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   42312   clinical trials with a EudraCT protocol, of which   6968   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    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:2016-004718-90
    Sponsor's Protocol Code Number:UTX-TGR-205
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-08-09
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2016-004718-90
    A.3Full title of the trial
    A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib with or without Bendamustine and Umbralisib alone in Patients with Previously Treated Non-Hodgkin’s Lymphoma
    Randomizované klinické skúšanie fázy IIb, posudzujúce účinnosť a bezpečnosť kombinácie ublituximabu + umbralisibu s alebo bez bendamustínu a umbralisibu samotného u pacientov v minulosti liečených pre Non-Hodgkinov lymfóm.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial in patients with previously-treated Non-Hodgkin's Lymphoma evaluating the safety and effectiveness of:
    -the combination of ublituximab + umbralisib
    -the combination of ublituximab + umbralisib + bendamustine and
    -umbralisib alone.
    Klinické skúšanie u pacientov v minulosti liečených pre Non-Hodgkinov lymfóm posudzujúce účinnosť a bezpečnosť:
    - kombinácie ublituximabu + umbralisibu
    - kombinácie ublituximabu + umbralisibu + bendamustínu
    - umbralisibu samotného
    A.4.1Sponsor's protocol code numberUTX-TGR-205
    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 SponsorTG Therapeutics
    B.1.3.4CountryUnited States
    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 supportTG Therapeutics
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBrillance Sp. z o.o.
    B.5.2Functional name of contact pointIzabela Kozdraś
    B.5.3 Address:
    B.5.3.1Street AddressKrólowej Jadwigi 167 b
    B.5.3.2Town/ cityKraków
    B.5.3.3Post code30-212
    B.5.3.4CountryPoland
    B.5.4Telephone number+48668166876
    B.5.5Fax number+48327390088
    B.5.6E-mailikozdras@brillance.pl
    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 nameUblituximab
    D.3.2Product code TG-1101
    D.3.4Pharmaceutical form Solution for injection
    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 INNUBLITUXIMAB
    D.3.9.1CAS number 1174014-05-1
    D.3.9.2Current sponsor codeTG-1101
    D.3.9.3Other descriptive nameLFB-R603, TGTX1101
    D.3.9.4EV Substance CodeSUB182428
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameUmbralisib
    D.3.2Product code TGR-1202
    D.3.4Pharmaceutical form 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 INNTGR-1202
    D.3.9.2Current sponsor codeTGR-1202
    D.3.9.3Other descriptive nameRP-5307 (pTSA Salt), RP-5264 (free base)
    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 Bendamustine (Levact)
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameLavact
    D.3.4Pharmaceutical form Powder for 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 INNBENDAMUSTINE HYDROCHLORIDE
    D.3.9.1CAS number 3543-75-7
    D.3.9.4EV Substance CodeSUB00696MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.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
    Non-Hodgkin’s Lymphoma
    E.1.1.1Medical condition in easily understood language
    Non-Hodgkin’s Lymphoma is a group of blood cancers that includes all types of lymphoma except Hodgkin's lymphomas. Lymphomas are types of cancer that develop from lymphocytes -type of white blood cell
    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 HLGT
    E.1.2Classification code 10025322
    E.1.2Term Lymphomas non-Hodgkin's unspecified histology
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of (1) umbralisib alone, (2) umbralisib plus ublituximab, and in select NHL subtypes, (3) umbralisib plus ublituximab plus bendamustine as measured by Overall Response Rate (ORR)
    E.2.2Secondary objectives of the trial
    SECONDARY OBJECTIVES
    - To assess the efficacy of (1) umbralisib alone, (2) umbralisib plus ublituximab, and in select NHL subtypes, (3) umbralisib plus ublituximab plus bendamustine as measured by Progression-Free Survival (PFS) and Duration of Response (DOR)
    - To assess safety, tolerability and other efficacy outcomes.
    - To analyze population pharmacokinetics and any other potential drug-drug interactions of ublituximab and umbralisib

    EXPLORATORY OBJECTIVES
    - To observe the impact of cell of origin, mutational status, and select other biomarkers on efficacy of the umbralisib and the ublituximab + umbralisib combination in subjects with DLBCL
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all the following inclusion criteria to be eligible for participation in this study:
    1. Histologically confirmed diagnosis of: B-cell NHL with histological subtype limited to the following based on criteria established by the World Health Organization (WHO) 2008 classification of tumors of hematopoietic and lymphoid tissues:
    a. Follicular Lymphoma (FL) of Grade 1, 2, or 3a;
    b. Marginal Zone Lymphoma (MZL) (splenic, nodal, or extranodal); or
    c. Mantle Cell Lymphoma (MCL) – with documentation of either overexpression of cyclin D1 or t(11;14).
    d. Note: Subjects with Diffuse Large B-Cell Lymphoma (DLBCL) and Small Lymphocytic Lymphoma (SLL) were previously eligible, however new subject enrollment for these subtypes is closed in protocol V5.0.
    e. As of protocol V6.0 - Small Lymphocytic Lymphoma (SLL) subjects are eligible for enrollment.
    2. Treatment status:
    a. Protocol V6.0 - FL, SLL, MZL subjects: treatment naïve or previously treated with a maximum of two prior lines of therapy (excluding antibiotics). FL subjects must have documented evidence for requiring treatment (one or more of the following: bulky disease [>5 cm], high LDH, B symptoms, threatened organ function, splenomegaly, cytopenias due to lymphoma, or effusions);
    b. Protocol V3.0 - V5.1 (closed) - FL subjects: relapsed or refractory after ≥ 2 prior lines of systemic therapy. Subjects must have received an anti-CD20 mAb and an alkylating agent, and must have documented evidence for requiring treatment (one or more of the following: bulky disease [>5 cm], high LDH, B symptoms, threatened organ function, splenomegaly, cytopenias due to lymphoma, or effusions);
    c. Protocol V2.0 - V5.1 (closed) - MZL subjects: prior treatment with one or more lines of therapy including at least one CD20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least PR or documented PD after the most recent systemic treatment regimen, and must have documented evidence for requiring treatment (one or more of the following: bulky disease [>5 cm], high LDH, B symptoms, threatened organ function, splenomegaly, cytopenias due to lymphoma, or effusions);
    d. Protocol V4.0 - V6.0 - MCL subjects: prior treatment with one or more lines of therapy including at least one BTK inhibitor (either ibrutinib, acalabrutinib, or zanibrutinib only) with documented failure to achieve at least PR or documented PD during, or within 6 months of discontinuing, prior BTK therapy;
    3. Measurable disease, defined as at least 1 measurable disease lesion > 1.5 cm in at least one diameter by CT/CT-PET or magnetic resonance imaging (MRI) in an area of no prior radiation therapy, or in an area that was previously irradiated that has documented progression.
    4. Adequate organ system function, defined as follows:
    a. Absolute neutrophil count (ANC) > 1,000/mm3 (µL) & platelet count > 50,000/mm3 (µL)
    b. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN)
    c. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN if no liver involvement or ≤ 5 x the ULN if known liver involvement
    d. Calculated creatinine clearance ≥ 30 mL/min (as calculated by the Cockcroft-Gault formula)
    5. ECOG performance status ≤ 2
    6. Male or female ≥ 18 years of age
    7. Ability to swallow and retain oral medication
    8. Female subjects who are not of child-bearing potential (see Appendix B- Contraceptive Guidelines and Pregnancy), and female subjects of child-bearing potential who have a negative serum pregnancy test within 3 days prior to Cycle 1, Day 1. Female subjects of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception throughout the study period and for 4 months after the last dose of either study drug.
    9. Willingness and ability to comply with trial and follow-up procedures, and give written informed consent.
    E.4Principal exclusion criteria
    Subjects who meet any of the following exclusion criteria are not to be enrolled to this study:
    1. Subjects receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) or any investigational drug within 21 days of Day 1 of Cycle 1.
    a. Corticosteroid therapy started at least 7 days prior to study entry (prednisone ≤ 10 mg daily or equivalent) is allowed as clinically warranted. Topical or inhaled corticosteroids are permitted.
    b. Palliative radiation therapy is allowed as clinically warranted.
    2. Subjects who have received autologous hematologic stem cell transplant within 6 months of study entry. Prior allogeneic hematologic stem cell transplant is excluded.
    3. Evidence of chronic active Hepatitis B (HBV) as evidenced by a detectable hepatitis B surface antigen (not including subjects with prior hepatitis B vaccination) or chronic active Hepatitis C infection (HCV), cytomegalovirus (CMV), or known history of HIV. If HBc antibody, HCV antibody or CMV IgG or IgM is positive the subject must be evaluated for the presence of HBV DNA, HCV RNA, or CMV DNA by PCR - See Appendix D - Hepatitis B Serologic Test Results.
    4. Known history of Central Nervous System (CNS) lymphoma; subjects with symptoms of CNS disease must have a negative MRI scan and negative diagnostic lumbar puncture.
    5. Known histological transformation from chronic lymphocytic leukemia to large cell lymphoma (i.e. Richter’s transformation)
    6. Evidence of ongoing systemic bacterial, fungal or viral infection, except localized fungal infections of skin or nails.
    7. History of anaphylaxis (excluding infusion related reactions) in association with previous anti-CD20 administration (for subjects eligible to enroll to an ublituximab containing regimen only).
    8. Prior exposure to idelalisib (CAL-101), duvelisib (IPI-145), copanlisib or any other drug that specifically inhibits phosphoinositide-3-kinase (PI3K)
    9. Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
    a. Symptomatic, or history of documented congestive heart failure (NY Heart Association functional classification III-IV [see Appendix C – NYHA Classifications])
    b. Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of randomization
    c. Concomitant use of medication known to cause QT prolongation or torsades de pointes should be used with caution and at investigator discretion.
    d. Poorly controlled or clinically significant atherosclerotic vascular disease including cerebrovascular accident (CVA), transient ischemic attack (TIA), angioplasty, cardiac/vascular stenting within 6 months of enrollment
    10. Malignancy within 3 years of study enrollment except for adequately treated basal, squamous cell carcinoma or non-melanomatous skin cancer, carcinoma in situ of the cervix, superficial bladder cancer not treated with intravesical chemotherapy or BCG within 6 months, localized prostate cancer and PSA < 1.0 mg/dL on 2 consecutive measurements at least 3 months apart with the most recent one being within 4 weeks of study entry.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoints
    Overall response rate (ORR) : ORR is defined as sum of CR and PR rates.

    E.5.1.1Timepoint(s) of evaluation of this end point
    During the study period, all subjects will be evaluated for response by CT, PET-CT and/or MRI at the end of Cycle 3 and then within 14 days prior to Day 1 of Cycles 6, 9, and 12. After Cycle 12, response assessments should occur every 6 cycles or more frequently as clinically indicated. All baseline assessments to characterize disease will be performed within 30 days of Cycle 1 Day 1, prior to initiation of therapy. During the treatment period, all efficacy assessments have a +/- 14 day window.
    E.5.2Secondary end point(s)
    Progression-free survival (PFS) at Month 6
    PFS at Month 6 is defined as the percent of subjects not experiencing progression (i.e., definitive disease progression or death from any cause) by Month 6.

    Progression-free survival (PFS)
    PFS is defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression based on standard criteria (Cheson et al., 2007).

    Complete Response (CR) Rate
    CR rate is defined as the proportion of subjects who achieve a CR.

    Overall survival (OS)
    OS is defined as the interval from randomization to death from any cause

    Duration of Response (DOR)
    Duration of response is defined as the time from documentation of a response to treatment to the first documentation of tumor progression or death due to any cause, whichever comes first.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the study period, all subjects will be evaluated for response by CT, PET-CT and/or MRI at the end of Cycle 3 and then within 14 days prior to Day 1 of Cycles 6, 9, and 12. After Cycle 12, response assessments should occur every 6 cycles or more frequently as clinically indicated. All baseline assessments to characterize disease will be performed within 30 days of Cycle 1 Day 1, prior to initiation of therapy. During the treatment period, all efficacy assessments have a +/- 14 day window
    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 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 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 No
    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.8.2.4Number of treatment arms in the trial4
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Israel
    Italy
    Korea, Republic of
    Poland
    Slovakia
    Spain
    United Kingdom
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months7
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 205
    F.4.2.2In the whole clinical trial 800
    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)
    For subjects subsequent treatment should be available at the discretion of their treating physician.
    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 Decision2017-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-20
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA