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    Summary
    EudraCT Number:2007-007395-42
    Sponsor's Protocol Code Number:160HF301
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-06-10
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2007-007395-42
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess The Effects of Intravenous BG9928 on Body Weight in Subjects with Acute Decompensated Heart Failure and Renal Insufficiency
    A.3.2Name or abbreviated title of the trial where available
    160HF301 , Trident I
    A.4.1Sponsor's protocol code number160HF301
    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 SponsorBiogen Idec Ltd
    B.1.3.4CountryUnited Kingdom
    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 nameBG9928
    D.3.2Product code BG9928
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INN3-[4-(2,6-dioxo-1,3-dipropyl-2,3,6,7-tetrahydro-1H-purin-8-yl)-
    D.3.9.1CAS number 340021-17-2
    D.3.9.2Current sponsor codeBIO-9002
    D.3.9.3Other descriptive nameBG9928, Adentri
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboPowder for solution for injection
    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
    Acute Decompensated Heart Failure and Renal Insufficiency
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064653
    E.1.2Term Acute decompensated heart failure
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective:
    To assess the effect of BG9928, when added to standard therapy, on the change in body weight at 24 hours following the first dose in subjects hospitalized with ADHF and renal insufficiency.
    E.2.2Secondary objectives of the trial
    Secondary Efficacy Objectives:
    The secondary objectives of this study are to assess the effect of BG9928 when added to standard therapy in subjects with ADHF and renal insufficiency on:
    • Worsening renal function during the double-blind treatment period up to
    Day 5 (or discharge if prior to Day 5).
    • Days of hospital-free survival (DHFS) over 30 days after the first dose of
    study treatment.
    • Improvement in Dyspnea Symptom Score at 6 hours following the first
    dose.
    • Improvement in Subject Global Clinical Assessments at 24 hours following
    the first dose.

    Safety Objectives:
    This study will also assess the safety and tolerability of BG9928, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency as determined by:
    • The incidence of clinical and laboratory adverse events (AEs) and serious adverse events (SAEs) to 30 days following initial dosing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]).
    2. Aged 18 years or older at the time of informed consent.
    3. Must have previous diagnosis of systolic or diastolic heart failure.
    4. Must have ADHF, requiring hospitalization, with clinical evidence for volume overload
    as demonstrated by at least 2 of the following features:
    a. Dyspnea or orthopnea
    b. Rales
    c. Peripheral edema
    d. Increased jugular venous pressure
    e. Chest X-ray consistent with CHF
    f. Plasma BNP ≥150 pg/mL or NT pro-BNP ≥450 pg/mL
    5. Subject requires hospitalization for treatment with IV diuretics for the current episode of ADHF and meets both of the following:
    a. has received at least 40 mg of furosemide (or equivalent) for the treatment of the current episode of ADHF within 24 hours prior to randomization unless a rationalefor a lower dose is provided by the enrolling Investigator, and
    b. is randomized within 24 hours of first dose of IV diuretic administered for this episode of ADHF.
    6. Renal insufficiency at the time of screening as defined by eGFR ≥20 and ≤70 mL/min/1.73 m2 (determined at the site according to the formula in Appendix 1).
    7. Must be able to stand on a standardized scale for weight measurement.
    8. All female subjects of child-bearing potential must practice effective contraception during the study and be willing and able to continue contraception for 2 months after their last dose of study treatment. For further details of contraceptive requirements for this study.
    E.4Principal exclusion criteria
    1. History of an allergic reaction to any xanthine-containing substance.
    2. History of seizure within the past 10 years or use of any medications for the suppression of seizures within the past 5 years.
    3. Within the past 6 months, history of stroke, transient ischemic attack, brain surgery, meningitis/encephalitis, head injury with loss of consciousness or penetrating head trauma.
    4. History consistent with illicit use of drugs or alcohol abuse within 6 months prior to Screening.
    5. Myocardial infarction (MI) or hemodynamically destabilizing arrhythmia (e.g., ventricular fibrillation or hemodynamically significant ventricular or supraventricular tachycardia) within 30 days of Screening.
    6. Cardiac surgery or pacemaker placement within 60 days prior to Screening.
    7. Uncorrected hemodynamically significant primary valvular disease or known obstructive or restrictive cardiomyopathy.
    8. Serious systemic infection (e.g., septicemia) or major surgical procedures within the 30 days prior to Day 1.
    9. Evidence of malignancy within 6 months prior to screening. Subjects with a history of stable prostate cancer, basal cell carcinomas, or fewer than 3 squamous cell carcinomas of the skin are eligible.
    10. Receiving adenosine or xanthine-based agents (e.g., aminophylline, theophylline, pentoxifylline, and dyphylline.)
    11. Receiving clozapine or metronidazole within 5 days of screening (or anticipated use during study drug treatment period).
    12. Current hospitalization initiated by transfer from another acute care inpatient setting.
    13. Acute coronary syndrome (ACS) within 48 hours prior to screening evidenced by significant changes in cardiac biomarkers and electrocardiogram (ECG) changes consistent with ischemia.
    14. Cardiogenic shock as indicated by a systolic blood pressure <80 mmHg or the need for IV inotropes or vasopressors or an intra-aortic balloon pump to maintain adequate blood pressure and/or systemic perfusion.
    15. Respiratory failure at Screening or impending respiratory failure likely requiringinvasive ventilatory support within 8 hours of screening, in the judgment of the enrolling Investigator.
    16. Anticipated need for <48 hours hospitalization from Screening (as judged by the enrolling Investigator).
    17. Anticipated need for cardiac catheterization during the current hospitalization (as judged at Screening by the enrolling Investigator).
    18. Likely to undergo cardiac transplantation, left ventricular assist device (LVAD) or other device implantation, or other cardiac surgery within next 3 months.
    19. Anticipated need for use of ultrafiltration or renal replacement therapy (e.g.,hemodialysis or peritoneal dialysis).
    20. Baseline body weight >150 kg.
    21. Fever, with body temperature >38oC, within the 48 hours prior to first dose.
    22. Screening laboratory findings as follows:
    a. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times the upper limit of normal
    b. Total bilirubin >2.0 mg/dL
    c. Hematocrit <28% or an anticipated need for a blood transfusion
    23. Participation in any other investigational study of drugs or devices within 30 days prior to Screening.
    24. Nursing mothers, pregnant women, or women planning on becoming pregnant during the study.
    25. Presence of any clinically significant (as determined by the Investigator)endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and/or other major disease that might interfere with optimal safe participation in this study.
    E.5 End points
    E.5.1Primary end point(s)
    Change in body weight at 24 hours following the first dose in subjects hospitalized with ADHF and renal insufficiency.
    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 Yes
    E.6.11Pharmacogenomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 Sponsor has defined the End of Study as last subject last visit (LSLV).
    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 months6
    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 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) 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 state29
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 363
    F.4.2.2In the whole clinical trial 900
    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)
    Subjects will revert to standard care after his/her participation in the trial has ended
    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 Decision2008-09-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-11-10
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