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    Summary
    EudraCT Number:2009-017434-45
    Sponsor's Protocol Code Number:64,185-202
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-01-15
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2009-017434-45
    A.3Full title of the trial
    A Phase 2b, Multicenter, Single-dose, Blinded, Randomized, Placebo-controlled, Dose-escalation, Safety and Efficacy Trial of Stannsoporfin in Neonates with Hyperbilirubinemia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A controlled clinical trial to investigate the safety and effectiveness of Stannsoporfin in newborn children with excess amounts of bilirubin in the blood.
    A.4.1Sponsor's protocol code number64,185-202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00850993
    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 SponsorInfaCare Pharmaceutical Corporation
    B.1.3.4CountryUnited States
    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 supportInfaCare Pharmaceutical Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINC Research
    B.5.2Functional name of contact pointRegulatory Affairs Project Manager
    B.5.3 Address:
    B.5.3.1Street Address1st Floor Suite 220, Vandervell House, Vanwall Business Park
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441628581 161
    B.5.5Fax number441628581180
    B.5.6E-mailSM_Regaffairs_eu_ap@incresearch.com
    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 namestannsoporfin
    D.3.2Product code stannsoporfin
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSTANNSOPORFIN
    D.3.9.1CAS number 106344201
    D.3.9.3Other descriptive nameStanate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) 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 placeboInjection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Neonatal hyperbilirubinemia

    Hiperbilirubinemia neonatal
    E.1.1.1Medical condition in easily understood language
    Neonatal hyperbilirubinemia (newborn jaundice) is a condition marked by high levels of bilirubin in the blood.
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10020580
    E.1.2Term Hyperbilirubinaemia neonatal
    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 determine the safety of 3 ascending doses of stannsoporfin in subjects with hyperbilirubinemia.
    E.2.2Secondary objectives of the trial
    To determine the efficacy and pharmacokinetics (PK) of 3 ascending doses of stannsoporfin in subjects with hyperbilirubinemia. An exploratory pharmacodynamic analysis will examine the relationship between stannsoporfin exposure and change in TSB from Baseline to 48 hours, post dosing of IMP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Term and late preterm subjects (>=35 and <43 weeks gestational age)
    2. Risk factors for hemolytic disease including ABO blood type incompatibility, Rh
    incompatibility (anti-C, c, D, E, or e), or G6PD deficiency.
    3. A minimum birth weight of 2500 g (5.5 lbs)
    4. Coombs positive, or Coombs negative
    - If Coombs negative, one or more of the following risk factors must also be
    present. These include:
    -Jaundice observed in the first 24 hours
    -Previous sibling received phototherapy
    -Cephalohematoma or significant bruising
    -Exclusive breastfeeding
    5. Serum bilirubin within 2 mg/dL below the threshold for PT up to 12 hours of age or within 3 mg/dL below the threshold for PT at ≥12 to 72 hours of age, inclusive
    Note: TcB monitoring may be used for screening purposes, however randomization/treatment cannot take place until the TSB is within 2-3 mg/dL of
    the PT threshold based on age
    6. Willingness for parents/guardians to adhere to recommendations regarding light
    precautions
    7. Written informed consent obtained from parents/guardians
    E.4Principal exclusion criteria
    1. Clinical suggestion of neonatal thyroid disease or current uncontrolled thyroid disease in the mother (maternal Hashimotos disease is not exclusionary)
    2. Treatment or need for treatment in the neonate with medications that may prolong the QT interval (see Appendix C) (erythromycin ointment for eye prophylaxis is permitted), family history of Long QT syndrome or family history of Sudden Infant
    Death syndrome
    3. Known porphyrias or risk factors for porphyrias, including family history
    4. A maternal history of systemic lupus erythematosus
    5. Maternal use of phenobarbital 30 days before, or after delivery, if breast-feeding
    6. Maternal current drug or alcohol abuse, or maternal history of drug or alcohol abuse that, in the opinion of the Investigator, would not make the subject a suitable
    candidate for participation in the clinical trial
    7. Apgar score =< 6 at age 5 minutes
    8 Significant congenital anomalies or infections
    9. Cardiorespiratory distress, defined as a respiratory rate >60 breaths per minute at time of enrollment unless a diagnosis of transient tachypnea of the newborn (TTN) has been made
    10. Any abnormal auditory or ophthalmologic findings at Screening
    - Subjects who fail initial auditory screen may be rescreened
    11. Any excess risk of requiring surgery or exposure to operating room (OR) lights in the foreseeable future
    12. Clinically significant abnormalities on screening laboratory evaluation
    13. Elevated direct or conjugated bilirubin (>1.0 mg/dL if the TSB is <5.0 mg/dL or
    >20% of the TSB if the TSB is >= 5.0 mg/dL)
    14. Persistent hypoglycemia (blood glucose <40 mg/dL) despite standard-of-care
    treatment
    15. Alanine aminotransferase and/or aspartate aminotransferase > 2 times the ULN
    16. Abnormal renal function defined as creatinine and/or blood urea nitrogen >2 times the ULN
    17. Any blood smear finding of structural red cell abnormalities, such as spherocytosis, not caused by isoimmune hemolysis
    18. Temperature instability defined as temperature consistently (3 consecutive times)
    <36ºC and/or >37.5ºC axillary
    19. Use of photosensitizing drugs or agents (see Appendix D)
    20. Use of IVIG or albumins
    21. Postdelivery treatment with medications that are known or suspected to displace
    bilirubin from albumin (eg, ceftriaxone or sulfa-based antibiotics)
    22. Other serious morbid conditions, e.g., pulmonary disease, cardiovascular disease
    23. Exposure to any investigational medications or devices after delivery, or participation in another clinical trial while participating in this trial;
    24. Any other concurrent medical condition, which in the opinion of the Investigator,
    makes the subject unsuitable for the clinical trial
    25. Unwillingness for parents/guardians to adhere to recommendations regarding light precautions
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy outcome will be based on total serum bilirubin (TSB) measurements adjusted for phototherapy (PT) initiation at both baseline and at 48 hours after treatment. In particular, the change in adjusted TSB levels from baseline to 48 hours after treatment will be considered.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Change in adjusted TSB levels from baseline to 48 hours after treatment.
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints are the following:
    - Unadjusted change from baseline to 48 hours in TSB measurements
    - Adjusted and unadjusted change from baseline in TSB measurements at various other timepoints
    - Proportion of subjects who require phototherapy (PT)/exchange transfusion
    - Time to PT/exchange transfusion
    - Duration of PT
    - Time to hospital discharge

    Safety will be based on the following variables:
    - Reported adverse events (AEs)
    - Vital sign measurements
    - Physical examinations
    - Electrocardiogram (ECG) recordings
    - Hearing assessments
    - Vision assessments
    - Neurologic assessments
    - Dermatologic reactions
    - Clinical laboratory tests
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various.
    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 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 trial4
    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.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    India
    Poland
    Spain
    Ukraine
    United States
    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
    Each subject receives only a single dose. End of trial will be the last patient's last visit.
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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 Yes
    F.1.1Number of subjects for this age range: 72
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 20
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 52
    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) No
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    This study is on neonotes. Parents will give consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 72
    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)
    The study involves a once-only administration. If inefficacious, alternative therapy will be given immediately, per normal standard of care.
    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 Decision2010-04-28
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-08-16
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