Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35513   clinical trials with a EudraCT protocol, of which   5839   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2009-010887-41
    Sponsor's Protocol Code Number:TMC125-TiDP2-C238
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-04-15
    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 ConcernedFrance - ANSM
    A.2EudraCT number2009-010887-41
    A.3Full title of the trial
    A randomized, exploratory, open-label 48-week trial with a 2-week Pre-Treatment Phase to investigate the pharmacokinetics, safety, tolerability and antiviral activity of etravirine (ETR) in combination with ritonavir-boosted atazanavir (ATV/rtv) and 1 NRTI in treatment-experienced HIV-1 infected subjects
    A.4.1Sponsor's protocol code numberTMC125-TiDP2-C238
    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
    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 Yes
    D.2.1.1.1Trade name Intelence 100 mg tablets
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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 nameetravirine (ETR, TMC125)
    D.3.2Product code TMC125 (R165335) F060
    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 INNetravirine
    D.3.9.1CAS number 269055-15-4
    D.3.9.2Current sponsor codeETR
    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: 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 Reyataz
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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 nameAtazanavir
    D.3.4Pharmaceutical form Capsule, hard
    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 INNAtazanavir sulphate
    D.3.9.2Current sponsor codeATV
    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 Reyataz
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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 nameAtazanavir
    D.3.4Pharmaceutical form Capsule, hard
    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 INNAtazanavir sulphate
    D.3.9.2Current sponsor codeATV
    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: 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 Viread
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International 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 nameTenofovir disoproxil fumarate
    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 INNTenofovir disoproxil fumarate
    D.3.9.2Current sponsor codeTDF
    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.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 infection
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020192
    E.1.2Term HIV-1
    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 pharmacokinetic interaction between ETR and ATV/rtv at 2 different doses
    E.2.2Secondary objectives of the trial
    •to assess the impact of cytochrome P450 (CYP) 2C9 and 2C19 genotypes on ETR
    pharmacokinetics;
    • to evaluate safety and tolerability of ETR in combination with ATV/rtv and 1 NRTI over
    48 weeks;
    • to evaluate the antiviral activity of ETR in combination with ATV/rtv and 1 NRTI over
    48 Weeks;
    • to evaluate the immunologic changes (as measured by CD4 cells) with ETR and ATV/rtv
    with 1 NRTI over 48 weeks;
    • to evaluate changes in viral genotype and drug susceptibility over 48 weeks.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The substudy is included in the protocol final version dated 10 March 2009.

    The objectives of the substudy are:
    • to evaluate the pharmacokinetics of ETR, ATV, and ritonavir with and without coadministrtation of TDF;
    • to evaluate short-term safety and tolerability of ETR + ATV/rtv + 1 investigator-selected NRTI + TDF.
    E.3Principal inclusion criteria
    1. Male or female subjects, aged 18 years or above.
    2. Subject has signed the informed consent form (ICF) voluntarily.
    3. Subject can comply with the protocol requirements.
    4. Subject with documented HIV-1 infection.
    5. HIV-1 plasma viral load at Screening Visit above 500 HIV-1 RNA copies/mL.
    6. Subject has received at least one HAART regimen
    Note: HAART is defined as potent anti-HIV treatment usually including a combination
    of 3 or more drugs with activity against HIV whose purpose is to reduce viral load to
    undetectable. This regimen usually includes treatment with at least 2 NRTIs in
    combination with at least 1 additional ARV from the NNRTI and/or PI class.
    Note: Subjects on a structured treatment interruption for a minimum of 4 weeks at the time of screening are allowed.
    7. On a stable antiretroviral therapy (ART) for at least 8 weeks at Screening and willing to stay on that treatment until the start of the Pre-Treatment Phase.
    8. Presence of at least 1 of the following mutations (based upon the following list of
    47 NNRTI RAMs: V90I, A98G, L100I, K101E/H/P/Q, K103H/N/S/T, V106A/I/M,
    V108I, E138A/G/K/Q, V179D/E/F/G/I/T, Y181C/I/V, Y188C/H/L, V189I,
    G190A/C/E/Q/S, H221Y, P225H, F227C/L, M230I/L, P236L, K238N/T, Y318F) on the
    resistance test at Screening or from prior genotypic analysis, evidence of which should be available in the source documents and enrollment of the subject based on these data needs to be agreed upon by the sponsor.
    9. Demonstrated sensitivity to ATV, ETR and at least one of the selected NRTIs based on the resistance test at Screening.
    10.General medical condition, in the investigator’s opinion, does not interfere with the assessments and completion of the trial.
    Subjects who meet all of the criteria above and the following criteria are eligible for the
    substudy:
    1. Currently enrolled in trial TMC125-C238 for > 24 weeks.
    2. Informed Consent Form (ICF) signed voluntarily.
    3. HIV-1 plasma viral load < 50 copies/mL on at least the 2 most recent consecutive visits.
    4. General medical condition, in the investigator’s opinion, does not interfere with the
    assessments and completion of the substudy.
    E.4Principal exclusion criteria
    1. Primary HIV-1 infection.
    2. Previously documented HIV-2 infection.
    3. Previously failed 2 or more HIV PI-containing regimens.
    4. Use of disallowed concomitant therapy.
    5. Previous diagnosis of hereditary hyperbilirubinemia (eg. Gilbert’s syndrome, Crigler- Najjar syndrome).
    6. Any condition (including but not limited to alcohol and drug use) which, in the opinion of the investigator, could compromise the subject’s safety or adherence to the protocol.
    7. Life expectancy less than 6 months according to the judgment of the investigator.
    8. Subject has any currently active AIDS defining illness with the following exceptions, which must be discussed with the sponsor prior to enrollment:
    a. Stable cutaneous Kaposi’s Sarcoma (i.e., no pulmonary or gastrointestinal
    involvement other than oral lesions) that is unlikely to require any form of
    systemic therapy during the trial period.
    b. Wasting syndrome due to HIV infection if, in the investigator’s opinion, it is not
    actively progressive and its treatment does not require hospitalization or
    compromise the subject’s safety or compliance to adhere to trial related
    procedures.
    Note: An AIDS defining illness not clinically stabilized for at least 30 days will be
    considered clinically active. Primary and secondary prophylaxis for an AIDS defining
    illness is allowed in case the medication used is not part of the disallowed medication.
    9. Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction) or
    findings during screening of medical history, laboratory or physical examination that, in the investigator’s opinion, would compromise the subject’s safety or outcome of the trial.
    10. Acute viral hepatitis including but not limited to A, B, or C.
    11. Chronic hepatitis B and/or C co-infection.
    12. Receipt of an investigational drug or investigational vaccine within 30 days prior to the trial drug administration.
    13. Previously demonstrated clinically significant allergy or hypersensitivity to ETR or to any of the excipients of ETR.
    14. Pregnant or breastfeeding female subject.
    15. Female subject of childbearing potential not using effective birth control methods or not willing to continue practicing these birth control methods during the trial and for at least 30 days after the end of the trial (or after last intake of investigational medication;
    Note: Hormone-based contraception may not be reliable when taking ARV agents;
    therefore, to be eligible for this trial, women of childbearing potential should either:
    • use a double barrier method to prevent pregnancy (i.e., using a male condom with
    diaphragm or cervical cap); or
    • use an hormonal contraceptive in combination with a barrier contraceptive (i.e.,
    female/male condom, diaphragm or cervical cap); or
    • use an intrauterine device (IUD) in combination with a barrier contraceptive (i.e.,
    female/male condom, diaphragm or cervical cap); or
    • do not engage in heterosexual sex, or have a vasectomized partner with confirmed
    sterility.
    Note: Women who are postmenopausal for at least 2 years and women with surgical
    sterilization, i.e., tubal ligation or total hysterectomy, are considered of non-childbearing
    potential.
    Note: Spermicides contain non-oxynol-9 and should not be used as this can potentially
    increase the rate of HIV-1 transmission.
    Note: Use of an IUD can increase the risk of sexually transmitted infections, including
    HIV.
    16. Non-vasectomized heterosexually active male subject not using effective birth control methods or not willing to continue practicing these birth control methods during the trial and until 30 days after the end of the trial (or after last intake of investigational medication.
    17. Any grade 3 or 4 laboratory abnormalities in aspartate aminotransferase (AST), alanine aminotransferase (ALT), amylase, lipase, hemoglobin or neutrophils.
    Note: Retesting of abnormal screening values that lead to exclusion will be allowed only once using an unscheduled visit during the Screening Period (to reassess eligibility).
    18. Subjects who previously received treatment with either ETR (TMC125), dapivirine
    (TMC120), or rilpivirine (TMC278).
    Subjects meeting one or more of the following criteria cannot be selected for the substudy:
    1. Previously demonstrated clinically significant allergy or hypersensitivity to TDF or to any of the excipients of TDF.
    2. Any grade 3 or 4 serum creatinine abnormalities or a calculated creatinine clearance (CLcr) < 50 mL/min.
    E.5 End points
    E.5.1Primary end point(s)
    The first analysis will be performed when all subject have been treated with ETR for 12 weeks or discontinued earlier. The purpose of this analysis is mainly to evaluate the pharmacokinetics, safety, and short-term antiviral responses.
    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 No
    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, antiviral activity, immunological changes, viral genotype changes
    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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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) Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 46
    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)
    After the 48-week Treatment Phase, subjects receiving and expected to continue receiving clinical benefit from ETR can switch to commercial ETR if available. If commercial ETR is not available, ETR will be provided by the sponsor until the subject no longer benefits from ETR or until ETR is available via the local healthcare system to the participating subject in his/her country.
    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 Decision2009-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-22
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA