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    Summary
    EudraCT Number:2014-004032-19
    Sponsor's Protocol Code Number:NLOCEAN.505.14
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-09-09
    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 number2014-004032-19
    A.3Full title of the trial
    A randomised, open-label clinical trial assessing the efficacy of octreotide to decrease iron infusion and blood transfusion requirements in patients with refractory anaemia due to gastrointestinal bleeding from angiodysplasias.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effectiveness of the drug octreotide to anemia in patients with small bowel bleeding due to vascualr malformations.
    A.3.2Name or abbreviated title of the trial where available
    OCEAN
    A.4.1Sponsor's protocol code numberNLOCEAN.505.14
    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 SponsorRadboud University Medical Center
    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 supportRadboud University Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud University Medical Center
    B.5.2Functional name of contact pointK.V. Grooteman
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein zuid 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031650235537
    B.5.6E-mailKarina.Grooteman@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 Sandostatin LAR 20 mg
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma B.V.
    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.3.1Product nameSandostatin LAR
    D.3.2Product code RVG 18236
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOCTREOTIDE
    D.3.9.1CAS number 135467-16-2
    D.3.9.2Current sponsor codeSMS995ELAF
    D.3.9.3Other descriptive nameSandostatin LAR
    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 number20
    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
    small bowel angiodysplasias
    E.1.1.1Medical condition in easily understood language
    vascular malformations in the small bowel
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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
    The primary objective of this study is to determine if octreotide significantly decreases the iron infusion or blood transfusion requirement in patients who have refractory anemia due to recurrent gastrointestinal bleeding from small bowel angiodysplasias despite endoscopic intervention.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to investigate whether octreotide prevent the number of rebleeds and thereby increases the haemoglobin level. The third objective is to assess safety of octreotide in a dosage of 40 mg per 4 weeks. With the follow-up data epidemiologic knowledge will be provided.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with refractory anaemia due to gastrointestinal bleeding from small bowel angiodysplasias without any other possible source of bleeding, who are blood transfusion or iron infusion dependent despite endoscopic intervention and oral iron supplementation.
    1. Diagnosis of angiodysplasia is made by upper, lower gastrointestinal endoscopy and video capsule or enteroscopy. Single or multiple 2–5 mm flat bright red spots with round uniform or slightly irregular margins, or lesions appearing as raised and reddened areas with a distinctly irregular margin, when larger than 5 mm are seen.
    2. Transfusion dependent: at least 2 blood transfusions or iron infusions in the 6 months before inclusion, despite an attempt to supplement iron orally.
    3. Failure of endoscopic therapy: at least one attempt with single balloon enteroscopy or dubbel balloon enteroscopy to coagulate the angiodysplasias with APC within the year of diagnosis of symptomatic AD.
    E.4Principal exclusion criteria
    - age < 45 years
    - liver cirrhosis Child-Pugh C, liver failure or diagnosed portal hypertension
    - previous unsuccessful treatment with octreotide for the same indication (refractory anaemia due to angiodysplasias)
    - current thalidomide treatment which is effective (no blood transfusion dependency)
    - patients with chronic renal failure who have a GFR < 30 ml/min
    - severe diseases with life expectancy < 1 year
    - patients with left ventricular assist devices (LVAD’s)
    - Rendu-Osler-Weber
    - pregnancy or nursing women
    - uncontrolled diabetes as defined by HbA1C >64 mmol/ml, despite adequate therapy
    - hereditary hemorrhagic diseases or haematological disorders with active treatment
    - patients with a known hypersensitivity to SST analogues or any component of the sandostatin LAR formulations
    - symptomatic cholecystolithiasis
    - non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study treatment
    - systemic cancer currently undergoing chemotherapy or radiation therapy
    - refusal to enter the study
    - no understanding of Dutch or English
    E.5 End points
    E.5.1Primary end point(s)
    The percentual decrease in blood and iron requirements between the year prior to inclusion and the treatment period of one year. Percentual decrease =
    (number of blood transfusions and iron infusions in the year prior to inclusion -
    number of blood transfusions and iron infusions during the study period ) / number of blood and iron infusions in the year prior to inclusion.
    The percentual decrease will be compared between the intervention and control arm.

    All blood transfusions that are given with another indication than gastrointestinal blood loss are registered, but excluded for analysis for the primary outcome.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After finishing the last follow-up of the last patient (week 60). We will make a comparison between different time intervals in between this period.
    E.5.2Secondary end point(s)
    - Percentage of hemoglobin increase from baseline until end of treatment for patients treated with octreotide compared to the control group
    - The mean difference in hemoglobin level from baseline until end of treatment for patients treated with octreotide compared to the control group
    - Number of patients requiring red blood cell transfusions from baseline until end of treatment for patients treated with octreotide compared to the control group
    - Number of patients requiring other transfusions or medication to correct coagulation between baseline until end of treatment for patients treated with octreotide compared to the control group (see ‘standard of care’)
    - The change in number and severity of bleeding episodes (see for definition section 4.3.2) between start and end of treatment for patients treated with octreotide compared to the control group
    - The change in number of patients free of rebleeding between start and end of treatment for patients treated with octreotide compared to the control group
    - Reduction in oral iron requirement between start and end of treatment for patients treated with octreotide compared to the control group (see for definition section 4.3.3 “standard of care”)
    - The change in level of serum ferritin between baseline until end of treatment for patients treated with octreotide compared to the control group
    - The number and type of adverse events (cardiac, pulmonary, neurological, other) between the control and treatment arm during the treatment period F(1)
    - Difference in number of hospitalizations, ICU admissions and duration of hospitalization between the control and treatment arm during the treatment period F(1)
    - The need for rescue therapy using argon plasma coagulation, coiling or surgery compared between the control and treatment arm during the treatment period F(1)
    - Change in Quality of Life as measured by SF36 and PSQ-An questionnaire between baseline and end of treatment for patients treated with octreotide compared to the control group
    - Mortality and cause of death compared between the control and treatment arm during the treatment period

    E.5.2.1Timepoint(s) of evaluation of this end point
    Saftey endpoints will be analysed after the inclusion of 15 patients or after 6 months after the start of the study. And after the end of the study.
    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 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 concerned15
    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 Yes
    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
    A interim-analysis will be performed on the primary endpoint after a half year. DSMB decides upon the continuation of the trial. The Peto approach is used for beneficial effect. For harm (higher incidence of AEs in the octreotide group) no stopping rule is chosen. In a meeting(s) of both the DSMB and steering committee any increase in AEs in the octreotide arm will be discussed to see whether a causative relation may be present and in light of the international literature.
    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 months2
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state62
    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)
    If patients in the treatment group were responders to octreotide and have a significant decrease of their transusion requirements, they are asked if they want to continue the octreotide. It is there free choice, but the octreotide will be made available through their own insurance company.
    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 Decision2015-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-27
    P. End of Trial
    P.End of Trial StatusCompleted
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