
    E.2.2Secondary objectives of the trial
    Does the infusion rate of hyperoncotic albumin effect the duration of the hyperoncotic induced plasma dilution?
    Is there a difference when comparing with an equivivalent dose isooncotic albumin?
    Påverkar infusionshastigheten av hyperonkotiskt albumin durationen av den hyperonkotiskt inducerade plasma expansionen?
    Finns det några skillnader vid jämförelse med motsvarande mängd albumin givet som isoonkotisk lösning?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy volunteers
    Friska försökspersoner
    E.4Principal exclusion criteria
    1. > 60 år
    2. Anamsticaly known decreased kidney function
    3. Hypotensive problems, such as a feeling of dizzyness when rizing up to quickly.
    4. Hypertension (systolic blood pressure >150 and diastolic blood pressure > 95)
    5. Allergic reaction to albumin infusion.
    6. Taking part in a clinicak trial within 30 Days previously.
    7. Pregnancy, which is tested with Urin-hcg.
    8. Dementia or problems to understand instructions.

    1. Fyllda 60 år
    2. Genom anamnes känd njurfunktionspåverkan
    3. Hypotensiva besvär (tex svimningskänsla i samband med att personen reser sig hastigt)
    4. Hypertension (systoliskt blodtryck >150 och diastoliskt blodtryck > 95)
    5. Tidigare allergisk reaktion på albumin tillförsel.
    6. Deltagande i annan läkemedelstudie mindre än 30 dagar tidigare
    7. Graviditet, då fysiologin snabbt kan ändras mellan mättillfällena (Graviditetstest på kvinnor Urin-hcg före varje studietillfälle).
    8. Demens, eller svårigheter att förstå instruktioner.

    E.5 End points
    E.5.1Primary end point(s)
    Difference in fluid recruitment from the tissues depending on infusion rate of hyperoncotic albumine (a combination on blood volume expansion and urinary output).
    Skillnad i vätskerekryterande effekt från vävnaden beroende på infusionshastighet (kombinationen av volymsexpansion och diures)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Six hours after start of infusion. The effects of the infusion rates are compared after the end of the study.
    Sex timmar efter påbörjad infusion. Effekten av de olika infusionerna jämförs efter avslutad praktisk del av studien.
    E.5.2Secondary end point(s)
    1. What is the maximum blood volume expansion with the two different infusion rates?
    2. Bloodvolume expansion over time?
    3. From where is the fluid recruited?
    4. Albumine leakage depending on infusion rate.
    5. What happens with the glycocalyx of the endothelium depending on infusion rate ?
    6. Is there a difference compared to isooncotic solution
    1. Hur stor maximal blodvolymsexpansion ger de olika infusionshastigheterna
    2. Hur ser volymsexpansionen ut över tid
    3. Vad är fördelningen av den rekryterade vätskan. Från interstitiet respektive från det intracellulära rummet.
    4. Albumin-läckage beroende på infusionshastighet.
    5. Hur påverkar albumin-infusionerna endotelets glycocalyx samt frisättning av ANP?
    6. Finns det en skillnad gentemot en infusion isoonkotiskt albumin
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study 6 hours after start of infusion.
    6 timmar efter infusionsstart.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Albumin 50 mg/ml en isoonkotisk lösning av albumin
    Albumin 50 mg/ml an isooncotic solution of albumin
    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 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 trial will end when the last volunteer has had the last follow up visit/phone-call, 3 to 7 days after the last albumin infusion.
    Studien avslutas i sin helhet i samband med det sista uppföljande samtalet/telefonsamtalet 3-7 dagar efter den sista albumin infusionen, till den tolfte och sista försökspersonen genomförts.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    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: 12
    F.1.3Elderly (>=65 years) No
    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 No
    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 state12
    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)
    Healthy volunteers are given something to eat and drink. Thereafter they are free to leve the hospital. They are also provided with a phone number in case of a delayed unexpected event and in case of additional questions.
    If any of the participants has less than 20 ml/h urinary output an additional acetated Ringers will be infused to avoid possible hyperoncocity.
    3 to 7 days after each infusion every subject will be contacted and asked about any inconvenience.
    Friska försökspersoner får något att äta och dricka. Sedan kan de lämna sjukhuset. De får även ett tel nr för eventualiteten av oväntad försenad reaktion samt om ytterligare frågor skulle uppstå.
    Om någon av försökspersonerna har en diures som understiger 20 ml/h så får de en infusion med Ringeracetat, för att undvika eventuell hyperonkocitet. 3 till 7 dagar efter varje infusionstillfälle kontaktas varje försöksperson angående om de upplevt något obehag.
    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 Decision2017-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-01-31
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    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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