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    Summary
    EudraCT Number:2015-004031-12
    Sponsor's Protocol Code Number:AC15007
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-05-23
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2015-004031-12
    A.3Full title of the trial
    Serelaxin To Lower Portal Pressure in Patients with Cirrhosis and Portal Hypertension (STOPP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate whether Serelaxin reduces high blood pressure in the portal vein in people with liver cirrhosis
    A.3.2Name or abbreviated title of the trial where available
    Serelaxin To Lower Portal Pressure (STOPP) study
    A.4.1Sponsor's protocol code numberAC15007
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02669875
    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 SponsorUniversity of Edinburgh
    B.1.3.4CountryUnited Kingdom
    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 supportNovartis Pharmaceuticals UK Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Edinburgh
    B.5.2Functional name of contact pointJonathan Fallowfield
    B.5.3 Address:
    B.5.3.1Street AddressQueens Medical Research Institute
    B.5.3.2Town/ city47 Little France Crescent
    B.5.3.3Post codeEH164TJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01312426655
    B.5.6E-mailJonathan.Fallowfield@ed.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorNHS Lothian
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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 nameSerelaxin
    D.3.2Product code RLX030
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNSerelaxin
    D.3.9.2Current sponsor codeRLX030
    D.3.9.3Other descriptive nameRecombinant human relaxin (rhRlx) or Relaxin
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Portal hypertension in patients with liver cirrhosis.
    E.1.1.1Medical condition in easily understood language
    High blood pressure in the portal vein (which carries blood from the gut and the spleen to the liver) due to extensive scar tissue in the liver (cirrhosis).
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10036200
    E.1.2Term Portal hypertension
    E.1.2System Organ Class 10019805 - Hepatobiliary 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 demonstrate that 2 hours treatment with serelaxin through a drip reduces the portal pressure in patients with liver cirrhosis and high blood pressure in the portal vein.
    E.2.2Secondary objectives of the trial
    To determine the effect of serelaxin treatment on liver blood flow.
    To determine the effect of serelaxin treatment on the general circulation.
    To collect further information on the safety and tolerability of serelaxin in people with liver cirrhosis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male or female adult subjects over 18 years of age
    2) Able to provide written informed consent and able to understand and willing to comply with the requirements of the study
    3) Clinical/imaging-diagnosed or biopsy-proven liver cirrhosis of any aetiology
    4) Evidence of portal hypertension either on imaging or previous endoscopy
    5) Patients with large/grade 3 varices as identified by endoscopy within 6 months of screening must be in an endoscopic band ligation programme at the time of study entry
    6) Suspected hepatic venous pressure gradient (HVPG) ≥10 mmHg at baseline
    E.4Principal exclusion criteria
    1) Pregnancy or nursing (lactating) women
    2) Women of child-bearing potential not using highly effective methods of contraception.

    • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the entire period of the study – until 4 weeks following Visit 2.

    • Further details are found at the following web address: (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01- About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf

    • In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking the investigational drug.

    • Contraception must be continued for up to the end of study – 4 weeks following Visit 2.

    3) Severe liver failure defined by one of the following: Prothrombin activity < 40%, Bilirubin > 5 mg/dL (85umol/L), hepatic encephalopathy > grade I
    4) Presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk
    5) A history of variceal bleed within 1 month prior to visit 1
    6) Hepatocellular carcinoma or history of malignancy of any organ system (other than localized basal cell carcinoma of the skin) treated or untreated.
    7) Portal vein thrombosis
    8) Previous surgical shunt or TIPSS
    9) Current use of beta-blockers or nitrates, any other drug therapy known to have an influence on portal pressure (diuretics permitted provided patients have been on a stable dose for at least 30 days)
    10) History of drug or alcohol abuse within 1 month of enrolment
    11) Sitting Systolic Blood Pressure <110 mmHg at screening visit or within 10 minutes prior to starting study drug infusion
    12) Use of other investigational drugs within 5 half-lives of enrolment, or within 30 days/until the expected pharmacodynamic effect has returned to baseline, whichever is longer
    13) Significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate < 45 beats per minute or atrial fibrillation/flutter with sustained ventricular response of > 90 beats per minute at rest, or Long QT syndrome or QTc > 450 msec (QT correction will be performed using the Fridericia correction method: QTcF = QT/RR0.33) for males and > 460 msec for females at screening (visit 1)
    14) Documented hypersensitivity to intravenous contrast agents and/or iodine
    15) Severe renal impairment (eGFR<30mL/min /1.73m2)
    16) Significant left ventricular outflow tract obstructions (e.g., severe valvular aortic stenosis, obstructive cardiomyopathy), severe mitral stenosis, restrictive amyloid myocardiopathy, acute myocarditis
    17) Severe aortic insufficiency or severe mitral regurgitation for which surgical or percutaneous intervention is indicated
    18) Major neurologic event including cerebrovascular events, within 30 days prior to screening
    19) Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrolment
    20) History of hypersensitivity to study drug serelaxin or study drug ingredients
    21) Inability to follow instructions or comply with follow-up procedures
    22) Permanent pacemaker, cardiac resynchronisation device or implantable cardioverter-defibrillator in situ
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in fasting hepatic venous pressure gradient (HVPG) after 2 hours serelaxin infusion.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 1 hour and 2 hours after initiation of serelaxin infusion.
    E.5.2Secondary end point(s)
    1. Change from baseline in fasting hepatic venous pressure gradient (HVPG) after 1 hour serelaxin infusion.
    2. Change from baseline in fasting hepatic blood flow after 2 hours serelaxin infusion (measured from the concentration of indocyanine green (ICG) in the hepatic venous blood vs peripheral venous blood using the Fick Principle).
    3. Change from baseline in inferior vena cava pressure (IVCP) after 2 hours serelaxin infusion.
    4. Change from baseline in cardiac index (CI) after 2 hours serelaxin infusion.
    5. Change from baseline in systemic vascular resistance index (SVRI) after 2 hours serelaxin infusion.
    6. Change from baseline in aortic pulse wave velocity after 2 hours serelaxin infusion.
    7. Safety and tolerability of serelaxin infusion (as assessed throughout the study by monitoring AEs, clinical laboratory blood tests, heart rate, blood pressure and ECG).
    8. Change from baseline in blood biomarker measurements after 2 hours serelaxin infusion.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline and 1 hour after initiation of serelaxin infusion.
    2. Baseline and 2 hours after initiation of serelaxin infusion.
    3. Baseline and 2 hours after initiation of serelaxin infusion.
    4. Baseline and 2 hours after initiation of serelaxin infusion.
    5. Baseline and 2 hours after initiation of serelaxin infusion.
    6. Baseline and 2 hours after initiation of serelaxin infusion.
    7. Throughout study.
    8. Baseline and 2 hours after initiation of serelaxin infusion.
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    There is currently no provision for continued use of serelaxin at the end of this study. At the end of the study, patients will be treated according to best medical practice.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Wellcome Trust Clinical Research Facility (Epidemiology & Statistics Core)
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-08-31
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