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    The EU Clinical Trials Register currently displays   42330   clinical trials with a EudraCT protocol, of which   6971   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-001199-31
    Sponsor's Protocol Code Number:57231
    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:2017-02-02
    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 number2016-001199-31
    A.3Full title of the trial
    Improving treatment of right ventricular failure in pulmonary hypertension patients.
    Het verbeteren van de behandeling van rechter hartfalen in patiënten met pulmonale hypertensie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Improving treatment of right heart failure in patients with pulmonary hypertension.
    Het verbeteren van de behandeling van rechter hartfalen in patiënten met pulmonale hypertensie.
    A.3.2Name or abbreviated title of the trial where available
    Improving treatment of RHF in PH patients.
    Het verbeteren van de behandeling van RHF in PH patiënten
    A.4.1Sponsor's protocol code number57231
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 Terlipressin
    D.2.1.1.2Name of the Marketing Authorisation holderSun Pharmaceutical Industries Europe 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.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    End stage right ventricular failure in pulmonary hypertension patients
    Eindstadium rechter hartfalen in patiënten met pulmonale hypertensie.
    E.1.1.1Medical condition in easily understood language
    End stage right heart failure in patients with pulmonary hypertension.
    Eindstadium rechter hartfalen in patiënten met hoge bloeddruk in de longen.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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 explore efficacy and safety of terlipressin as add on therapy to loop diuretics in patients with pre-capillary pulmonary hypertension who are hospitalized for right ventricular failure.
    Het effect van het toevoegen van terlipressine aan lisdiuretica als
    behandeling van eindstadium rechterventrikelfalen in patiënten met
    pulmonale arteriële hypertensie of chronische trombo-embolische
    pulmonale hypertensie onderzoeken.
    E.2.2Secondary objectives of the trial
    Not applicable
    N.v.t.
    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 should be diagnosed with pre-capillary pulmonary hypertension either PAH or CTEPH, have clinical signs of decompensated right heart failure, and needing hospital - or ICU admission for IV diuretics.
    • PAH (group 1 and 1’) or CTEPH (group 2), diagnosed according ESC/ERS guidelines;
    o Mean Pulmonary Artery Pressure (mPAP) ≥ 25 mmHg
    o Pulmonary Arterial Wedge Pressure (PCWP) <15 mmHg
    o Other possible causes of PH are excluded
    • 18-70 years old
    • Increased body weight despite increased dose diuretics in past month
    • Clinical signs of decompensated right heart failure: ankle edema and/or ascites
    • eGFR > 30 ml/min/1.73m2
    • Sinus rhythm
    Om aan de studie te kunnen deelnemen moet de patiënt voldoen aan de
    volgende inclusiecriteria:
    - Patiënt is gediagnosticeerd met PAH of CTEPH, klinische tekenen
    hebben van decompensatio cordis en klinische opname ter behandeling
    is noodzakelijk.
    - Patiënt is gediagnosticeerd met PAH of CTEPH volgens de ESC/ERS
    guidelines; d.w.z.: een gemiddelde pulmonaal arterie druk (MPAP) ≥ 25
    mmHg, een pulmonaal arterie wiggedruk <15 mmHg, geen andere
    oorzaken bekend voor het veroorzaken van de pulmonale hypertensie.
    • Leeftijd ≥18 jaar oud
    • Toename in lichaamsgewicht, ondanks het ophogen van de dosis
    diuretica in de afgelopen maand.
    • Leeftijd 18-70 jaar
    • Klinische tekenen van rechts decompensatio cordis; enkel oedeem
    en/of ascites.
    • eGFR > 30 ml/min/1.73m2
    • Sinus ritme
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    • Pulmonary hypertension due to connective tissue disease, and PH due to left heart disease (group 2).
    • Hypoxia defined as SaO2 ≤80% and/or ≤ 90% with oxygen suppletion.
    • Pregnancy, lactation
    • Anuria (urine production <50 ml/day)
    • Known intolerance of loop diuretics or terlipressin
    • Recent diagnosis (<1 month ago) of acute pulmonary embolism
    • Underlying infectious disorder/ bacteremia
    • Known history of occlusive arterial disease (e.g. coronary artery disease) and/or peripheral artery disease, exception: pulmonary embolism
    • Type 1 and type 2 diabetes mellitus
    • Chronic use of NSAIDs
    • Pre-existing renal failure from other causes than forward failure (eg diabetes)
    Een potentiële deelnemer die voldoet aan een van de volgende criteria
    zal worden geëxcludeerd van deelname in deze studie:
    - Pulmonale arteriële hypertensie door bindweefsel ziekte
    -Hypoxie gedefineerd als een SaO2 ≤80% en/of ≤ 90% met
    zuurstofsuppletie.
    - Zwangerschap, geven van borstvoeding
    - Anurie (urine productie <50 ml/day)
    - Bekende intolerantie voor lisdiuretica of terlipressine.
    - Recente diagnose van acute longembolie ( <1 maand geleden)
    - Onderliggende infectie
    - Bekende voorgeschiedenis van arterieel vaatlijden (bijv. coronair lijden)
    - Diabetes mellitus
    - Chronisch NSAID gebruik
    - Pre-existent nierfalen door een andere oorzaak dan forward failure.
    E.5 End points
    E.5.1Primary end point(s)
    The aim of this study is: “To explore efficacy and safety of terlipressin as add on therapy to loop diuretics in patients with pre-capillary pulmonary hypertension who are hospitalized for right ventricular failure.” Change in creatinine after 48 hours, is considered as a primary safety endpoint. Endpoint assessment will be after 48 hours and when, in opinion of the clinician an optimal volume status of the patient is reached. Primary efficacy endpoint will be weight loss over the first 48 hours after start of drug administration. This study is considered positive when: The weight loss after 48h is higher in the terlipressin treated patients and change in creatinine is smaller or not significantly increased compared to patients who are treated with loop diuretics alone.
    Primair veiligheids eindpunt: verandering in kreatinine na 48 uur
    Primair effectiviteits eindpunt: gewichtsafname na 48 uur
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hours
    48 uur
    E.5.2Secondary end point(s)
    Other study parameters and endpoints are:
    • Fluid balance (= Fluid intake – urine output) after 48h
    • Urine output after 48h
    • Final dose of loop diuretics at 48h
    • Time interval from treatment start to accomplishing an optimal volume status/ time to dismissal
    • Change in creatinine at t = 48h, t = 72h and at dismissal
    • N-terminal brain-type natriuretic peptide (NT-proBNP) levels
    • Total weight loss at dismissal
    • Total urine output at dismissal
    • Need for additional treatment (in both treatment arms)
    - Vochtbalans
    - Diurese
    - Dosis lisdiuretica
    - Opnameduur en behandelduur tot bereiken optimaal gewicht
    - Verandering in creatinine op t= 48 uur, t= 72 uur en ten tijde van ontslag
    - Nt-pro-BNP
    - Totaal gewichtsverlies op t= 72 h en ten tijde van ontslag
    - Totale urine output ten tijde van ontslag
    - Aanvullende behandelingen
    E.5.2.1Timepoint(s) of evaluation of this end point
    See E.5.2
    Zie E 5.2
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 Yes
    E.8.2.3.1Comparator description
    Standard clinical care with loop diuretics. Terlipressin is an add-on product.
    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 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 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
    The trail will be closed when the last subject is dismissed from the hospital.
    De studie zal eindigen wanneer de laatste studiepatiënt is ontslagen uit het ziekenhuis.
    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 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: 17
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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)
    After 48h patients will be treated according to best clinical practice.
    Na 48 uur zullen de studiepatiënten de standaardbehandeling krijgen, hiervoor ligt de keuze bij de behandelend arts.
    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 Decision2017-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-20
    P. End of Trial
    P.End of Trial StatusOngoing
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