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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41018   clinical trials with a EudraCT protocol, of which   6709   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2018-001667-24
    Sponsor's Protocol Code Number:PC_RSV_004
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-06-13
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-001667-24
    A.3Full title of the trial
    A double blind, placebo-controlled study to assess the anti-viral effect, safety and tolerability of inhaled PC786 for the treatment of acute respiratory syncytial virus (RSV) infection in adult hematopoietic stem cell transplant recipients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to understand the effects of treating a respiratory infection caused
    by the respiratory syncytial virus (RSV) using drug PC786, in adults that
    have received a blood stem cell transplant.
    A.4.1Sponsor's protocol code numberPC_RSV_004
    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 SponsorPulmocide 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 supportPulmocide Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPulmocide Ltd
    B.5.2Functional name of contact pointDirector of Clinical Development
    B.5.3 Address:
    B.5.3.1Street Address52 Princes Gate, Exhibition Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSW7 2PG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+447766250133
    B.5.6E-mailLindsey@pulmocide.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 namePC786
    D.3.4Pharmaceutical form Powder for nebuliser suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.2Current sponsor codePC786
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 placeboNebuliser solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Respiratory Syncytial Virus
    E.1.1.1Medical condition in easily understood language
    Viral infection of the lungs and airways
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10061603
    E.1.2Term Respiratory syncytial virus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To evaluate the anti-viral effect of inhaled PC786 compared with
    placebo when added to standard of care (SoC) RSV treatment in
    haematopoietic stem cell transplant (HSCT) recipients with acute RSV
    infection
    •To assess the safety and tolerability of 3 days of inhaled PC786 in HSCT subjects with acute RSV infection
    E.2.2Secondary objectives of the trial
    •To compare the anti-viral effect of PC786 with that of placebo on RSV
    load measured in nasal secretions
    •To obtain estimates of PC786 concentrations in nasal MLF and plasma
    •To evaluate the effect of PC786 on clinical features of RSV disease
    •To evaluate the effect of PC786 in preventing development of lower
    respiratory tract infection (LRTI) in subjects with infection confined to
    the upper respiratory tract (URT) at enrolment
    •To obtain estimates for important clinical endpoints
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Any potential study subject must satisfy all of the following criteria to be
    eligible to enter the study. The subject is/has:
    1.Received an allogeneic or autologous HSCT using any conditioning
    regimen
    2.Experienced new onset of at least one of the following respiratory
    symptoms ≤5 days before study Day 1: Nasal congestion or stuffiness, runny nose (rhinorrhoea), cough, or sore throat OR worsening of at least one of these symptoms, if these symptoms are chronic (i.e., associated with a prior diagnosis, such as chronic rhinorrhoea, seasonal allergy or chronic lung disease) OR wheezing, sputum production, pleuritic chest pain, increased respiratory rate, signs on chest auscultation, hypoxia, increased supplemental oxygen requirement or new infiltrates on chest
    X-ray or computerised tomography thorax
    3.A positive RSV diagnostic test result on a sample collected from the nose or pharynx ≤2 days before Day 1 (may be ≤3 days before Day 1
    only if the sample is collected on a Friday)
    4.Provided written informed consent
    5.Aged ≥18 years of age at the time of consent
    E.4Principal exclusion criteria
    Any potential study subject who meets any of the following criteria below will be excluded from participating in this study.
    The subject:
    1.Is intubated and requires invasive ventilation OR is likely to require invasive ventilation in the next 3 days
    2.Has received any investigational RSV vaccine after HSCT
    3.Has received any monoclonal anti-RSV antibodies within 4 months or 5
    half-lives before screening, whichever is longer
    4.Requires treatment (or is known to require treatment) with intravenous ribavirin prior to subject being randomised in the study
    5.Is documented to be positive for parainfluenza within 7 days before the screening visit
    6.Is documented to be positive for influenza on a sample collected from the nose or pharynx ≤2 days before Day 1
    7.Has clinically significant bacteraemia or fungaemia within 7 days before screening that has not been adequately treated
    8.Has clinically significant bacterial, fungal, or viral pneumonia (due to a virus other than RSV) within 2 weeks before screening that has not been adequately treated
    9.Is precluded from participating in this study as a result of treatment with another investigational drug or participation in another clinical trial
    10.If female, is pregnant, lactating or breast feeding
    11.Has any other disease or condition which in the Investigator's medical opinion would preclude the subject's participation in a clinical trial
    12.Is receiving an antiretroviral protease inhibitor
    13.Has chronic, active hepatitis infection
    14.Has any known history or current evidence of alcohol or drug abuse that, in the Investigator's opinion, would exclude the subject from participation in the study
    15.Is employed by or is a first-degree relative of anyone employed by Pulmocide, a participating clinical trial site or any contract research
    organisation involved in the study
    E.5 End points
    E.5.1Primary end point(s)
    •Slope of the RSV load over Days 1–3 measured in nasal secretions by reverse transcription quantitative polymerase chain reaction (RT-qPCR)
    •Safety will be assessed using:
    oAdverse events (AEs)
    oTwelve-lead electrocardiogram (ECGs)
    oVital signs
    oClinical laboratory evaluations (haematology, clinical chemistry, urinalysis)
    oPeak expiratory flow (PEF)
    oPhysical examination
    E.5.1.1Timepoint(s) of evaluation of this end point
    Nasal secretions (RT-qPCR) - Days 1, 2, 3,4,5,6,7,14 and 28
    AEs - continuous collecting (Screening to day 28)
    12-lead ECGs - Baseline, Day 1, 2, 3,7 and 28
    Vital signs - Baseline, Days 1, 2, 3,7 and 28
    Clinical laboratory evaluations - Days 1, 2, 3, 7 and 28
    PEF- Days 1, 2, 3, 7, 14 and 28
    Physical examination - Baseline, Days 2, 3,7,14 and 28
    E.5.2Secondary end point(s)
    •Additional anti-viral endpoints (to be determined by RT-qPCR on nasal
    secretions) will include:
    -Time-weighted average change in RSV load from Day 1 to Day 7 (DAVG7)
    -Change in RSV load from baseline (before first dose of PC786 or placebo) to Day 3
    -Change in RSV load from baseline (before first dose of PC786 or placebo) to Day 7
    -Duration of viral shedding
    •PC786 concentration (measured in nasal MLF)
    •PC786 pharmacokinetic parameters measured in plasma (e.g., area
    under the concentration versus time curve [AUC], trough plasma
    concentration [Ctrough] and maximum observed concentration [Cmax])
    •Effect of PC786 on RSV symptoms (assessed using a subject-reported
    symptom diary card)
    •Development of LRTI or pneumonia (due to RSV or secondary [bacterial
    or fungal] infection)
    •Progression to invasive ventilation
    •Trends on oxygen saturation index over Days 1–7
    E.5.2.1Timepoint(s) of evaluation of this end point
    Nasal secretions (RT-qPCR) - Days 1, 2, 3,4,5,6,7,14 and 28
    Nasal MLF PK analysis - Days 1, 2,3,7,14 and 28
    Blood for PK - Days 1,2,3, 7, 14 and 28
    LRTI assessment - Days 1, 2,3,7,14 and 28 (additional days if
    hospitalised - days 4,5, and 6)
    PEF - Days 1,2,3, 7, 14 and 28
    Symptom scores - Days 1,2,3,4,5,6,7, 14 and 28
    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 trial2
    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 concerned10
    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
    LVLS
    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 months5
    E.8.9.1In the Member State concerned days0
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 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 state30
    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 undergo a follow up visit at the end of the study and any ongoing adverse events will be followed until resolution. Subject's care is the responsibility of the subject's hospital doctor and GP following conclusion of the study.
    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 Decision2018-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-05-01
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