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    Summary
    EudraCT Number:2016-001673-32
    Sponsor's Protocol Code Number:P150915
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-10-20
    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 number2016-001673-32
    A.3Full title of the trial
    PREVENTION OF POSTOPERATIVE PANCREATIC FISTULA BY SOMATOSTATIN (PREFIPS)
    PREVENTION DES FISTULES PANCREATIQUES PAR LA SOMATOSTATINE (PREFIPS)

    A.3.2Name or abbreviated title of the trial where available
    PREFIPS
    A.4.1Sponsor's protocol code numberP150915
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCD Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailiratxe.ciriza@aphp.fr
    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 Somatostatine
    D.2.1.1.2Name of the Marketing Authorisation holderEumedica S.A
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameSomatostatine
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    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 INNAcétate de somatostatine hydraté
    D.3.9.1CAS number 51110-01-1
    D.3.9.2Current sponsor codeP150915
    D.3.9.3Other descriptive nameSomatostatine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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.IMP: 2
    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 Siroctid
    D.2.1.1.2Name of the Marketing Authorisation holderCHEMI S.p.A
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameSiroctid
    D.3.2Product code Octréotide
    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 INNAcétate d’octréotide
    D.3.9.2Current sponsor codeP150915
    D.3.9.3Other descriptive nameSiroctid
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 candidate for pancreatic surgery (pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy).
    Patients candidat à une chirurgie pancréatique (DPC ou pancréatectomie gauche avec ou sans splénectomie)
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10049192
    E.1.2Term Pancreatic fistula
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the grade B or C postoperative pancreatic fistula as defined by the ISGPF (International Study Group on Pancreatic Fistula) classification between patients who receive perioperative somatostatin and octreotide
    Comparer le taux de fistule grade B ou C défini par la classification de l'ISGPF (International Study Group on Pancreatic Fistula) entre les patients recevant de la somatostatine et ceux recevant de l'octréotide
    E.2.2Secondary objectives of the trial
    To compare the following endpoints between patients who receive perioperative somatostatin and octreotide:

    1. 60-day >grade 3 pancreatic complication rates (fistula, leak, and abscess) as defined by the MSKCC surgical secondary events system
    2. 90-day overall pancreatic fistula rate (grade A,B and C)
    3. 90-day overall complication rate (grade 1 to 5), severe complication rate (grade 3 to 5) and mortality (grade 5)
    4. Overall duration of drainage required in patients who develop pancreatic complications (date pancreatic complication identified - date drain removed)
    5. Overall length of stay and readmission rate
    6. Cost effectiveness
    Comparer entre les patients recevant de la somatostatine et ceux recevant de l'octréotide:

    1. Le taux de complication pancréatique >grade 3 (fistule et abcès) défini selon la classification du MSKCC surgical secondary events system
    2. Le taux de fistule pancréatique global (grade A, B et C) à 90 jours.
    3. Le taux de complication globale (grade 1 à 5), de complication sévère (grade 3 à 5) et de décès (garde 5) à 90 jours
    4. La durée totale de drainage chez les patients développant une fistule pancréatique.
    5. La durée totale de séjour et le taux de réadmission.
    6. Le rapport cout/efficacité
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    o Men or women aged 18 years or greater
    o Signed informed consent
    o Candidate for pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy
    o Homme ou femme de 18 ans ou plus
    o Ayant signé un consentement informé
    o Candidat à duodénopancréatectomie céphalique ou de pancréatectomie gauche avec ou sans splénectomie
    E.4Principal exclusion criteria
    o Patient with neoadjuvant chemo and/or radiation therapy
    o Pregnancy
    o Breastfeeding
    o Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
    o Patients with abnormal coagulation (INR>1.5) or patients receiving anticoagulants that affect PT (prothrombin time) or APTT (activated thromboplastin time)
    o Patients with WBC <3 X 109/L; PLT <100 X 109/L
    o Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the Investigator
    o Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to inclusion
    o Known hypersensitivity to somatostatin or somatostatin analogues or any component of the somatostatin or octreotide LAR or s.c. formulations
    o Patient previously treated with somatostatin or somatostatin analogues or any component of the somatostatin or octreotide LAR or s.c. formulations
    o Patients treated by ciclosporine
    o Patient without health insurance or social security
    o Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study
    o Patient candidat à un traitement néoadjuvant par chimio ou radiothérapie
    o Grossesse
    o Allaitement
    o Patients avec une pathologie hépatique (cirrhose, hépatite chronique active ou persistante)
    o Patients avec des anomalies de la coagulation (INR>1.5) or recevant un traitement anticoagulant affectant le TP (temps de prothrombine)
    o Patients avec des globules blancs <3 X 109/L et/ou des plaquettes <100 X 109/L
    o Patients ayant une pathologie active ou un antécédent qui pourrait interférer avec l'étude en cours ou l'interprétation des ses résultats selon l'investigateur
    o Patients ayant participé à un essai clinique testant une molécule dans le mois précédant l'inclusion
    o Hypersensibilité connue à la somatostatine ou ses analogues ou tout composant entrant dans la composition de la somatostatine et de l'octréotide
    o Patient précédemment traité par la somatostatine ou ses analogues
    o Patient ne bénéficiant pas de la sécurité sociale
    o Patients ayant des antécédents de non-compliance aux traitements médicaux ou qui ne pourrait pas compléter la totalité de l'étude
    o Patients traités par cyclosporine
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients presenting 90-day > grade B or C postoperative pancreatic fistula as defined by the ISGPF classification between patients who receive perioperative somatostatin and octreotide.
    Secondary Assessment Criteria:
    1. Percentage of 60-day ?grade 3 pancreatic complication rates (fistula, leak, and abscess) as defined by the MSKCC surgical secondary events system
    2. Percentage of 90-day overall pancreatic fistula rate (grade A,B and C)
    3. Percentage of 90-day overall complication rate (grade 1 to 5), severe complication rate (grade 3 to 5) and mortality (Grade 5) according to Dindo-Clavien classification
    4. Overall duration of drainage required in patients who develop pancreatic complications (date pancreatic complication identified - date drain removed)
    5. Overall length of stay and 90-days readmission rate
    6. Incremental resource utilization and cost effectiveness of perioperative somatostatin compared to octreotide to reduce the rate of postoperative fistula, assessed by 90 days evaluation of Total cost, incremental cost effectiveness ratio.
    Pourcentage de patients présentant grade B ou C fistule pancréatique postopératoire (tel que défini par la classification ISGPF) entre les patients qui reçoivent la somatostatine ou l'octréotide.

    Critères d'évaluation secondaire:
    1. Pourcentage de patients avec des complications pancréatiques >grade 3 (fistule et abcès) défini selon la classification du MSKCC.
    2. Pourcentage de taux de fistule pancréatique globale de 90 jours (grade A, B et C).
    3. Pourcentage de taux de 90 jours ensemble complication (grade 1 à 5), le taux de complication sévère (grade 3 to 5) et de mortalité (Grade 5) selon la classification Dindo-Clavien .
    4. Durée totale de drainage nécessaire chez les patients qui développent des complications pancréatiques (date complication du pancréas identifiée- la date de vidange enlevé).
    5. Longueur totale du séjour et 90 jours taux de réadmission
    6. Calcul de la rentabilité de l'utilisation des ressources et de la somatostatine périopératoire par rapport à l'octreotide pour réduire le taux de fistule postopératoire, évaluée par l'évaluation de 90 jours du coût total, incrémentielle rapport coût-efficacité.
    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 No
    E.6.5Efficacy No
    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 No
    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 concerned10
    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
    LVLS
    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 months4
    E.8.9.1In the Member State concerned 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: 654
    F.1.3Elderly (>=65 years) No
    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 No
    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 state654
    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 Decision2016-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-19
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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