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    Summary
    EudraCT Number:2007-001711-31
    Sponsor's Protocol Code Number:M0002-BEL-C201
    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:2008-02-22
    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 number2007-001711-31
    A.3Full title of the trial
    A randomized, double blind, placebo controlled, phase II, dose-titration trial to explore the safety, tolerability, pharmacokinetic profile and efficacy of M0002 in cirrhotic subjects with ascites and hypo- or normonatremia.
    A.4.1Sponsor's protocol code numberM0002-BEL-C201
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMovetis NV
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 nameM0002
    D.3.2Product code M0002
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeM0002
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,3
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 nameM0002
    D.3.2Product code M0002
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeM0002
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboCapsule*
    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
    Cirrhotic subjects with ascites and hypo- or normonatraemia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10009213
    E.1.2Term Cirrhosis of liver
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003445
    E.1.2Term Ascites
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10021038
    E.1.2Term Hyponatremia
    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 safety and tolerability of M0002 after multiple oral dosing compared with placebo.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of M0002 after multiple oral dosing compared with placebo.

    To assess the pharmacokinetic behavior and relationship of the plasma drug concentration with the required effect of M0002 after multiple doses.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female. Female subjects should be postmenopausal: prior oophorectomy, amenorrheic for 12 months or more in the absence of chemotherapy, tamoxifen, toremifene or ovarian suppression and follicle stimulating hormone and plasma estradiol in the postmenopausal range.
    2. 18 – 75 years of age inclusive.
    3. Subjects with any form of cirrhosis with ascites on diuretic treatment and who had at least 1 paracentesis of at least 4 liter in the last 6 months.
    4. The diagnosis of cirrhosis must be confirmed by clinical findings such as evidence of portal hypertension (prominent abdominal wall veins, oesophageal varices, hypersplenism) and / or abnormal laboratory tests (LFTs, coagulation disorders (prolonged coagulation time), low platelet count, anaemia, low albumin, low total protein. The presence of ascites must be documented by ultrasound imaging. Duration since diagnosis should be noted.
    5. Dose of diuretics of spironolactone and furosemide should be stable for at least one week prior to the screening visit.
    6. Subjects must have been on a salt restricted diet (< 5.2 grams sodium/day, 90 mmol) during the screening period prior to the trial drug administration.
    7. Subjects (or their legally acceptable representatives) must have read and signed the written informed consent form after the nature of the trial has been fully explained, indicating the subject understands the purpose of and procedures required for the trial and is willing to comply with trial procedures and restrictions.
    8. Other treatment for the management of cirrhosis and ascites should be stable for at least 2 weeks prior to trial drug administration.
    9. Child-Pugh B and C (< 12) liver cirrhosis.
    10. Subjects with hyponatraemia with sodium level between 120 and 132 mmol/L or normonatraemia with sodium level between 133 and 145 mmol/L measured at screening visit and day 1.
    E.4Principal exclusion criteria
    1. Women of child bearing potential (WOCBP).
    2. Alcohol or drug abuse 4 weeks prior to screening and/or positive test at screening.
    3. Malignancy.
    4. Known renal impairment (serum creatinine > 2 mg/dL or 24-h creatinine clearance < 40 ml/min).
    5. Recent infection (e.g. urinary tract infection, bacteremia, pneumonia, cellulitis) requiring treatment with antibiotics (e.g. ciprofloxacin, norfloxicin) within 14 days prior to trial entry. Long term, prophylactic antibiotic use is not excluded.
    6. Surgery requiring general anesthesia within 30 days prior to trial entry.
    7. Major pulmonary insufficiency.
    8. Head trauma in the past 2 weeks.
    9. Adrenal insufficiency, active encephalopathy grade II, uncontrolled hypo- or hyperthyroidism, unstable diabetes.
    10. Subjects with spontaneous bacterial peritonitis (confirmed by culture) within 10 days prior to trial drug administration.
    11. Gastrointestinal bleed within 10 days prior to trial drug administration.
    12. Functional transjugular intrahepatic portasystemic stent shunt (TIPS), peritoneovenous shunt
    13. Liver transplantation.
    14. Budd-Chiari syndrome
    15. Evidence of intravascular hypovolemia or major hemodynamic instability defined as systolic arterial pressure < 80 mm Hg, orthostatic hypotension, and pulse rate > 120 beats per minute.
    16. Any evidence of active myocardial ischemia, myocardial infarction in the last 6 months.
    17. Subjects with clinically relevant abnormal ECG intervals of morphology of the ECG, QTc > 480 ms.
    18. Positive HIV test.
    19. Hemoglobin < 9 g/dL.
    20. Unstable hepatic disease (acute hepatitis, AST or ALT > 5 x upper limit of normal, bilirubin > 10 mg/dL)
    21. Serum potassium > 6.0 mmol/L or < 3 mmol/L, osmolality > 295 mOs/kg.
    22. Platelet count < 40 x 10³ / mm³.
    23. Significant coagulopathy such as INR > 2.
    24. Participation in an investigational drug or device trial within 30 days prior to screening.
    25. Use of the following therapeutic agents: salt tablets or hypertonic saline, NSAIDs, corticosteroids, anticoagulants, saline solution, vasopressin analogs, DDAVP, lithium, demeclocycline, oncologic agents, drugs with potent CYP 3A4 inhibitors (such as itraconazole, ketoconazole, erythromycin, ritonavir, indinavir, sequinavir, …) or drugs known to affect platelet function within 14 days prior to trial drug administration.
    26. Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the subjects to comply with the trial requirements.
    27. Any condition that in the opinion of the investigator(s) would complicate or compromise the trial or the well being of the subject or evidence of clinically relevant pathology that could interfere with the trial results or put the subject’s safety at risk.
    28. Signs of clinical dehydration
    E.5 End points
    E.5.1Primary end point(s)
    To assess the safety and tolerability of M0002 after multiple oral dosing compared with placebo
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Dose titration
    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.8.3 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 Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    The trial will take an end three days after a 15-days treatment period. The total duration of the trial will be 32 days incl. 14 days for screening.
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 12
    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)
    During the trial, current treatment with diabetics, furesomide and spironolactone, will not be interrupted, as a consequence subject will continue to receive the diuretics after stop of trial medication.
    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 Decision2007-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-12-21
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