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    Summary
    EudraCT Number:2015-000253-21
    Sponsor's Protocol Code Number:CLA-CC10-02
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-27
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-000253-21
    A.3Full title of the trial
    Efficacy of recombinant human club (clara) cell 10kDa protein (CC10) administered to premature neonates with respiratory distress syndrome.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of recombinant human club (clara) cell 10kDa protein (CC10) administered to premature neonates with respiratory distress syndrome.
    A.4.1Sponsor's protocol code numberCLA-CC10-02
    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 SponsorTherabron Therapeutics Inc.
    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 supportTherabron Therapeutics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Consulting
    B.5.2Functional name of contact pointTadeusz Baron
    B.5.3 Address:
    B.5.3.1Street Addressul. Dzwonkowa 104
    B.5.3.2Town/ cityTychy
    B.5.3.3Post code43-100
    B.5.3.4CountryPoland
    B.5.4Telephone number0048322272005
    B.5.5Fax number0048323298426
    B.5.6E-mailtadeusz.baron@clinicalconsulting.pl
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/15/1456 - EMA/OD/270/14
    D.3 Description of the IMP
    D.3.1Product namerhCC10
    D.3.4Pharmaceutical form Endotracheopulmonary instillation, solution
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntratracheal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNrhCC10 protein (recombinant human Club Cell 10 kDa protein)
    D.3.9.2Current sponsor coderhCC10
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboEndotracheopulmonary instillation, solution
    D.8.4Route of administration of the placeboIntratracheal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bronchopulmonary Dysplasia (BPD)
    E.1.1.1Medical condition in easily understood language
    Bronchopulmonary Dysplasia (BPD)
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006475
    E.1.2Term Bronchopulmonary dysplasia
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of a single intratracheal dose of rhCC10 (1.5mg/kg and 5mg/kg in a 2 ml/kg fixed volume) in improving survival without chronic respiratory morbidity as indicated by a reduction in respiratory complications at 12 months corrected gestational age.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Age ≤ 24 hours;
    •Birthweight between 600 and 1,250 grams;
    •Gestational age 24-29 weeks (not less than 24 weeks); at birth based on best estimate using obstetrical sonography (first or second trimester), solid dating criteria, or Ballard examination;
    •Birthweight appropriate for gestational age;
    •5 minute Apgar score >5;
    •Diagnosis of neonatal RDS based on clinical and radiographic criteria;
    •Requiring intubation and mechanical ventilation for treatment of RDS;
    •Received at least one dose of surfactant (prophylaxis or rescue) or the decision to treat with surfactant has already been made (e.g. infant is intubated or in the process of being intubated and/or surfactant has been prescribed); and
    •Written informed consent is obtained from the infant’s parent or legal guardian prior to enrollment of the patient and agrees to all study-related procedures and evaluations, including those required after hospital discharge.
    E.4Principal exclusion criteria
    •5 minute Apgar score of ≤ 5; except in cases where the subject’s Apgar score is ≤ 5 at 5 minutes, normalizes by 10 minutes, no acidosis is present on cord blood gas and the neonatal depression is thought to be due to maternal anesthesia or other drug exposure such as MgSO4.
    •Major congenital abnormalities (chromosomal, renal, cardiac, hepatic, neurologic, or pulmonary malformations; minor anomalies such as cleft lip/palate are permitted);
    •Evidence of severe neonatal depression (as defined by cord blood pH ≤ 7.00 and/or an Apgar score of < 4 at 10 minutes);
    •Evidence of congenital infection (bacterial or non-bacterial) ;
    •Requires a major surgical procedure prior to administration of Study drug
    •Enrollment in any other study involving administration of another investigational drug;
    •Any condition which could preclude receiving study drug or performing any study-related procedures;
    •Use of postnatal corticosteroids prior to administration of rhCC10, except as specified in the protocol;
    •Use of inhaled nitric oxide prior to administration of rhCC10;
    •Mother is known to be seropositive for HIV or HTLV-1 (per maternal medical records);
    •Parent or guardian is unable or unwilling to complete the study diary after hospital discharge;
    •Parent or guardian is unable to bring the infant back to the study center for follow-up evaluations after discharge.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome of the study will be survival without CRM at 12 months CGA as measured by a validated respiratory diary based scoring system (presence of wheezing and/or coughing 2 days per week for 3 consecutive weeks) and pulmonary questionnaires (decrease in respiratory illness requiring medications, unscheduled medical visits and/or ER or hospital admissions) which have been shown to correlate closely with abnormalities on pulmonary function testing. The 12 month CGA endpoint has been shown to be more predictive of respiratory morbidity at two years of life than a diagnosis of BPD at 36 weeks CGA in previous studies of high frequency oscillatory ventilation in preterm infants.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 days per week for 3 consecutive weeks then once a month during 12 months
    E.5.2Secondary end point(s)
    1) Long Term Efficacy – 6 & 18 months
    A secondary outcome of the study will be survival without CRM at 6 months CGA as measured by validated respiratory diaries (presence of wheezing and/or coughing 2 days per week for 3 consecutive weeks) and pulmonary questionnaires (decrease in respiratory illness requiring medications and/or hospitalization) which have been shown to correlate closely with abnormalities on pulmonary function testing. Infants will be also be evaluated by physical examinations at 18 months CGA to evaluate growth and neurological development.

    2) Short Term Efficacy
    Short term efficacy evaluations will include time of mechanical ventilation, oxygen requirement at 36 weeks CGA, and survival without BPD at 36 weeks CGA (or NICU discharge) as measured by oxygen challenge testing. Oxygen challenge testing involves the withdrawal of supplemental oxygen for a 30 minute period, during which the infant is closely monitored. At the end of the 30’ period, oxygenation is measured by pulse oximetry and the infant is placed back on supplemental oxygen. The infant’s BPD status is then determined by oxygen saturation; a diagnosis of BPD will be made if the infant’s oxygen saturation is 90% or less (<90%) at or before the end of the thirty minute period. If the infant’s oxygen level remains above 90% for the entire period, then the diagnosis will be “No BPD”.
    Failure to complete the test due to respiratory distress would be scored as severe BPD. The severity of BPD will be assessed using NIH consensus guidelines for infants born at <32 weeks PMA based on oxygen requirements at 28 days post-natal age and at 36 weeks PMA or at NICU discharge (whichever comes first).

    3) Safety and Efficacy - Adverse Events
    The safety of the study drug will continue to be assessed by comparing the incidence of adverse events and serious adverse events in the treatment and placebo groups to each other and to the historical incidence of the adverse events at each institution. Safety evaluations will include all serious adverse events up to at least 12 months CGA, and routine laboratory monitoring prior to NICU discharge (CBC, electrolytes, liver function studies, urinalysis, head ultrasound). In addition to evaluating the safety of rhCC10, preliminary efficacy of rhCC10 in this patient population may also be indicated by decreases in the numbers of all SAEs and/or specific types of SAEs (ie. IVH, PVL, ROP, sepsis, infection, etc.).
    E.5.2.1Timepoint(s) of evaluation of this end point
    See descriptions of secondary endpoints
    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 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 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 trial3
    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 EEA5
    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
    France
    Germany
    Poland
    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
    LVLS
    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 months8
    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 months10
    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: 88
    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: 88
    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) 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
    Paediatric patients
    Premature babies
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 46
    F.4.2.2In the whole clinical trial 88
    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)
    none
    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 Decision2015-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-29
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