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    Summary
    EudraCT Number:2013-003358-25
    Sponsor's Protocol Code Number:PC10VAC02
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-11-05
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFinland - Fimea
    A.2EudraCT number2013-003358-25
    A.3Full title of the trial
    A double-blind, randomised, placebo-controlled, Phase II study to evaluate ProCervix efficacy to clear HPV 16 and HPV 18 infection in women with normal cytology or ASCUS/LSIL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Therapeutic vaccine with objective to clear HPV 16 and 18 genital infections and therefore to prevent cervical pre-cancerous lesions.
    A.3.2Name or abbreviated title of the trial where available
    Phase II study of HPV vaccine in HPV infected women with normal cytology/ASCUS/LSIL
    A.4.1Sponsor's protocol code numberPC10VAC02
    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 SponsorGenticel
    B.1.3.4CountryFrance
    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 supportGenticel
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointSylvie Fradet
    B.5.3 Address:
    B.5.3.1Street Address27/35 Rue Victo Hugo
    B.5.3.2Town/ cityIvry Sur Seine
    B.5.3.3Post code94853
    B.5.3.4CountryFrance
    B.5.4Telephone number+33182880887
    B.5.5Fax number+33985694359
    B.5.6E-mailsylvie.fradet@ppdi.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 name.
    D.3.2Product code GTL001
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeC16-1
    D.3.9.3Other descriptive namerecombinant CyaA-HPV16E7
    D.3.9.4EV Substance CodeSUB117969
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.75
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeC18-1
    D.3.9.3Other descriptive namerecombinant CyaA-HPV18E7
    D.3.9.4EV Substance CodeSUB117970
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.75
    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) Yes
    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.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 ALDARA 5% CREAM
    D.2.1.1.2Name of the Marketing Authorisation holderMeda AB
    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 nameImiquimod
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIMIQUIMOD
    D.3.9.1CAS number 99011-02-6
    D.3.9.4EV Substance CodeSUB12453MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 Aqua ad iniectabilia Braun
    D.2.1.1.2Name of the Marketing Authorisation holderB Braun Melsungen 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 nameWater for injection
    D.3.4Pharmaceutical form Solvent for parenteral use
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameWATER FOR INJECTION
    D.3.9.4EV Substance CodeSUB12398MIG
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboIntradermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Women infected by HPV 16 and/or HPV 18 with normal cytology or ASCUS/LSIL
    E.1.1.1Medical condition in easily understood language
    Human Papillomavirus infection before precancerous cervical smear.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10064328
    E.1.2Term Human papilloma virus test positive
    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
    To evaluate the efficacy of ProCervix adjuvanted with imiquimod, in comparison with placebo adjuvanted with imiquimod, to induce HPV 16 and 18 viral clearance at 12 months in HPV 16 and/or 18 infected women using a type specific, sensitive and quantitative HPV polymerase chain reaction (PCR) assay.
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of ProCervix adjuvanted with imiquimod, in comparison with placebo to induce HPV 16 and 18 sustained viral clearance.
    2. To evaluate the efficacy of ProCervix adjuvanted with imiquimod, in comparison with placebo , to induce HPV 16 and/or 18 viral clearance at 6, 12, 15, 18 and 24 months.
    3. To evaluate the safety and tolerability of ProCervix adjuvanted with imiquimod.

    Exploratory (in brief):
    1. To assess HPV 16 and/or HPV 18 viral clearance at one or more timepoints up to 12, 18 and 24 months in HPV 16 and/or 18 infected woman.
    2. To evaluate the cellular and humoral immunogenicity of ProCervix adjuvanted with imiquimod.
    3. To assess regression of cytological abnormalities and histological lesions at 12, 18 and 24 months in subjects with HPV 16 and/or HPV 18-associated ASCUS/LSIL at enrolment.
    4. To assess the prevention of progression to CIN2+ in HPV 16 and/or 18 infected women 18 and 24 months after first immunisation.





    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject will be eligible for inclusion in this study if the following criteria apply:
    1. Subject is female between the ages of 25 and 50 years (inclusive).
    2. Subject is pre-menopausal (referring to the time period preceding menopause, excluding perimenopause) and not on hormone replacement therapy (HRT).
    3. Subject must have cervical HPV 16 and/or 18 infection confirmed by Riatol realtime polymerase chain reaction (RT-PCR) assay at baseline. Subject can be co-infected with other HPV serotypes.
    4. Subject has a cervical cytological evaluation with a normal, ASCUS or LSIL result at baseline.
    5. Subject has employed highly effective contraception the month prior to the first vaccination and will agree to employ highly effective contraception for at least 12 months after the first vaccination. Highly effective methods of birth control include those that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectable, combined oral contraceptives, levonorgestrel-releasing intrauterine system, intra-uterine devices (IUDs), vasectomised partner and true sexual abstinence.
    6. Subject is in general good health based on medical history and physical examination.
    7. Subject is able to communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
    8. Subject voluntarily gives written informed consent to participate in the study.
    E.4Principal exclusion criteria
    A subject who meets any of the following exclusion criteria must not be enrolled:
    1. Subject has a current acute or chronic disease, other than infection with HPV, which would be expected to interfere with the planned evaluations of response to ProCervix, in the judgment of the Investigator.
    2. Subject has vaginal atrophy with or without topical hormonal therapies or systemic selective estrogen receptor modulators (SERMs).
    3. Subject has prior exposure to HPV prophylactic vaccine or subject has participated in the past in another vaccination clinical trial related to infection with HPV including vaccination with ProCervix.
    4. Current high grade lesions or history of untreated high grade cervical lesion (either CIN2 or CIN3).
    5. Subject has current or a history of cancer of the cervix.
    6. Subject has clinically significant (CS) gynaecological abnormalities that could interfere with study evaluation, in the judgment of the Investigator (e.g. prolapse, myoma, fibroid, hysterectomy).
    7. Subject has a laboratory abnormality Grade ≥ 2, as defined using the Toxicity
    Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in
    Preventative Vaccine Clinical Trials for the following parameters:
    - haemoglobin (Hb)
    - haematocrit (Hct)
    - white blood cell count (WBC)
    - lymphocytes
    - neutrophils
    - eosinophils
    - platelet count (plt)
    - urea nitrogen (BUN)
    - creatinine
    - alanine aminotransferase (ALT)
    - aspartate aminotransferase (AST)
    - alkaline phosphatase (ALP)
    - total bilirubin (Tbili)
    - prothrombin time (PT)
    8. Subject has received any live viral vaccine within 3 months or any other non-live vaccine within 2 weeks prior to screening.
    9. Subject has primary or secondary systemic immunosuppression (defined as prolonged [≥ 7 days] use of corticosteroids that is greater than or equal to 20 mg of prednisone-equivalent per day or any other immunosuppressive drug).
    10. Subject has a history of severe allergy (requiring hospital care) or history of severe asthma requiring oral or parenteral drug management in the last year (treatments with inhaled corticosteroids, short-acting beta agonists [SABA], long-acting beta agonists [LABA] or theophylline are allowed).
    11. Subject has a history malignancy, except the following adequately treated cancers: basal cell carcinoma, or dermatological squamous cell carcinoma.
    12. Subject was administered with another investigational drug or vaccine within 30days prior to the screening visit or is participating in any other study.
    13. Subject has a known hypersensitivity to imiquimod.
    14. Subject has a history of severe reaction to any drug, include kamamycin or vaccination.
    15. Subject has a medical condition with clinical and/or biological consequences judged by the Investigator incompatible with vaccination(s).
    16. Subject has positive results for human immunodeficiency virus (HIV), hepatitis B virus (HBV) surface antigen (HBsAg), or hepatitis C virus (HCV).
    17. Subject has a symptomatic vaginal or genital infection (for example, symptomatic candida infection). If appropriate in the judgment of the Investigator, subjects with symptomatic infection may be treated and reconsidered for enrolment after resolution of the symptomatic infection.
    18. Subject has a history of or currently active genital herpes disease.
    19. Subject is pregnant or is breastfeeding.
    20. Subject has a positive serum human chorionic gonadotrophin (HCG) result at enrolment.
    E.5 End points
    E.5.1Primary end point(s)
    The clearance (non detection of HPV 16 and or HPV18 DNA by RT-PCR at one specific visit) at Month 12 of HPV 16 and HPV 18 infection using a type specific, sensitive and quantitative HPV PCR assay.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At month 12 clearance of HPV 16 and 18 infection.
    E.5.2Secondary end point(s)
    Secondary virology endpoints:
    1. Clearance at Month 6, 15, 18 and 24 of HPV 16 and HPV 18 infection.
    2. Confirmed clearance of HPV 16 and HPV 18 infection at two consecutive visits at least 6 months apart.
    3. Sustained clearance of HPV 16 and HPV 18 infection. Of note: Unless otherwise specified, missing data will not be replaced. However, some imputation of missing data might be performed for some efficacy analyses as detailed in the Statistical Analysis Plan.
    4. Time to the first clearance of HPV 16 and HPV 18 infection.
    5. Duration of the first clearance of HPV 16 and/or HPV 18 infection.
    6. Proportion of incident HPV 16 or HPV 18 infections when absent at baseline.

    Safety:
    1. Occurrence, intensity, duration and relationship of any solicited local and general reactions during a 14-day follow-up period after each ProCervix or placebo dose.
    2. Occurrence, intensity, duration and relationship of unsolicited adverse events occurring during the 14-day period following each vaccination and throughout the study.
    3. Occurrence and relationship of all SAEs occurring throughout the study period.
    4. Haematologic and biochemical levels outside the normal laboratory ranges at each specified visit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Months 6, 15, 18 and 24 of infection.
    2. Measured on Month 12, 18 and 24 of trial period.
    3. Measured on Month 24 of trial period.
    4/5/6. Measured on Month 6, 12, 15, 18 and 24 of trial period.

    Safety:
    1. 14-day follow up period (i.e. day of administration and 13 subsequent days).
    2. 14-day period following each vaccination and throughout the study
    3/4. Study period
    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 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.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 222
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 222
    F.4.2.2In the whole clinical trial 222
    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)
    The patients will receive medical care as per the institution standard of care. There will be no treatment proposed by Genticel after the subject has ended their participation in the trial.
    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 Decision2013-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-03
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