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    Summary
    EudraCT Number:2018-004179-11
    Sponsor's Protocol Code Number:2018-4898
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-11-26
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-004179-11
    A.3Full title of the trial
    Effectiveness of Somatostatin Analogues in Patients with hereditary hemorrhagic telangiectasia and symptomatic gastrointestinal bleeding, the SAIPAN-trial: a multicenter, randomized, open-label, parallelgroup, superiority trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effectiveness of Octreotide in hereditary hemorrhagic telangiectasia (a.k.a. Rendu-Osler-Weber disease) patients who suffer from gastrointestinal bleeding.
    Efficacité des analogues de la somatostatine chez les patients atteints de la maladie de Rendu-Osler et présentant des saignements gastro-intestinaux symptomatiques.
    A.3.2Name or abbreviated title of the trial where available
    SAIPAN-trial
    A.4.1Sponsor's protocol code number2018-4898
    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 supportZonMw
    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 pointE.J.M. van Geenen
    B.5.3 Address:
    B.5.3.1Street AddressPostbus 9101
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6500HB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310248187313
    B.5.6E-mailerwin.vangeenen@radboudumc.nl
    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 Octreotide
    D.2.1.1.2Name of the Marketing Authorisation holderSeveral companies
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOCTREOTIDE
    D.3.9.1CAS number 83150-76-9
    D.3.9.4EV Substance CodeSUB09417MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hereditary hemorrhagic telangiectasia (HHT)
    E.1.1.1Medical condition in easily understood language
    Osler–Weber–Rendu syndrome
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effectiveness of somatostatin analogues in decreasing the transfusion requirements in patients with HHT and GI bleeding who are refractory to endoscopic therapy.
    E.2.2Secondary objectives of the trial
    Investigate the effectiveness of octreotide on: decreasing the endoscopic
    treatment frequency, increasing the quality of life, decreasing fatigue and epistaxis symptoms and costeffectiveness.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients older than 18 years with written informed consent.
    -Diagnosis of HHT: either confirmed by genetic testing or the Curaçao criteria (definite diagnosis) (7).
    -Presence of endoscopic proven GI AVM manifestations / telangiectasias confirmed within the last 12 months (upper and/or lower endoscopy and/or capsule endoscopy).
    -Endoscopic refractory: at least 1 endoscopic APC, laser, or other endoscopic treatment modality performed in the past 5 years.
    -Diagnosis of iron deficiency anemia (IDA). IDA is defined as:
    o 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
    o Hemoglobin below 5.6 mmol/l (9.0 g/dl) or are in need of transfusions due to anemia related symptoms within the last 6 months and
    o The absence of other common causes of anemia (Vitamin B12 and/or folate deficiency in patients with macrocytic anemia and bone marrow disorders in patients with pancytopenia)
    -Substantial transfusion dependency: at least 4 blood units and / or intravenous iron in the 6 months prior to study inclusion.
    E.4Principal exclusion criteria
    -Liver cirrhosis Child-Pugh C,
    - Insulinoma,
    - Uncontrolled diabetes mellitus as defined by HbA1c >64 mmol/ml, despite adequate therapy,
    - Juvenile Polyposis Syndrome
    - Symptomatic cholecystolithiasis (possible side-effect octreotide)
    -Chronic or acute pancreatitis
    -Bradycardia (heart rate below 50)*
    -Hypersensitivity to the active ingredient (octreotide) or to auxiliary materials of the study medication
    -Severe disease/comorbidities with a life expectancy < 1 year
    -Use of chemotherapy and / or ciclosporin
    -Pregnancy or nursing women or women who have a pregnancy wish during the study period.
    -Women of childbearing potential who do not have a confirmed menstrual period and a negative, highly sensitive urine or serum pregnancy test < 7 days before inclusion
    -Women of childbearing potential who do not use a highly effective contraceptive measure (according to section 4.1 of the Recommendations related to contraception and pregnancy testing in clinical trials of the Heads of Medicines Agencies (HMA)) or refuse to maintain this measure during the entire treatment- and relevant systemic exposure period.(25)
    -Women of childbearing potential who refuse to undergo additional pregnancy testing during the treatment period
    -Use of other anti-angiogenic drug treatment (thalidomide and/or bevacizumab)
    -Use of hormonal (estrogen) therapy and/or antifibrinolytic therapy (tranexamic acid) to treat anemia due to telangiectasia with sufficient effect. However, when patients are red blood cell transfusion or iron infusion dependent despite these treatment options and are naïve to octreotide treatment, patients are still eligible for inclusion.
    E.5 End points
    E.5.1Primary end point(s)
    'successful response', defined as a decrease of ≥50% in the amount of
    units intravenous iron and/or blood transfusions given
    E.5.1.1Timepoint(s) of evaluation of this end point
    26 weeks prior to study inclusion and during the treatment study period
    (26 weeks).
    E.5.2Secondary end point(s)
    The percentual or mean/median difference between the half year prior
    to inclusion and the treatment period of a half year between the treatment and
    observational arm in:
    - blood and intravenous iron requirements
    - PROM´s: quality of life (SF-36, EQ-5D), level of fatigue (multidimensional fatigue inventory (MFI)-20), epistaxis severity (ESS tool), and patient satisfaction
    - hemoglobin and ferritin levels
    - number of endoscopic treatments
    - cost-effectiveness (see economic evaluation)
    - Safety: All adverse events occurring during the study will be recorded in the patient's medical records.
    E.5.2.1Timepoint(s) of evaluation of this end point
    26 weeks prior to study inclusion and during the treatment study period (26 weeks).
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard of care
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA6
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 is ended when all patients have had their last trial visit.
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 38
    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 have follow-up according to regular care.
    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 Decision2021-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-20
    P. End of Trial
    P.End of Trial StatusOngoing
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