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    Summary
    EudraCT Number:2020-004075-41
    Sponsor's Protocol Code Number:2020-6941
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-21
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-004075-41
    A.3Full title of the trial
    Effectiveness of Somatostatin Analogues in patients with Gastric antral vascular ectasia and symptomatic gastrointestinal bleeding: SAGAVE-Pilot study
    Effectiviteit van somatostatine-analogen bij patiënten met Gastric antral vascular ectasia en symptomatische gastro-intestinale bloeding: SAGAVE-pilotstudie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research on the effectiveness of octreotide in Gastric Antral Vascular Ectasia (GAVE)
    in patients with anemia.
    Onderzoek naar de effectiviteit van octreotide in Gastric Antral Vascular Ectasia (GAVE)
    bij patiënten met bloedarmoede.
    A.3.2Name or abbreviated title of the trial where available
    SAGAVE-Pilot study
    A.4.1Sponsor's protocol code number2020-6941
    A.5.4Other Identifiers
    Name:NL8824Number:NTR
    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 SponsorRadboudumc
    B.1.3.4CountryNetherlands
    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 supportRadboudumc
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboudumc
    B.5.2Functional name of contact pointAfdeling MDL
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein Zuid 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310243611111
    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 Sandostatin LAR
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameSandostatin LAR
    D.3.4Pharmaceutical form Emulsion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular 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 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 Yes
    D.3.11.13.1Other medicinal product typeSomatostatin analogue
    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
    Gastric Antral Vascular Ectasia (also known as watermelon stomach)
    Gastric Antral Vascular Ectasia (ook wel bekend als watermeloenmaag)
    E.1.1.1Medical condition in easily understood language
    Gastric Antral Vascular Ectasia (also known as watermelon stomach)
    Gastric Antral Vascular Ectasia (ook wel bekend als watermeloenmaag)
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    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 investigate the efficacy and safety of octreotide treatment (a somatostatin analogue) in decreasing the transfusion requirements (IV iron infusions and / or red blood cell transfusions) in patients with GI bleeding caused by GAVE, who are refractory to endoscopic therapy.
    De werkzaamheid en veiligheid van behandeling met octreotide (een somatostatine-analoog) te onderzoeken op het verlagen van de transfusiebehoefte (IV ijzerinfusies en / of rode bloedceltransfusies) bij patiënten met gastro-intestinale bloeding veroorzaakt door GAVE, die ongevoelig zijn voor endoscopische therapie.
    E.2.2Secondary objectives of the trial
    To investigate the efficacy of octreotide in: decreasing the endoscopic treatment frequency, increasing the health-related quality of life and decreasing the level of fatigue.
    De werkzaamheid van octreotide onderzoeken op: het verlagen van de endoscopische behandelfrequentie, het verhogen van de gezondheidsgerelateerde kwaliteit van leven en het verminderen van de mate van vermoeidheid.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    - Patients older than 18 years with written informed consent.
    - Endoscopic diagnosis of GAVE, confirmed within the last 12 months
    - Endoscopic refractory: at least 1 endoscopic APC, RFA, or other treatment modality performed within 12 months OR unable to receive endoscopic treatment (e.g. Pacemaker, ICD) OR patient has repeatedly indicated that they do not want endoscopic treatment OR treating physician had deemed further endoscopic treatment not relevant
    - Substantial transfusion dependency: at least 4 blood units and / or intravenous iron in the 6 months prior to study inclusion with:
    ◼ At least one serum ferritin below < 30 ug/l within the last 6 months requiring iron infusion above or equal to 1 g and/or
    ◼ Haemoglobin below 5.6 mmol/l (9.0 g/dl) or are in need of transfusions due to anaemia related symptoms within the last 6 months requiring red blood cell transfusion above.
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    - Insulinoma
    - Uncontrolled diabetes mellitus as defined by HbA1c >64 mmol/ml, despite adequate therapy,
    - Symptomatic cholecystolithiasis (possible side effect octreotide),
    - Pregnancy or nursing women or women have a pregnancy wish during the study period.
    - Liver cirrhosis Child-Pugh C
    - Chronic or acute pancreatitis
    - Patients with other plausible causes of gastrointestinal bleeding (e.g. severe portal hypertensive gastropathy and oesophageal varices which have recently bled)
    - Bradycardia (heart rate below 50)*
    - Hypersensitivity to the active ingredient (octreotide) or to auxiliary materials of the study medication
    - Severe diseases / comorbidities with a life expectancy < 1 year
    - Use of other anti-angiogenic drug treatment (thalidomide and / or bevacizumab)

    *If a patient has a heart rate below 60 and uses cardiovascular medication that affect the heart rate (e.g. beta blockers and calcium channel blockers) the prescribing specialist (or another competent specialist) will be consulted about the possibility to adjust the dose of these medicines. Patients with a heartrate below 50 (despite dose adjustments) will be excluded from participation.

    The endoscopic appearance of diffuse-pattern GAVE can be similar to portal hypertensive gastropathy (PHG). An important difference is that PHG only occurs in patients with portal hypertension. A patient with portal hypertension and no clear endoscopic distinction between both disorders cannot be included, unless a biopsy has been taken to confirm the diagnosis.
    E.5 End points
    E.5.1Primary end point(s)
    ‘Successful response’, defined as a decrease of ≥50% in the number of intravenous iron infusions and / or the number of red blood cell transfusions given between baseline period (26 weeks prior to study inclusion) and during the treatment study period (26 weeks).

    NB Patients who exclusively or primarily used IV iron infusions at baseline and required (more) red blood cell transfusions during the treatment study period will be counted as treatment failures regardless of their percentual decrease in IV iron infusions. Patients who exclusively or primarily used red blood cell transfusions at baseline and required (more) iron infusions during the treatment study period will be counted as treatment failures if their total number of red blood cell transfusions and iron infusions during the treatment study period exceeds half of the total number of red blood cell transfusions (and iron infusions) during baseline.

    NB The exact preparation and dosage of IV iron infusions should be noted for each infusion. The preparation of IV iron should be kept consistent at baseline and during study period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    o weeks (study visit 1)
    4 weeks (study visit 1)
    12 weeks (study visit 2)
    26 weeks (study visit 3)
    30 weeks (follow-up visit)
    E.5.2Secondary end point(s)
    The absolute mean and/ median difference and the percentage mean and median difference between the half year prior to inclusion baseline (26 weeks prior to study inclusion) and the treatment study period (26 weeks) of patients in the treatment arm compared to patients in the observational arm between the treatment and observational arm in:
    - Number of red blood cell transfusions
    - Number of Intravenous iron infusions requirements (per 500mg)
    - Number of endoscopic treatments

    The absolute mean and/ median difference and the percentage mean and median difference at baseline (< 7 days before inclusion) between and after 4 weeks, 12 weeks, and 26 weeks of the study period after a half year between patients in the treatment arm and patients in the observational arm in the value of:
    - Hemoglobin and ferritin levels

    The absolute mean and/ median difference and the percentage or mean and median difference between baseline (26 weeks prior to study inclusion) and the treatment study period (26 weeks) the value at baseline and after a half year between of patients in the treatment arm compared to patients in the and observational arm in:
    - Patient reported outcome measures (PROMS): which include quality of life (measured by the SF-36) and level of fatigue (measured by the multidimensional fatigue inventory (MFI)-20)

    The absolute or mean and/ median difference and the percentage mean and median difference after a half year in the number of (S)AE’s during the treatment study period (26 weeks) between patients in the treatment arm and patients in the observational arm.

    The absolute mean and median difference and the percentual mean and median difference between baseline (26 weeks prior to study inclusion) and the treatment study period (26 weeks) of patients in the treatment arm compared to patients in the observational arm in cost effectiveness. Cost effectiveness will be defined by measuring the healthcare costs. The following volumes of healthcare will be registering in Case Record Forms (CRF): (co) medication, visits and consultations to specialists or other health care professionals, lab and imagine techniques, operations, general practitioners and hospitalizations. The volumes of healthcare will be multiplied with the respective (Dutch) cost prices to get the healthcare costs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    o weeks (study visit 1)
    4 weeks (study visit 1)
    12 weeks (study visit 2)
    26 weeks (study visit 3)
    30 weeks (follow-up visit)
    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 No
    E.8.1.1Randomised No
    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 No
    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 concerned3
    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 will be ended prematurely in case of the following:
    1. An official instance (e.g. an ethics commission) does not allow continuation of the trial
    2. The sponsor wishes to end the study
    3. The cost-benefit analysis does not promote continuation of the study.
    4. The expected benefit of the trial does not justify the risks
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 2
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 12
    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 may continue treatment if deemed beneficial to the patient.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Netherlands Trial Register
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-19
    P. End of Trial
    P.End of Trial StatusOngoing
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