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    The EU Clinical Trials Register currently displays   36083   clinical trials with a EudraCT protocol, of which   5932   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-003439-53
    Sponsor's Protocol Code Number:TMC353121-TiDP19-C202
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-09-14
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2006-003439-53
    A.3Full title of the trial
    A double blind, randomized, placebo-controlled study to evaluate the antiviral activity, safety and plasma pharmacokinetics of multiple intravenous doses of TMC353121 in hematopoietic stem cell transplant subjects (autologous and allogeneic) with evidence of upper respiratory tract infection (URTI) caused by the respiratory syncytial virus (RSV)
    A.4.1Sponsor's protocol code numberTMC353121-TiDP19-C202
    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 SponsorTibotec Pharmaceuticals Ltd
    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 nameTMC353121
    D.3.2Product code R391036 or JNJ-27387581-AAA, formulation F002
    D.3.4Pharmaceutical form Solution for infusion
    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 INNN.A
    D.3.9.1CAS number N.A
    D.3.9.2Current sponsor codeTMC353121 (R391036)
    D.3.9.3Other descriptive nameJNJ-27387581-AAA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 placeboSolution for infusion
    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
    Respiratory Synctycial Virus (RSV)
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the trial is to estimate the antiviral activity and safety of a 7-day dosing regimen with 0.5 mg/kg/2h/day of TMC353121 in RSV infected post-stem cell transplant subjects having URTI.
    E.2.2Secondary objectives of the trial
    - To evaluate safety parameters of both local and systemic toxicity.
    - To evaluate severity of clinical signs of URTI (such as rhinitis with nasal discharge,
    rhinitis with nasal obstruction, sore throat, laryngitis, pharyngitis, otitis media, sinusitis) and LRTI (wheezing, dyspnea, increased sputum production, increased respiratory rate, pulmonary infiltration, fever) over time.
    - To evaluate progression of URTI to LRTI: 28-day mortality incidence, morbidity, days
    of hospitalization, days in ICU, length of O2 therapy, lung function (spirometry) and
    chest X ray.
    - To document the plasma concentration profile of multiple intravenous doses of
    TMC353121 on Days 7 to 9, and to assess the time to reach steady-state plasma levels.
    - To evaluate the general health condition including cGVHD and Karnofsky performance status.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject in post-engraftment status of autologous or allogeneic transplantation, with URTI, with nasopharyngeal washings/aspirates positive for RSV, diagnosed locally. Diagnosis of URTI will be considered when in the absence of LRTI diagnosis, at least 1 of the following symptoms is present: rhinitis with nasal discharge, rhinitis with nasal obstruction, sore throat, laryngitis, pharyngitis, otitis media, sinusitis. Diagnosis of LRTI will be considered when at least 1 of the following symptoms is present: wheezing, dyspnea, increased sputum production, increased respiratory rate, pulmonary infiltration (based on chest X-ray, at the discretion of the investigator), fever (in the presence of at least 1 other LRTI related
    symptom).
    2. Subject between 18 and 65 years, extremes included.
    3. Informed Consent Form signed voluntarily.
    4. Subject agrees to use a reliable double barrier birth control method for the duration of the study.
    E.4Principal exclusion criteria
    1. Subject receiving any drug treatment for RSV, such as but not limited to ribavirin, Synagis, Respigam, Numax.
    2. Subject with severe acute or chronic graft versus host reaction (GVHR).
    3. History of bleeding disorder within the last 5 years.
    4. Subject with pathologically prolonged QTc value at study entry
    5. Subject with grade 3 or 4 toxicity, as defined by the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table. At the discretion of the investigator, subjects with confirmed stable grade 3 toxicity and grade 3 hematological
    toxicity may be included. Because of the presence of hydroxypropyl-beta-cyclodextrin in the TMC353121 formulation, patients with moderate to severe renal impairment should not be enrolled (creatinine clearance < 50 mL/min).
    6. Pregnant or breast-feeding woman.
    7. Subject with pneumonia or requiring a ventilator to breathe, at entry.
    8. Subject participating in another clinical trial with an experimental drug, up to 30 days prior to enrolment in this study.
    9. Karnofsky performance status < 70%.
    10. Patients receiving treatment with itraconazole
    E.5 End points
    E.5.1Primary end point(s)
    - estimation of the antiviral activity and safety of TMC353121
    - measurement of levels of TMC353121 in plasma for evaluation of PK parameters
    - evaluation of nasopharyngeal washings + aspirates for resitance testing
    - measurement of RSV viral titer in nasopharyngeal washings + aspirates
    - immunologic value and change, measured by RSV-IgA
    - adverse events inquiry, vital signs, 12-lead ECG, lung function testing (spirometry, peak expiratory flow, peripheral O2 saturation), performance status, hematology and coagulation, biochemistry, urinalysis
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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
    tolerability
    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 No
    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.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    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 months8
    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 months8
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    N.A
    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 Decision2006-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-08
    P. End of Trial
    P.End of Trial StatusCompleted
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