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    Summary
    EudraCT Number:2016-001340-19
    Sponsor's Protocol Code Number:NLROW.1012.15
    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:2016-07-11
    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 number2016-001340-19
    A.3Full title of the trial
    An uncontrolled, pilot-study assessing the efficacy of octreotide LAR to decrease transfusion requirements and endoscopy frequency in patients with Rendu-Osler-Weber and gastrointestinal bleeding
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effectiveness of the drug octreotide LAR to anemia in patients with gastrointestinal bleeding due to Rendu-Osler-Weber disease.
    A.3.2Name or abbreviated title of the trial where available
    ROW
    A.4.1Sponsor's protocol code numberNLROW.1012.15
    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.5.6E-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 and solution for solution 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 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
    Patients with Rendu-Osler-Weber disease (which is also called: Hereditary hemorrhagic telangiectasia)
    E.1.1.1Medical condition in easily understood language
    Patients with Rendu-Osler-Weber disease (which is also called: Hereditary hemorrhagic telangiectasia.
    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 is to assess the efficacy of octreotide LAR in decreasing the need for transfusions and endoscopic intervention in patients ROW with refractory anaemia due to gastrointestinal bleeding telangiectasias.
    E.2.2Secondary objectives of the trial
    • Does octreotide LAR reduce the number of rebleeds and thereby increases the haemoglobin level?
    A bleeding episode is defined as:
     Overt bleeding: melaena or hematochezia
    or
     Occult bleeding: iron deficiency anaemia and a hematocrit of <30% for >6 months
    • The third objective is to assess safety of octreotide LAR in a dosage of 20 mg per 4 weeks in ROW patients.
    • Fourth, does octreotide LAR decrease the epistaxis episodes in ROW patients?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with Rendu-Osler-Weber
    - Symptomatic gastrointestinal bleeds out of telangiectasias
    - Transfusion and / or endoscopy dependent:
    Transfusion: at least 2 blood and/or iron infusions in the 6 months before inclusion.
    Endoscopy: at least one endoscopy with APC after the initial endoscopic treatment after diagnosis in the half year before inclusion or unsuitable for endoscopy.
    E.4Principal exclusion criteria
    - liver cirrhosis Child-Pugh C or acute liver failure
    - previous unsuccessful treatment with somatostatin analogues for the same indication (refractory anaemia due to telangiectasias) or current effective treatment with a somatostatin analogue
    - current successful treatment with thalidomide
    - severe diseases with life expectancy < 1 year
    - patients with left ventricular assist devices (LVAD’s)
    - Symptomatic cholecystolithiasis (without cholecystectomie)
    - pregnancy or nursing women or women who have a pregnancy wish in the studyperiod or who use anticonception inadequate
    - current chemotherapy
    - patients with a known hypersensitivity to SST analogues or any component of the pasireotide LAR formulations
    - systemic cancer currently undergoing chemotherapy or radiation therapy
    - no understanding of Dutch or English
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome is response to treatment defined as:
    - complete: no endoscopic intervention or transfusion requirements
    - partial: a reduction in endoscopic intervention or transfusion requirements
    - non-response: an equal or increase in endoscopy frequency or transfusions
    E.5.1.1Timepoint(s) of evaluation of this end point
    26 weeks
    E.5.2Secondary end point(s)
     The percentual decrease in blood and iron requirements between the 6 months prior to inclusion and the treatment period of 6 months.
     The percentual decrease in the number of endoscopic interventions between the 6 months prior to inclusion and the treatment period of 6 months.
     The mean/median decrease on the epistaxis severity score (ESS) between baseline and the end of treatment visit (ET).
     Percentage of hemoglobin increase from baseline until end of treatment.
     The mean difference in hemoglobin level from baseline until end of treatment.
     The change in number and severity of GI bleeding episodes (see for definition section 4.3.2) the 6 months prior to inclusion and the treatment period of 6 months.
     The percentual decrease in number of patients free of rebleeding between start and end of treatment.
     Reduction in oral iron requirement between start and end of treatment (see for definition section 4.3.3 “standard of care”)
     The number and type of adverse events (cardiac, pulmonary, neurological, other)
     Difference in number of hospitalizations, ICU admissions and duration of hospitalization between the 6 months prior to inclusion and the treatment period of 6 months.
     Change in quality of life using the SF-36 questionnaire between baseline and end of treatment visit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 26
    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 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 trial is when the last patient has had the last study visit, which is the follow-up visit in week 30.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 13
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state15
    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 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 Decision2016-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
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