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    Summary
    EudraCT Number:2007-005679-33
    Sponsor's Protocol Code Number:KKSH-042
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-10-04
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-005679-33
    A.3Full title of the trial
    Influence of the selective endothelin receptor-blocker Ambrisetan on the portal pressure in patients with cirrhosis
    Einfluss des selektiven Endothelin-Rezeptorblockers Ambrisentan auf den portalen Druck bei Patienten mit Zirrhose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Influence of the selective endothelin receptor-blocker Ambrisetan on the portal pressure in patients with cirrhosis
    Einfluss des selektiven Endothelin-Rezeptorblockers Ambrisentan auf den portalen Druck bei Patienten mit Zirrhose
    A.3.2Name or abbreviated title of the trial where available
    ADAPT-Studie
    A.4.1Sponsor's protocol code numberKKSH-042
    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 SponsorMedizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg
    B.1.3.4CountryGermany
    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 supportMartin-Luther-Universität Halle Wittenberg
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Halle
    B.5.2Functional name of contact pointKlinik für Innere Medizin I
    B.5.3 Address:
    B.5.3.1Street AddressErnst-Grube-Strasse 40
    B.5.3.2Town/ cityHalle (Saale)
    B.5.3.3Post code06120
    B.5.3.4CountryGermany
    B.5.4Telephone number+493455572665
    B.5.5Fax number+493455572253
    B.5.6E-mailalexander.zipprich@uk-halle.de
    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 Volibris 10 mg
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMBRISENTAN
    D.3.9.1CAS number 0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.3.11.13.1Other medicinal product typezur Klasse der Propionsäuren gehörender ERA mit Selektivität für den Endothelin-A-(ETA-)Rezeptor
    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
    Portal hypertension and hepatic cirrhosis
    Portale Hypertonie und Leberzirrhose
    E.1.1.1Medical condition in easily understood language
    Portal hypertension and hepatic cirrhosis
    Portale Hypertonie und Leberzirrhose
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10036200
    E.1.2Term Portal hypertension
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10009213
    E.1.2Term Cirrhosis of liver
    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
    Efficacy of endothelin receptor-blocker on the portal pressure.
    Normalizing of the initial increased hepatic vascular resistance or reduction of the values for 10% at minimum during therapy with endothelin-A-receptor-antagonists.
    Wirksamkeit der Endothelin-Rezeptor-Blockade auf den portalen Druck.
    Normalisierung des initial erhöhten hepatischen Gefäßwiderstandes oder eine Reduktion der Werte um mindestens 10% unter Medikation des Endothelin-A-Rezeptor-Antagonisten.
    E.2.2Secondary objectives of the trial
    Assessment of the change of the portal pressure after application of the endothelin-receptor-blocker
    Erfassung der Größenänderung des portalen Drucks nach Gabe des Endothelin-Rezeptor-Blockers
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically/ laboratory or sonographically confirmed diagnosis of hepatic cirrhosis
    - Compensated hepatic disease (Child A and B)
    - Portal hypertension
    - Age: 18 - 75
    - Signed, written informed consent
    - Histologisch/ laborchemisch oder sonographisch gesicherte Leberzirrhose
    - Kompensierte Lebererkrankung (Child A und B)
    - Portale Hypertension
    - Alter: 18 - 75
    - Durchgeführte Aufklärung des Patienten, schriftliche Einwilligung; die Einwilligungsfähigkeit des Patienten ist gegeben
    E.4Principal exclusion criteria
    - Acute infection
    - Hepatic encephalopathy Stadium II- IV
    - Alcoholic hepatitis and other acute manifestations of hepatitis
    - Pylethrombosis
    - Transaminases increased > 3 x UNL
    - Advanced stadium of cardiac and/or pulmonary preventing head-down position
    - Evidence of known advanced malignant disease
    - Usage of beta-blockers within the last 72 hours
    - Pregnancy or lactation
    - Participation in another clinical trial
    - Marked hypotension (systolic blood pressure less than 90 mmHg )
    - Advanced hepatic disease (stadium Child C)
    - Akute Infektion
    - Hepatische Enzephalopathie Stadium II- IV
    - Alkoholische Hepatitis und andere akute Hepatitisformen
    - Pfortaderthrombose
    - Transaminasenerhöhung über das Dreifache der Norm
    - Fortgeschrittenes Stadium einer Herz- und/oder Lungenerkrankung, welche eine Kopf-Tief-Lage verhindert
    - Bekanntes fortgeschrittenes Tumorleiden
    - Einnahme von Betablocker in den letzten 72 Stunden
    - Schwangerschaft oder Stillzeit
    - Gleichzeitige Teilnahme an einer anderen klinischen Prüfung
    - ausgeprägte Hypotonie (systolischer Blutdruck unter 90 mmHg )
    - Fortgeschrittene Lebererkrankung im Stadium Child C
    E.5 End points
    E.5.1Primary end point(s)
    Normalisazion of the initially increased portal pressure or reduction of 10% minimum compared to the initial value will be defined as binary end point with the characteristic values achieved/not achieved.
    Die Normalisierung des initial erhöhten portalen Drucks oder eine Reduktion um mindestens 10% im Vergleich zum Ausgangswert werden als binäre primäre Zielgröße mit den Ausprägungen erreicht/nicht erreicht definiert.
    E.5.1.1Timepoint(s) of evaluation of this end point
    One day after application of study treatment
    Ein Tag nach Applikation der Studienmedikation
    E.5.2Secondary end point(s)
    Reduction of endothelin-1 concentration
    Senkung der Endothelin-1 Konzentration
    E.5.2.1Timepoint(s) of evaluation of this end point
    One day after application of study treatment
    Ein Tag nach Applikation der Studienmedikation
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.5The 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 Information not present in EudraCT
    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
    See study protocol section 8.
    Eine weitere Nachkontrolle der Patienten ist vier Wochen nach der Untersuchung geplant. Da die Teilnehmer der Studie mit einer chronischen Erkrankung behaftet sind, sind sie bereits an die hepatologische Ambulanz angebunden und werden sich dort in regelmäßigen Abständen zur weiteren Versorgung vorstellen
    siehe Prüfplan Abschnitt 8.
    A follow-up visit is foreseen 4 weeks after study treatment. All trial paricipants suffer from a chronic disease. They will be monitored routinely at the hospital hepatological unit.
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial 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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 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 state24
    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)
    See study protocol section 6.4
    Treatment or care after the subject has ended the participation in the trial is not different from the expected normal treatment of that condition.
    Siehe Prüfplan Abschnitt 6.4
    Die Behandlung und Nachsorge der Studienpatienten nach Ende der Teilnahme unterscheidet sich nicht vom normalen Vorgehen bei Patienten mit diesen Erkrankungen.
    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 Decision2011-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-12-12
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