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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43839   clinical trials with a EudraCT protocol, of which   7280   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2020-000954-86
    Sponsor's Protocol Code Number:107CS-5
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-08-04
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2020-000954-86
    A.3Full title of the trial
    A Multinational, Multicenter, Open-label, Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of Oral Paclitaxel (DHP107) Compared to IV Paclitaxel as First-line Therapy in Patients with Recurrent or metastatic HER2 negative Breast Cancer
    ''Международно, многоцентрово, отворено, фаза 2/3, клинично
    изпитване за оценка на ефикасността и безопасността на паклитаксел
    за перорално приложение (DHP107) в сравнение с паклитаксел за
    интравенозно приложение като първа линия на терапия при пациенти с
    рецидивиращ или метастатичен HER2-отрицателен рак на гърдата''
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multinational, Multicenter, Open-label, Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of Oral Paclitaxel (DHP107) Compared to IV Paclitaxel as First-line Therapy in Patients with Recurrent or metastatic HER2 negative Breast Cancer
    A.4.1Sponsor's protocol code number107CS-5
    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 SponsorDaehwa Pharmaceutical Co., Ltd.
    B.1.3.4CountryKorea, Republic of
    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 supportDaehwa pharmaceutical Co., Ltd.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHT Research BG Ltd.
    B.5.2Functional name of contact pointNenad Nikolic
    B.5.3 Address:
    B.5.3.1Street Address30-32 Gen. E.I.Totleben blvd., fl. 2, Krasno Selo District
    B.5.3.2Town/ citySofia
    B.5.3.3Post code1606
    B.5.3.4CountryBulgaria
    B.5.4Telephone number+359886699621
    B.5.5Fax number+35929051905
    B.5.6E-mailnenikolic@Hungarotrial.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 Yes
    D.2.1.1.1Trade name Liporaxel
    D.2.1.1.2Name of the Marketing Authorisation holderDaehwa Pharmaceutical Co., Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationKorea, Republic of
    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 nameLiporaxel
    D.3.2Product code DHP107
    D.3.4Pharmaceutical form Oral solution
    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 INNPaclitaxel
    D.3.9.1CAS number 33069-62-4
    D.3.9.2Current sponsor codeDHP107
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 RoleComparator
    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 Taxol
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Co.
    D.2.1.2Country which granted the Marketing AuthorisationTaiwan
    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 nameTaxol
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPaclitaxel
    D.3.9.1CAS number 33069-62-4
    D.3.9.3Other descriptive nameintravenous paclitaxel
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent or metastatic HER2 negative Breast Cancer
    E.1.1.1Medical condition in easily understood language
    Breast cancer patients with recurrent or metastatic HER2 gene negative
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006198
    E.1.2Term Breast cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of oral paclitaxel by comparing the progression-free survival (PFS) of treatment with oral paclitaxel and IV paclitaxel in subjects with Recurrent or metastatic HER2 negative breast cancer.
    E.2.2Secondary objectives of the trial
    To assess oral paclitaxel compared to IV paclitaxel in terms of the following endpoints in subjects with recurrent or metastatic HER2 negative breast cancer:
    - Objective response rate (ORR)
    - Overall survival (OS)
    - Time to treatment failure (TTF)
    - Disease control rate (DCR)
    - Quality of life (QoL) as the EQ-5D-3L
    - Safety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Subjects who are ≥ 19 years of age on the date of written informed consent.
    2) Subjects with confirmation of primary, recurrent or metastatic HER2 negative breast cancer based on histopathology examination (tumor characteristics should be confirmed by histological or cytological evaluation). However, in case of a metastasis or recurrence, it is not required to be verified again by histopathology, i.e it is possible to register with imaging alone.
    (1) Subjects are eligible for the study regardless of hormone receptor status (ER/PR positive or negative).
    (2) ER/PR(+) is defined as cells expressing hormone receptors >1% in immunohistochemistry (IHC) analysis of collected samples.
    3) HER2-negative from tumor sample (primary or metastatic) is confirmed with one of the followings as NCCN guiline 20197 (HER2 test should be performed using samples of metastatic site, if metastasis is confirmed and samples can be collected from the metastatic lesions.)
    (1) HER2 negative by validated immunohistochemistry (IHC) assay:
    - IHC 0, 1+
    - When IHC 2+, must reflex test with ISH (if same specimen), or order new test with IHC or dual probe in situ hybridization (ISH) (if new specimen available)
    (2) HER2 negative by validated dual-probe ISH assay:
    - HER2/CEP17 ratio < 2.0 and average HER2 copy number < 4.0 signals/cell
    (3) HER2 negative by concurrent IHC and ISH results:
    - HER2/CEP17 ratio ≥ 2.0 and average HER2 copy number < 4.0 signals/cell and concurrent IHC 0-1+ or 2+
    - HER2/CEP17 ratio < 2.0 and average HER2 copy number ≥ 6.0 signals/cell and concurrent IHC 0-1+
    - HER2/CEP17 ratio < 2.0 and average HER2 copy number ≥ 4.0 and <6.0 signals/cell and concurrent IHC 0-1+ or 2+
    4) Subjects with life expectancy ≥ 12 weeks
    5) Subjects with Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    6) Subjects with measurable or evaluable lesions identified by RECIST version 1.1. (However, for phase II study, only subjects with measurable lesions can be enrolled.)
    7) Subjects with confirmed adequate hematologic, renal and liver function as follows:
    (1) Absolute neutrophil count (ANC) ≥ 1,500/μL
    (2) Platelet ≥ 100,000/μL
    (3) Hemoglobin ≥ 9.0 g/dL
    (4) Serum creatinine ≤ 1.5 X ULN (but, subjects with CrCl or eGFR ≥ 60 mL/min may participate)
    (5) Serum calcium level ≤ 12 mg/dL
    (6) Total bilirubin ≤ 1.5 X ULN (except for elevated total bilirubin due to Gilbert’s Syndrome)
    (7) Liver function tests:
    - If there is no evidence of liver metastases: ALT and AST ≤ 2.5 x ULN
    - If liver metastases are documented: ALT and AST ≤ 5 x ULN
    8) If subjects with central nervous system metastasis who should be stable for more than 4 weeks prior to randomization
    (1) If subjects have a history of steroid administration, such patient can participate if he/she have discontinued steroid, or reduce or maintain dexamethasone administration of up to 4mg per day (or equivalent dosage) for more than 4 weeks prior to randomization date.
    (2) Brain-imaging should be used to confirm that there are no new lesions and if subjects have symptoms of CNS metastasis, the investigator should use brain-imaging to confirm such case, at the investigator’s discretion.
    9) Subjects who understand and are willing to comply with the protocol at the judgment of the investigator
    10) Subjects who voluntarily agree to participate in the study and sign the informed consent form
    E.4Principal exclusion criteria
    1) Subjects expected to have hypersensitivity to active ingredient and any component of this investigational product.
    2) Subjects who previously received drugs of taxane class (subjects who administer the last dose of drug of taxane class ≥ 1 year ago as from the randomization day and have recurrence confirmed can be enrolled)
    3) Subjects receiving chemotherapy for recurrent or metastatic HER2 negative breast cancer before screening for the study. However, the following subjects should be allowed to participate:
    (1) Subjects who had the last administration of adjuvant or neoadjuvant chemotherapy from randomization for prior breast cancer that is not recurrent or metastatic, and its toxic symptoms have disappeared.
    (2) ER/PR(+) subjects can be enrolled regardless of lines of endocrine therapy. (Alone or with CDK4/6 inhibitors, or mTOR inhibitors.)
    4) Subjects who received radiotherapy within 2 weeks from the randomization day (subjects who have completed local radiotherapy as palliative therapy for the purpose of pain relief for sites (eg, sites of bone metastasis, etc.) other than the target lesion and have recovered from the resulting acute toxicity (eg, bone marrow suppression) can participate.)
    5) Subjects with confirmed heart failure of New York Heart Association (NYHA) class 2 or higher, or clinically significant arrhythmia uncontrolled by drug treatments, at the time of study entry.
    6) Subjects with confirmed cardiovascular disease (including unstable angina pectoris, myocardial infarction, stroke, and transient ischemic attack) that occurred within 24 weeks prior to study entry, which is deemed to be clinically significant by the investigator
    7) Subjects whose left ventricular ejection fraction (LVEF) measured by echocardiogram, MUGA scan, or standard procedures of study site is < lower limit of normal (50%, if the institutional lower limit of normal is not set) within 12 weeks prior to study entry
    8) Subjects with uncontrolled hypertension at the time of randomization (SBP > 140 mmHg or DBP > 90 mmHg despite drug treatments)
    9) Subjects who have a history of active hepatitis B or C, or hepatobiliary disorders confirmed by medical records or medical examination
    [However, the following subjects may participate:
    (1) Subjects with Gilbert’s Syndrome, asymptomatic gallstone, liver metastases, or stable chronic liver disease may participate at the discretion of the investigator.
    (2) Healthy carriers of hepatitis B who agree on prophylactic antiviral agent during chemotherapy or C virus can participate if HBV-DNA or HCV RNA titer is negative]
    10) Those who have been confirmed to be positive for human immunodeficiency virus (HIV) through medical records or medical examination
    11) Confirmed neuropathy grade ≥ 2 (based on CTCAE v4.03) at the time of study entry
    12) Subjects with confirmed uncontrolled intercurrent disease or condition including significant mental disease or social status which, in the investigator's judgment, may affect compliance with study procedures
    13) Subjects with a history of primary malignancy other than breast cancer. However, the subjects should be allowed to participate if:
    (1) It has been at least 5 years and they are disease-free since completion of tumor treatment
    14) Subjects who are expected to newly start prophylactic use of bisphosphonate or RANKL inhibitor for bone metastasis during clinical study, at the discretion of investigator. (However, subjects on the drug for bone metastasis or osteoporosis just before the IP administration can participate and are permitted for concomitant administration during the study. But in that case, the same Dose and Usage should be maintained during the clinical trial period).
    15) Subjects determined inappropriate to orally administer the IP at the time of study participation based on the investigator's judgment
    (1) Clinically significant or uncontrolled congenital or acquired gastrointestinal disease
    (2) Subjects with confirmed diseases that may interfere with the IP's administration, transfer to digestive tract, or absorption including ileus and inflammatory bowel disease (Crohn’s disease and ulcerative colitis)
    16) Pregnant or breast-feeding women
    17) Subjects of childbearing women and men (including partners) who are unwilling to remain abstinent nor use adequate contraception during the study and at least 12 weeks after the end of treatment
    18) Subjects who have participated in other clinical trials/studies within 2 weeks prior to the administration of this IP or who are scheduled to participate in other clinical trials/studies during this clinical trial period. (However, if the subject participated in control arm of active drug with market approval, he/she can be allowed by investigator’s discretion. Also, subjects who participated in an observational study with minimal medical intervention (e.g. blood or urine test) can also be allowed by investigator’s discretion.)
    19) Unable according to investigator
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Progression Free Survival (PFS) will be assessed up to 18 months.
    E.5.2Secondary end point(s)
    - Objective response rate (ORR)
    - Overall survival (OS)
    - Time to treatment failure (TTF)
    - Disease control rate (DCR)
    - Quality of life (QoL) as the EQ-5D-3L
    - Safety
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Objective Response Rate (ORR) will be followed every 6 weeks until progression, an expected average of 9 months.
    - Overall Survival(OS) will be followed until 6 months after the last participant is enrolled, assessed minimum to 18 months.
    - Time to Treatment Failure(TTF) will be followed through study completion, an expected average of 4.5 year.
    - Disease Control Rate(DCR)will be followed through study completion, an expected average of 4.5 year.
    - Quality of life(QoL) will be assessed C1D1, C2D1, C4D1, C7D1, C10D1 (each cycle is 28 days) and study completion, up to 18 months.
    - Safety will be assessed up to 28 days after last investigational product administration.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.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 Yes
    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) Yes
    E.8.2.2Placebo No
    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 EEA11
    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
    China
    Korea, Republic of
    Bulgaria
    Hungary
    Serbia
    E.8.7Trial has a data monitoring committee No
    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
    End of study is performed for all subjects when the last subject reaches their EOT or passes 18 months from the enrollment.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years5
    E.8.9.2In all countries concerned by the trial months10
    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: 556
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 556
    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
    Elderly
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 556
    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)
    All subjects will have safety follow-up visit 28 days (+7 days) from the date of the last dose. In safety follow-up visit, adverse events, concomitant medications, subsequent anti-cancer treatments, and
    death will be investigated. The survival follow-up will be performed every 12 weeks (±14 days) for the first year, and every 24 weeks (±14 days) from the second year onwards up to 5 years.
    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 Decision2020-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-17
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA