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    Summary
    EudraCT Number:2009-012848-16
    Sponsor's Protocol Code Number:A1501085
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-08-17
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2009-012848-16
    A.3Full title of the trial
    A PROSPECTIVE, OPEN-LABEL, NON-COMPARATIVE STUDY TO ASSESS THE SAFETY, TOLERABILITY AND EFFICACY OF VORICONAZOLE FOR THE PRIMARY AND SALVAGE TREATMENT OF INVASIVE CANDIDIASIS, CANDIDEMIA, AND ESOPHAGEAL CANDIDIASIS IN PEDIATRIC SUBJECTS
    A.4.1Sponsor's protocol code numberA1501085
    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 SponsorPfizer Inc., 235 East 42nd Street, New York, NY 10017
    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 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 Yes
    D.2.1.1.1Trade name Vfend
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVoriconazole
    D.3.9.3Other descriptive name(2R, 3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Vfend
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVoriconazole
    D.3.9.3Other descriptive name(2R, 3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Vfend
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Powder for 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 INNVoriconazole
    D.3.9.3Other descriptive name(2R, 3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 4
    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 Yes
    D.2.1.1.1Trade name Vfend
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVoriconazole
    D.3.9.3Other descriptive name(2R, 3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Invasive candidiasis, including candidemia (ICC), and esophageal candidiasis (EC)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10007161
    E.1.2Term Candidiasis of the esophagus
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10060573
    E.1.2Term Candidemia
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10064954
    E.1.2Term Invasive candidiasis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of voriconazole for the treatment of invasive candidiasis, including candidemia, and esophageal candidiasis in pediatric subjects 2 to <18 years of age.
    E.2.2Secondary objectives of the trial
     To assess the efficacy of voriconazole for the treatment of invasive candidiasis, including candidemia, and esophageal candidiasis in pediatric subjects 2 to <18 years of age.
     To assess time to death and all-cause mortality during study therapy, at Day 28, and at the one month follow-up visit.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male or female 2 to<18 yrs of age;
    •A personally signed and dated informed consent document indicating that a legally authorized representative has been informed of all pertinent aspects of the study. Assent will be required for children per local regulations or/and for those who are able to comprehend;
    •Willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures;
    •A diagnosis of invasive candidiasis/candidemia (ICC) or esophageal candidiasis(EC);
    •Therapy with voriconazole must be considered an appropriate treatment option by the investigator.
    Primary ICC: the following two criteria must be met:
    1. Must have at least one of the following:
    •At least one positive blood culture or culture from a normally sterile site for yeast (later confirmed as Candida sp.) or for Candida sp. within the previous 7 days prior to the first dose of study medication; or
    •Histopathologic/direct microscopic evidence suggestive of Candida sp. (later confirmed as Candida sp.) from at least one specimen obtained from a normally sterile site within the previous 7 days prior to the first dose of study medication; or
    •At least one positive culture for yeast (later confirmed as Candida sp.) or Candida sp. from a drain placed <24 hours within the previous 7 days prior to the first dose of study medication; or
    •New radiologic findings consistent with disseminated disease after a positive culture for Candida sp. within the previous 14 days prior to enrollment.
    2. Must have at least one of the following:
    •Fever (oral or tympanic or axillary) temperature ≥38.0°C (100.4°F)); or
    •Hypothermia (temperature <36.0°C (96.8°F)); or
    •SBP less than 100 mmHg,or a decrease in SBP of at least 30 mmHg from baseline; or
    •Site specific signs and symptoms of Candida infection; or
    •Radiologic findings consistent with Candida infection.
    Salvage ICC: the following two criteria are met:
    1. Must have at least one of the following:
    •At least one positive blood culture or culture from a normally sterile site for yeast (later confirmed as Candida sp.) or for Candida sp. within the previous 14 days prior to the first dose of study medication; or
    •Histopathologic/direct microscopic evidence suggestive of Candida sp. (later confirmed as Candida sp.) from at least one specimen obtained from a normally sterile site within the previous 14 days prior to prior to the first dose of study medication; or
    •At least one positive culture for yeast (later confirmed as Candida sp.) or for Candida sp. from a drain placed <24 hours, within the previous 14 days prior to the first dose of study medication; or
    •New radiologic findings consistent with disseminated disease after a positive culture for Candida sp. within the previous 14 days prior to enrollment.
    2. Must have had a clinical and/or microbiologic response deemed as unsatisfactory to at least one other antifungal after at least 7 days of therapy at clinically recognized effective doses.
    Primary EC: all of the following three criteria must be met:
    •Must have clinical symptoms consistent with esophageal candidiasis, such as dysphagia, odynophagia and retrosternal pain, with or without concomitant oropharyngeal candidiasis withing the previous 7 days prior to enrollment.
    •Must have lesions characteristic of esophageal candidiasis visualized by esophagoscopy within the previous 7 days prior to enrollment.
    •Must have positive microscopy and/or mycological culture for yeast (later confirmed as Candida sp.) or Candida sp. from a brush biopsy or tissue biopsy of esophageal lesions within the previous 7 days prior to enrollment. (In subjects with neutropenia, thrombocytopenia or advanced HIV/AIDS, esophagoscopy and/or culture confirmation is not required if the risks associated with performing an esophagoscopy or obtaining a tissue specimen for culture outweigh the benefits.)
    Salvage EC: all of the following two criteria are met:
    •Must have clinical symptoms consistent with esophageal candidiasis, such as dysphagia, odynophagia and retrosternal pain, with or without concomitant oropharyngeal candidiasis withing the previous 14 days prior to enrollment.
    •Must have lesions characteristic of esophageal candidiasis visualized by esophagoscopy within the previous 14 days prior to enrollment.
    •Must have positive microscopy and/or mycological culture for yeast (later confirmed as Candida sp.) or Candida sp. from a brush biopsy or tissue biopsy of esophageal lesions within the previous 14 days prior to enrollment. (In subjects with neutropenia, thrombocytopenia or advanced HIV/AIDS, esophagoscopy and/or culture confirmation is not required if the risks associated with performing an esophagoscopy or obtaining a tissue specimen for culture outweigh the benefits.)
    Must have had a clinical and/or microbiologic response deemed as unsatisfactory to at least one other antifungal after at least 7 days of therapy at clinically recognized effective doses.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following exclusions will not be included in the study:
    1. Known allergy, serious reaction, or hypersensitivity to voriconazole or its excipients, or any azole antifungal agent.
    2. Females who are pregnant, lactating (breast feeding) or planning a pregnancy during the course of the study, or who are of childbearing potential and not using highly effective method of birth control (eg, surgically sterile, intrauterine device, oral contraceptive plus barrier contraceptive, hormone delivery system plus barrier contraceptive, or condom in combination with contraceptive cream, jelly, or foam).
    Subjects are to continue contraceptive methods during the study and for at least 30 days after receiving their last treatment.
    3. Subjects receiving, or are likely to receive, any Phase I investigational drug. (Note: Subjects receiving Phase II or III investigational drugs may be enrolled only with the prior approval of the Sponsor's medical monitor. Subjects receiving investigational drugs that are currently licensed for other indications may be enrolled).
    4. Subjects who have received drugs that may cause QT interval prolongation within 24 hours prior to enrollment. Including, but not limited to, the following: terfenadine, astemizole, cisapride, pimozide, or quinidine.
    5. Requiring continued treatment with another systemic antifungal agent.
    6. Concomitantly receiving one of the following drugs: sirolimus, rifampin, rifabutin, carbamazepine, long-acting barbiturates (eg, phenobarbital, mephobarbital), ritonavir, efavirenz, or ergot alkaloids (eg, ergotamine, dihydroergotamine).
    7. Concomitantly receiving drugs with clinically relevant drug interactions with voriconazole, unless closely monitored or dosage adjusted as clarified in Appendix 1.
    8. Poor venous access or other considerations that would preclude intravenous drug delivery or blood sampling.
    9. For Primary Therapy: Subjects who have received more than 48 hours antifungal
    therapy (prior to the first dose of study drug) for the treatment of an active fungal infection. ** Please note ** Subjects receiving antifungal agents for the prophylaxis (eg, for the prevention of fungal infection) prior to and up to the time of enrollment are eligible to participate in the study.
    10. Liver dysfunction, at baseline, defined as total bilirubin, AST, ALT, or alkaline phosphatase >5 times the upper limit of normal. Note: If laboratory values drawn at the screening visit (prior to the first dose of study medication) exceeds the above limits for exclusion, the Sponsor's medical monitor must be contacted without delay to discuss enrollment and initiation of study treatment.
    11. Subjects with moderate or severe renal impairment (creatinine clearance <50 mL/min), unless an assessment of the benefit/risk to the subject justifies the use of intravenous voriconazole. A subject with moderate or severe renal impairment may be enrolled only with prior approval of the Sponsor's medical monitor.
     Creatinine Clearance will be calculated using the Schwartz formula.
     Creatinine Clearance (mL/min) = [k x height (cm)]/serum creatinine (mg/dL).
    Where k = 0.55 for either gender ≤12 years of age; k =0.55 for females 13 to 21 years of age; and k = 0.7 for males 13 to 21 years of age. Note: Other methods of calculation creatinine clearance (eg, 24-hr urine creatinine collection) are permissible.
    12. Subjects with prosthetic devices and/or vascular catheters (eg, central venous catheter, implanted port) at a suspected site of infection are to be excluded, unless the device/catheter is removed at study entry or soon after randomization (within 24 – 48 hrs). Note: In the event prosthetic devices or vascular catheters cannot be removed within this time frame, the Sponsor's medical monitor must be contacted to discuss enrollment and initiation of study treatment.
    13. Subjects with a prosthetic heart valve or vascular graft suspected to be the site of the Candida infection and positive blood cultures.
    14. At the discretion of the investigator, any condition including psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of the study results and would make the subject inappropriate for entry into this study. Examples include sever liver dysfunction, severe renal impairment, or known ECG abnormalities or arrhythmias.
    15. Subjects with a high likelihood of death within 72 hours of enrollment due to factors unrelated to the current episode of Candida infection.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability of voriconazole, as determined by the rate of adverse events (serious and non-serious), including visual-, cardiac-, and liver-related adverse effects, and treatment discontinuation.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 EEA45
    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
    As per protocol
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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.1.1.1In 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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    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 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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 39
    F.4.2.2In the whole clinical trial 96
    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)
    As per Protocol
    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 Decision2010-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-07
    P. End of Trial
    P.End of Trial StatusOngoing
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