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    The EU Clinical Trials Register currently displays   43931   clinical trials with a EudraCT protocol, of which   7307   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).

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    Summary
    EudraCT Number:2010-021628-84
    Sponsor's Protocol Code Number:VX-950-C211
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-10-11
    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 ConcernedSweden - MPA
    A.2EudraCT number2010-021628-84
    A.3Full title of the trial
    A randomized, open-label, Phase 3 study of telaprevir administered twice daily or every 8 hours in combination with pegylated interferon alfa-2a and ribavirin in treatment-naïve subjects with genotype 1 chronic hepatitis C virus infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare two dosing schedules (every 8 hours versus twice daily) for telaprevir when combined with pegylated interferon alfa-2a, ribavirin and hepatitis C virus genotype 1 in patients with HCV-1 who were never treated before.
    A.4.1Sponsor's protocol code numberVX-950-C211
    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 SponsorJanssen Infectious Diseases BVBA
    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 supportJanssen Infectious Diseases BVBA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV - Clinical Registry
    B.5.2Functional name of contact pointJanssen Biologics BV
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31 71 524 21 66
    B.5.5Fax number+31 71 524 21 10
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 nameTelaprevir
    D.3.2Product code VX-950
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNtelaprevir
    D.3.9.1CAS number 402957-28-2
    D.3.9.2Current sponsor codeVX-950
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number375
    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.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 Copegus®
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCopegus®
    D.3.2Product code J05A B04
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNRIBAVIRIN
    D.3.9.1CAS number 36791-04-5
    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) 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.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 Pegasys
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited, UK
    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 namePegasys®
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEGINTERFERON ALFA 2A
    D.3.9.1CAS number 198153-51-4
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number360
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Hepatitis C Virus (HCV)
    E.1.1.1Medical condition in easily understood language
    Chronic inflammation of the liver caused by hepatitis C virus infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10019752
    E.1.2Term Hepatitis C virus (HCV)
    E.1.2System Organ Class 10022891 - Investigations
    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 is to demonstrate the non-inferiority in sustained viral response (SVR12planned) of telaprevir administered as 1125 mg twice daily (b.i.d.) versus 750 mg every 8 hours (q8h) in combination with pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in treatment-naïve subjects with chronic HCV genotype 1 infection. SVR12planned is defined as having plasma HCV ribonucleic acid (RNA) levels < 25 IU/mL 12 weeks after the last planned dose of study drugs.
    E.2.2Secondary objectives of the trial
    • to evaluate tolerability and safety of telaprevir when administered as 750 mg q8h or 1125 mg b.i.d. in combination with Peg-IFN-alfa-2a and RBV;
    • to investigate the effect of IL28B genotype on viral response;
    • to evaluate pharmacokinetics of telaprevir, Peg-IFN-alfa-2a, and RBV and pharmacokinetic-pharmacodynamic relationships for safety and efficacy;
    • to evaluate changes from baseline in the amino acid sequence of the HCV NS3-4A region.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: A substudy to investigate telaprevir-related rash in a selected number of subjects enrolled in Study VX-950-C211
    Date: 14 September 2010
    Vesion: not applicable
    Objectives:
    · to explore a hypothesis regarding the mechanism of telaprevirassociated rash, i.e., telaprevir-associated rash is not typical (in frequency or pattern) for an immunologic reaction to a drug (or metabolite);
    · to further characterize mild (grade 1) or moderate (grade 2) telaprevirassociated
    rash, including likelihood of progression to severe rash.
    E.3Principal inclusion criteria
    -Subject is a man or a woman between 18 and 70 years of age, inclusive.
    -Subject has chronic HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL.
    Genotype must be confirmed during screening. Chronic infection status must be confirmed by detectable HCV RNA more than 6 months before the screening visit or by histological diagnosis of chronic hepatitis based on the liver biopsy.
    - Subjects should not have had any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C.
    - Subject is judged to be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening.
    - Subject must have documentation of a liver biopsy within 2 years before the screening visit or the subject must agree to have a biopsy performed within the screening period. If a biopsy more than 2 years prior to screening has already demonstrated histological cirrhosis, the biopsy does not need to be repeated if the biopsy report can be provided.
    - Subjects with cirrhosis should have serum alpha-fetoprotein (AFP) ≤ 50 ng/mL and normal abdominal ultrasound. If AFP > 50 ng/mL or ultrasound abnormal, absence of a mass must be demonstrated by a computed tomography (CT) scan or magnetic resonance imaging (MRI) scan. If a subject was screened for hepatocellular carcinoma within 5 months of the screening visit, this screening (ultrasound, CT, MRI) can be used to fulfill the inclusion criterion.
    - If heterosexually active, a female subject of childbearing potential and a nonvasectomized male subject who has a female partner of childbearing potential must agree to the use of 2 effective methods of contraception from screening onwards until 6 months (female subject) or 7 months (male subject) after the last dose of RBV.
    Note: Hormonal contraceptives may not be reliable when taking telaprevir. Therefore, to be eligible for this study, subjects should use 2 other effective birth control methods during telaprevir treatment and for 2 months after the last intake of telaprevir.
    - Subject or female partner is not pregnant, planning to become pregnant, or breastfeeding.
    All female subjects must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening.
    - Subject is willing/able to adhere to the prohibitions and restrictions specified in this protocol.
    - Subject must have signed an Informed Consent Form (ICF) including consent to IL28B testing, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
    - Subjects should agree not to participate in other clinical studies for the duration of their participation in this study, except for noninterventional or observational studies and only after prior approval of the sponsor.
    E.4Principal exclusion criteria
    Subject:
    - is infected or co-infected with HCV of another genotype than genotype 1.
    - presents a contraindication to the administration of Peg-IFN-alfa-2a or RBV, including but not limited to any of the following:
    •hypersensitivity to Peg-IFN-alfa-2a, RBV, or any of their components;
    •hemoglobinopathies (including thalassemia major, sickle-cell disease);
    •history or clinical evidence of significant cardiac disease and/or clinically significant ECG abnormalities;
    •abnormal thyroid function that is not adequately controlled;
    •poorly controlled diabetes mellitus as evidenced by hemoglobin A1c (HbA1c) ≥ 8.5% at screening;
    •creatinine clearance < 50 mL/min at screening;
    •antinuclear antibody (ANA) titer ≥ 1:640 at screening or other evidence of autoimmune-mediated disease
    - has known allergies, hypersensitivity, or intolerance to telaprevir or its excipients.
    - uses disallowed therapies.
    - has a pre-existing psychiatric condition, including but not limited to:
    •severe depression or hospitalization for depression;
    •schizophrenia, bipolar illness, severe anxiety, or personality disorder;
    •a period of disability or impairment due to a psychiatric disease within the past 5 years.
    - has history of decompensated liver disease: history of ascites, hepatic encephalopathy, or bleeding esophageal varices, and/or any of the
    following screening laboratory results:
    •International Normalized Ratio (INR) of ≥ 1.5;
    •Serum albumin < 3.3 g/dL;
    •Serum total bilirubin > 1.8 times upper limit of laboratory normal range (ULN), unless isolated or in subjects with Gilbert's Syndrome.
    - shows evidence of significant liver disease in addition to hepatitis C, which may include but is not limited to drug- or alcohol-related cirrhosis,
    autoimmune hepatitis, hemochromatosis, Wilson's disease, Nonalcoholic Steatohepatitis
    (NASH), or primary biliary cirrhosis.
    - has active malignant disease or history of malignant disease within the past 5 years.
    - has history of seizure disorders
    - has congenital or acquired prolonged QT interval, a history of nonsustained or sustained ventricular tachycardia, or a history of druginduced QT prolongation and/or Torsade de Pointes.
    - has history of organ transplant that requires chronic immunosuppression. Note: corneal, skin, and hair grafts are allowed.
    - has a medical condition that requires chronic or intermittent use of systemic corticosteroids (e.g., severe asthma, severe arthritis, or autoimmune conditions, organ transplantation, adrenal insufficiency, etc.).
    - has history or other evidence of clinically significant retinopathy or ophthalmological disorder, including but not limited to disorders due to diabetes mellitus or hypertension. Clearance by an ophthalmologist or a similarly qualified healthcare provider (e.g., an optometrist) is required within 3 months prior to screening or within the screening period for all subjects with diabetes mellitus, hypertension, or known retinal disorders. The ophthalmologist or similarly qualified healthcare provider should conduct a fundoscopic exam, which should be documented in the subjects' records. The findings of the exam must also be recorded on the electronic Case Report Form (eCRF).
    - has clinical evidence of chronic pulmonary disease associated with functional impairment.
    - has evidence of hemophilia or other bleeding disorder.
    - has evidence of serious or severe bacterial or fungal infection(s), including active tuberculosis.
    - has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) coinfection.
    - has a history of acute or chronic pancreatitis.
    - Knowledge or suspicion exists of alcohol, barbiturate, or amphetamine recreational or narcotic drug use (current or within 2 years prior to the screening visit) that in the investigator's opinion would compromise the subject's safety and/or compliance with study procedures.
    - has a condition that, in the opinion of the investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting or performing study requirements.
    - Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
    - received an investigational drug or used an investigational medical device within 90 days before the planned start of treatment.
    - has a confirmed grade 4 laboratory abnormality as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events or any other clinically relevant abnormalities in the opinion of the investigator. Subjects with grade 4 elevations in gammaglutamyltransferase (GGT) will be allowed to enter the study if there are no other clinically relevant laboratory abnormalities, as judged by the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to demonstrate the non-inferiority in sustained viral response (SVR12planned) of telaprevir administered as 1125 mg twice daily (b.i.d.) versus 750 mg every 8 hours (q8h) in combination with pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in treatment-naïve subjects with chronic HCV genotype 1 infection. SVR12planned is defined as having plasma HCV ribonucleic acid (RNA) levels < 25 IU/mL 12 weeks after the last planned dose of study drugs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after the last planned dose of study drugs.
    E.5.2Secondary end point(s)
    Secondary endpoints:
    - SVR week 72
    - RVR
    - relapse - virologic failure
    - viral breakthrough
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoint : time point
    SVR week 72 : week 72
    RVR : week 4
    relapse : throughout the duration of the study
    virologic failure : up to week 24 or 48
    viral breakthrough : up to week 24 or 48
    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 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
    non-inferiority study
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    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) 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 EEA57
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belgium
    Brazil
    France
    Germany
    Ireland
    Italy
    Mexico
    Poland
    Russian Federation
    Spain
    Sweden
    United Kingdom
    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
    LVLS
    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 months11
    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 months11
    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 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: 688
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 352
    F.4.2.2In the whole clinical trial 704
    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)
    Not different from standard treatment of that condition
    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 Decision2010-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-28
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