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    Summary
    EudraCT Number:2011-001472-18
    Sponsor's Protocol Code Number:UDT-2/PHT
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-04-08
    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 number2011-001472-18
    A.3Full title of the trial
    Double-Blind, Randomised, Cross-Over, Placebo-Controlled, Single-Centre Phase IIa Clinical Study on the Influence of Udenafil on the Portal Flow in Cirrhotic Patients with Portal Hypertension
    A.4.1Sponsor's protocol code numberUDT-2/PHT
    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 SponsorSTZ 1172 Gesundheitsförderung und Stoffwechselforschung
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAKP GmbH
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressMunzinger Strasse 1
    B.5.3.2Town/ cityFreiburg
    B.5.3.3Post code79111
    B.5.3.4CountryGermany
    B.5.4Telephone number00490761479400
    B.5.5Fax number004907614794022
    B.5.6E-mailinfo@akp-freiburg.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 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 nameUdenafil
    D.3.4Pharmaceutical form Film-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 INNUdenafil
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Portal hypertension, liver cirrhosis
    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
    To assess the change in portal blood flow by ultrasonography in patients with portal hypertension.
    E.2.2Secondary objectives of the trial
    Change of hepatic blood flow measured by ICG-Clearance after single study drug administration.
    Change of time interval of ultrasound contrast media appearing in a liver vein after i.v. injection.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Signed informed consent.
    2.Man or woman between 18 and 70 years of age.
    3.Liver cirrhosis as proven by clinical findings, laboratory tests, and ultrasound.
    4.One of the following:
    a)HVPG ≥ 10 mm Hg measured within the last 24 months or
    b)Varices proven by endoscopy or
    c)Varices with history of bleeding (but: no bleeding within the last 4 weeks before baseline) or
    d)Ascites or
    e)Anamnestic ascites.
    5.Women of child-bearing potential have to apply double barrier methods of contraception (e.g. oral contraception with condom) or a highly effective method of birth control which is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptive method, some IUDs, sexual abstinence or vasectomised partner. The investigator is responsible for determining whether the patient has adequate birth control for study participation.
    E.4Principal exclusion criteria
    1.Child-Pugh C.
    2.Existing transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunt.
    3.Splenic, mesenteric or portal vein thrombosis by Doppler ultrasonography, magnetic resonance imaging.
    4.Retrograde perfusion in portal vein or both branches, collateral blood flow more than 1/3 of the volume of portal blood flow
    5.Hepatic encephalopathy ≥ stage 2.
    6.Total Bilirubin > 3.5 mg/dl.
    7.Bleeding disorder, INR > 2.
    8.Active peptic ulceration.
    9.Anatomical deformation of the penis or penile implants.
    10.Predisposing priapism, sickle cell anaemia, thrombocythaemia, polycythaemia, prone to venous thrombosis, hyperviscosity syndrome.
    11.Known hereditary degenerative retinal disorders, including retinitis pigmentosa.
    12.Previous episode of NAION.
    13.Renal failure (GFR < 40 ml/min/1.73 m²).
    14.QTc prolongation or treatment with QTc interval-increasing medications.
    15.Heart failure (NYHA II-IV).
    16.Angina pectoris.
    17.History of myocardial infarction, stroke or life-threatening arrhythmia.
    18.Aortic stenosis.
    19.Resting hypotension (systolic blood pressure [SBP]/diastolic blood pressure [DBP] < 90/60 mm Hg), uncontrolled hypertension (SBP/DBP > 170/100 mm Hg).
    20.Bacterial infection (CRP > 2 x ULN, positive blood, urine or ascites cultures; or ascites with leucocytes ≥ 500/µl or PMN ≥ 250/µl) within 2 weeks prior to Baseline visit.
    21.Change of regular medication and/or dosage change of drugs that may have an effect on splanchnic haemodynamics/portal pressure, e.g. β-blockers, clonidine, prazosin, and any other antihypertensive treatment within 2 weeks prior to Baseline visit (Exception: losartan within 4 weeks prior to Baseline visit).
    22.Concomitant treatment with NO-donors as nitrates, molsidomine or β-blockers.
    23.Concomitant treatment with vasopressin or somatostatin and their derivatives and analogues.
    24.Concomitant treatment with platelet aggregation inhibitors, e.g. aspirin or anticoagulant, e.g. heparin.
    25.Concomitant treatment with other PDE-5 inhibitors, e.g. sildenafil, tadalafil or vardenafil.
    26.Treatment with ketoconazole or other CYP3A inhibitors or inducers, consumption of grapefruit juice within one week prior to Baseline visit
    27.Active hepatocellular cancer or a history of hepatocellular cancer (to be excluded by ultrasound and tumour markers).
    28.Active malignancy other than hepatocellular cancer or treatment with anticancer drugs during the last 5 years. Patients with a history of cancer other than hepatocellular cancer and at least five years of uneventful follow up and no signs of recurrence may be eligible.
    29.Severe co-morbidity substantially reducing life expectancy.
    30.Known intolerance/hypersensitivity/resistance to study drug or drugs of similar chemical structure or pharmacological profile.
    31.Hypersensitivity to indocyanine green or sodium iodide, allergy to iodine, manifest hyperthyroidism, autonomous thyroid adenoma, focally or diffuse autonomies of thyroid gland.
    32.Doubt about the patient’s cooperation, e.g. because of addiction to alcohol or drugs.
    33.Existing or intended pregnancy or breast-feeding.
    34.Participation in another clinical study within the last 30 days, simultaneous participation in another clinical study, or previous participation in this study.
    E.5 End points
    E.5.1Primary end point(s)
    Change of portal flow measured by change in following haemodynamic parameter (Doppler ultrasonography):
    -Flow volume in the portal vein after single study drug administration
    E.5.1.1Timepoint(s) of evaluation of this end point
    First and second study day.
    E.5.2Secondary end point(s)
    •Change of portal flow measured by changes in following haemodynamic parameters (Doppler ultrasonography):
    -Maximal and time-averaged mean blood velocity in portal vein
    -Diameter of the portal vein
    -Resistivity indices in the common hepatic artery, splenic artery, celiac trunk and superior mesenteric artery
    -Time span of ultrasound contrast media appearance after injection into a cubital vein
    •Change of hepatic blood flow measured by ICG-Clearance after single study drug or placebo administration
    •Effect on systemic blood circulation
    E.5.2.1Timepoint(s) of evaluation of this end point
    First and second study day.
    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 No
    E.8.1.6Cross over Yes
    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.8.5The 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
    Last patient out (LPO)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    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: 20
    F.1.3Elderly (>=65 years) Yes
    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 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)
    There is no difference to what is normally expected from the treatment of the patient after the individual study.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-26
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