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    Summary
    EudraCT Number:2021-001806-32
    Sponsor's Protocol Code Number:ARG-01
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-11-03
    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 number2021-001806-32
    A.3Full title of the trial
    Influence of Argipressin on blood loss and inflammatory response during hepatic resection; a double blinded, randomized, placebo-controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of Argipressin on blood loss and inflammation during liver surgery
    Argipressins effekter på blodförlust och inflammatoriskt svar under leverkirurgi
    A.4.1Sponsor's protocol code numberARG-01
    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 SponsorSahlgrenska University Hospital
    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 Västra Götealand
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSahlgrenska Universitetssjukhuset/Sahlgrenska
    B.5.2Functional name of contact pointAnOpIVA
    B.5.3 Address:
    B.5.3.1Street AddressBlå Stråket 5
    B.5.3.2Town/ cityGothenburg
    B.5.3.3Post code413 45
    B.5.3.4CountrySweden
    B.5.4Telephone number+46(0)313428171
    B.5.6E-mailellinor.wisen@vgregion.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 Empressin®
    D.2.1.1.2Name of the Marketing Authorisation holderAOP Orphan Pharmaceuticals AG Färögatan 33, 31 TR 16454 Kista, Sweden, office.se@aoporphan.com
    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 nameArgipressin (vasopressin)
    D.3.4Pharmaceutical form Concentrate for solution 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.3.8INN - Proposed INNArgipressin
    D.3.9.1CAS number 113-79-1
    D.3.9.4EV Substance CodeSUB05561MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.8 U/ml
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hepatic resection due to primary malignant disease, metastasis or benign tumour
    E.1.1.1Medical condition in easily understood language
    Liver surgery due to primary malignant disease, metastasis or benign tumour
    Leveroperation på grund av malign sjukdom
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10019701
    E.1.2Term Hepatic neoplasm malignant resectable
    E.1.2System Organ Class 100000004864
    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 if infusion of Argipressin during hepatic resection surgery reduces blood loss compared to placebo
    E.2.2Secondary objectives of the trial
    •To determine if infusion of Argipressin during hepatic resection surgery reduces the need of transfusions during and after surgery, compared to placebo.
    •To determine if infusion of Argipressin during hepatic resection surgery mitigates the postoperative inflammatory response, compared to placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Participant planned for hepatic resection (open or laparoscopic, regardless of indication for surgery).
    2.Age ≥18 years.
    3.ASA class I-III.
    4.Signed informed consent form
    E.4Principal exclusion criteria
    1.Participant does not understand the given information, and/ or cannot give written informed consent.
    2.Simultaneous operation of tumor with other localization, or surgery for superficial single hepatic tumor less than 2 cm, expected to be of short duration and with minimal blood loss.
    3.Terminal kidney failure (estimated preoperative GFR< 15 ml/min)
    4.Pregnancy or lactation.
    5.Known allergy to Empressin®.
    6.Patient included in other interventional study, interacting with the endpoints in the present study, or previous randomization in this study.
    7.Hyponatremia (S-Na < 130 mmol/L)
    8.Patient considered ineligible for other surgical or medical reason.
    9.Present infection
    Patients with systemic inflammatory disease, inflammatory bowel disease or preoperative corticosteroid treatment will not be eligible for the subgroups (extended testing) where cytokines and interleukins are investigated
    E.5 End points
    E.5.1Primary end point(s)
    Blood loss (ml) at the end of surgery, measured according to the investigator’s instructions, by visual assessment of suction devices and gauze, and subtraction of ascites and irrigation fluids
    E.5.1.1Timepoint(s) of evaluation of this end point
    At completion of surgery
    E.5.2Secondary end point(s)
    •Blood transfusion (ml) at the end of surgery and at postoperative day 1.
    •Levels of WBC, CRP, PLT and Albumin at the end of surgery and postoperative day 1-5.
    •Levels of IL-1beta IL-6, IL-8, IL-10, MCP-1, SDF-1alfa, ICAM, C3a, C5b-9 at the end of surgery and postoperative day 1 and 2.

    To evaluate effects of the study drug on kidneys, heart and intestines, tissue biomarkers will be part of the study protocol:
    •Plasma creatinine will be controlled at postoperative day 1, 2 and 5. Urine NAG, urine creatinine and urine [TIMP-2] x [IGFBP-7] will be controlled after surgery.
    •Hs-TNI will be controlled at the end of surgery and at postoperative day 1.
    •Arterial lactate will be controlled at the end of surgery, at three hours after surgery and at postoperative day 1.
    •IFABP will be controlled at three hours after surgery and postoperative day one.

    Perioperative data and hemodynamic measurements as listed below will be recorded and presented as descriptive data.
    •Vasopressor use during surgery, achievement of CVP goal, total urine output and use of furosemide at postoperative day 1.
    •Measurements of mean arterial blood pressure (MAP), heart rate, CVP and Cardiac Index (if applicable), as well as assessment of capillary refill time in digits at the end of surgery.
    •Total time of surgical hepatic occlusion and radicality of resection.
    •Clinical Frailty Scale (CFS) at inclusion, length of stay in hospital, and postoperative complications documented at postoperative day 30
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of surgery and day 1-5
    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) 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 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 concerned2
    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 end of the study is defined as “the last performed investigation in the last subject”. In the present study this will be when data from the 30 day follow up is collected for the last patient included
    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 months10
    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: 124
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 124
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-11-03. Yes
    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 state248
    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)
    Patients will be followed up by the surgical team according to clinical routine until 30 days after surgery. Usually, this follow-up is made by phone call, and postoperative complications will be registered in the SweLiv registry. Data will be obtained from the registry, and noted in the eCRF
    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 Decision2021-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-27
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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