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    Summary
    EudraCT Number:2005-006179-11
    Sponsor's Protocol Code Number:TMC114-C212
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2006-04-20
    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 number2005-006179-11
    A.3Full title of the trial
    A Phase II, open-label trial, to investigate pharmacokinetics, safety, tolerability and antiviral activity of TMC114/rtv b.i.d. in treatment-experienced HIV-1 infected children and adolescents.
    A.4.1Sponsor's protocol code numberTMC114-C212
    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 nameTMC114 ethanolate
    D.3.2Product code TMC114
    D.3.4Pharmaceutical form Film-coated 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 INNdarunavir
    D.3.9.1CAS number 206361-99-1
    D.3.9.2Current sponsor codeTMC114 (F016)
    D.3.9.3Other descriptive nameTMC114 ethanolate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 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 nameTMC114 ethanolate
    D.3.2Product code TMC114
    D.3.4Pharmaceutical form Film-coated 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 INNdarunavir
    D.3.9.1CAS number 206361-99-1
    D.3.9.2Current sponsor codeTMC114 (F027)
    D.3.9.3Other descriptive nameTMC114 ethanolate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Norvir
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories 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.3.1Product nameNorvir
    D.3.4Pharmaceutical form Capsule, soft
    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 INNritonavir
    D.3.9.1CAS number 155213-67-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Norvir
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories 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.3.1Product nameNorvir
    D.3.4Pharmaceutical form Oral solution
    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 INNritonavir
    D.3.9.1CAS number 155213-67-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    HIV-1
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10020160
    E.1.2Term HIV disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    PART I OBJECTIVES

    The objectives are:
    - To evaluate the pharmacokinetic profile of two different doses of TMC114 in combination with low-dose ritonavir administered b.i.d. in the pediatric population at steady-state: AUC12h, Cmax and Cmin;
    - To provide dose recommendation of TMC114 per body weight in pediatric subjects of ≥ 20 kg to < 50 kg;
    - To evaluate short-term safety, tolerability and antiviral activity of two different doses of TMC114/rtv administered b.i.d. in treatment-experienced pediatric subjects.


    PART II PRIMARY OBJECTIVE

    - To evaluate long-term safety, tolerability and efficacy of TMC114 in combination with low-dose ritonavir administered b.i.d. and other ARV agents over a 24-week treatment period at the recommended pediatric (≥ 20 kg to < 50 kg) and adult (≥ 50 kg) doses.
    E.2.2Secondary objectives of the trial
    PART II SECONDARY OBJECTIVES

    - To evaluate long-term safety, tolerability and efficacy of TMC114 in combination with low-dose ritonavir administered b.i.d. and other ARV agents over a 48-week treatment period at the recommended pediatric (≥ 20 kg to < 50 kg) and adult (≥ 50 kg) doses;
    - To evaluate immunology, resistance characteristics, pharmacokinetic parameters and pharmacokinetic/pharmacodynamic (PD) relationships of TMC114/rtv over 48 weeks of treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects who meet all of the following criteria are eligible for this trial.

    1. Boys and girls, aged between 6 and 17 years.

    2. Subjects with documented HIV-1 infection.

    3. Body weight Part I: ≥ 20 to < 50 kg.
    Body weight Part II: ≥ 50 kg and from ≥ 20 to < 50 kg after pediatric dose selection.

    4. Being able to swallow the TMC114 tablet formulation(s) and the ritonavir capsule formulation, and to tolerate the ritonavir liquid formulation (liquid formulation only applicable for subjects < 40 kg).

    5. Stable CD4+ percentage: no more than 5% decrease in CD4+ percentage between the screening visit and the last available CD4+ measurement (with a minimum of 4 weeks and a maximum of 24 weeks between screening visit and last measurement).

    6. Subjects currently on a stable ART who need to change their ARV regimen because it is currently failing (at least 12 weeks on therapy), with a viral load of > 1000 copies/mL.

    7. Parents or legal representative and trial subjects (where appropriate, depending on age and local regulation) willing and able to give consent. Children will be informed about the trial and asked to give positive assent as per description in Chapter II, section 6.4

    8. Subjects can comply with the protocol requirements.

    9. General medical condition, in the investigator’s opinion, does not interfere with the assessments and the completion of the trial.

    10. Female subjects who are sexually active and able to become pregnant must use a safe and effective birth control method, such as medically accepted barrier methods of contraception (e.g., diaphragm, and condom) during the study. Hormonal birth control alone would not be considered adequate, as the interaction between study drug and hormonal birth control is not available.
    E.4Principal exclusion criteria
    Subjects meeting one or more of the following criteria cannot be selected:

    1. Part I: Use of the NNRTI efavirenz as part of the current regimen is not allowed.
    Part II: Use of efavirenz as part of the current regimen is allowed (see Table 2).

    2. Presence of any currently active AIDS defining illness [Category C conditions according to the CDC Classification System for HIV Infection 1993 or according to the 1994 revised CDC Classification System for HIV infection in children less than 13 years of age (see Addendum 6; Section 7.6)]:
    Note: An AIDS defining illness not clinically stabilized for at least 30 days will be
    considered as currently active.
    Note: Primary and secondary prophylaxis for an AIDS defining illness is allowed in
    cases where the medication administered is not part of the disallowed
    medications (see Section 5.5.12).

    3. Active substance use as determined by the investigator during anamnesis that includes but is not limited to daily or frequent alcohol intake, use of solvents,
    barbiturate, amphetamine, and recreational or narcotic drugs.
    Note: Prescribed use of methadone is allowed (see Table 2).

    4. Use of disallowed concomitant therapy (see Section 5.5.12).

    5. Use of any antiretroviral and non-antiretroviral investigational agents within 30 days prior to screening, except for tenofovir, tipranavir, atazanavir and fosamprenavir.
    Note: TMC114 should not be used within 14 days following the use of tipranavir.
    A minimal 14-day washout period is required in which tipranavir must be either
    interrupted or substituted to an investigator selected PI regimen until the
    baseline visit (Day 1).

    6. Life expectancy of less than 6 months.

    7. Co-enrollment in other clinical and/or cohort trials without written permission of the sponsor.

    8. Pregnancy or breastfeeding.

    9. Any active clinically significant disease (e.g., TB, cardiac dysfunction, pancreatitis, acute viral infections) or findings during screening of medical history or physical examination that, in the investigator’s opinion, would compromise the subject’s safety or outcome of the trial.

    10. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC114) or ritonavir.
    Note: TMC114 is a sulfonamide. Subjects who previously experienced a
    sulfonamide allergy will be allowed to enter the trial. To date, no potential for
    cross sensitivity between drugs in the sulfonamide class and TMC114 has been
    identified in subjects participating in phase II trials.

    11. Subjects with documented hepatic impairment.
    Note: subjects co-infected with chronic hepatitis B or C (determined by hepatitis B
    surface antigen, anti core-hepatitis B IgG antibody and hepatitis C antibody) will
    be allowed to enter the trial if their condition is clinically stable, and they are not
    expected to require treatment during the study period and have ALT or AST levels
    < 3 x ULN. Subjects diagnosed with acute viral hepatitis at screening will not be
    allowed in the trial (e.g., hepatitis A IgM antibody).

    12. Subjects with the following laboratory abnormalities as defined by the DAIDS grading scheme:
    · any grade 3 or 4 toxicity with the following exceptions unless clinical assessment
    foresees an immediate health risk to the subject:
    - subjects with pre-existing diabetes or asymptomatic glucose elevations of
    grade 3 or grade 4
    - subjects with asymptomatic triglyceride or cholesterol elevations of grade 3 or
    4
    E.5 End points
    E.5.1Primary end point(s)
    FOR PART I

    The primary efficacy parameter will be virologic response at Week 2, defined as a drop in viral load (copies/mL) of at least 0.5 log10 versus baseline. The main analysis will be a non-completing = failure analysis (NC=F); i.e. all subjects who have discontinued the trial prematurely will be considered as failures.


    FOR PART II

    The primary efficacy parameter will be confirmed virologic response (TLOVR) at Week 24, defined as a drop in viral load (copies/mL) of at least 1 log 10 versus baseline.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability / Dose recommendation in pediatric subjects / Immunology
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Minors
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 80
    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)
    Tibotec will provide follow-up treatment with TMC114 for all subjects who continue to benefit from treatment with TMC114 after the end of the trial.
    TMC114 will be provided until the formulation for paediatric patients is commercially available or until its development is discontinued.
    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 Decision2006-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-14
    P. End of Trial
    P.End of Trial StatusOngoing
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