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    Summary
    EudraCT Number:2015-004061-87
    Sponsor's Protocol Code Number:Debio1562-201
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-07-16
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2015-004061-87
    A.3Full title of the trial
    A Phase 2 Study to Evaluate the Efficacy and Tolerability of Debio 1562 in Combination with Rituximab in Patients with Relapsed and/or Refractory Diffuse Large B-Cell Lymphoma and Other Forms of Non-Hodgkin’s Lymphoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to explore the efficacy and tolerability of Debio 1562 taken together with Rituximab in patients with diffuse large B-cell lymphoma (DLBCL) or other forms of non-Hodgkin's lymphoma (NHL) who have stopped responding or have failed to respond to current cancer treatments
    A.4.1Sponsor's protocol code numberDebio1562-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02564744
    A.5.4Other Identifiers
    Name:IND Number Number:109,517
    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 SponsorDebiopharm International S.A.
    B.1.3.4CountrySwitzerland
    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 supportDebiopharm International S.A.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDebiopharm International S.A.
    B.5.2Functional name of contact pointClinical Department
    B.5.3 Address:
    B.5.3.1Street AddressChemin Messidor 5-7, CP 5911
    B.5.3.2Town/ cityLausanne
    B.5.3.3Post code1002
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41213210111
    B.5.5Fax number+41213210169
    B.5.6E-mailClinicalTrials@debiopharm.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/15/1494
    D.3 Description of the IMP
    D.3.1Product nameDebio1562
    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 INNNot assigned
    D.3.9.1CAS number 1607824-64-5
    D.3.9.3Other descriptive nameDebio 1562
    D.3.9.4EV Substance CodeSUB180476
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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) 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 Yes
    D.2.1.1.1Trade name MabThera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical 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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    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 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
    Patients with Relapsed and/or Refractory Diffuse Large B-Cell Lymphoma and Other Forms of Non-Hodgkin’s Lymphoma
    E.1.1.1Medical condition in easily understood language
    Patients with DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) or other forms of non-Hodgkin's lymphoma (NHL) who have stopped responding or have failed to respond to current cancer treatments.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10012821
    E.1.2Term Diffuse large B-cell lymphoma recurrent
    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 23.0
    E.1.2Level PT
    E.1.2Classification code 10029601
    E.1.2Term Non-Hodgkin's lymphoma refractory
    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 23.0
    E.1.2Level PT
    E.1.2Classification code 10029600
    E.1.2Term Non-Hodgkin's lymphoma recurrent
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10012822
    E.1.2Term Diffuse large B-cell lymphoma refractory
    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 10076596
    E.1.2Term Marginal zone lymphoma
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10067070
    E.1.2Term Follicular B-cell non-Hodgkin's lymphoma
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10026801
    E.1.2Term Mantle cell lymphoma refractory
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10026800
    E.1.2Term Mantle cell lymphoma 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Determine the safety and tolerability of the proposed Debio 1562 dose regimens in combination with rituximab
    - Determine the anti-tumor activity of the proposed Debio 1562 dose regimens in combination with rituximab
    E.2.2Secondary objectives of the trial
    - Characterize the PK of Debio 1562 in combination with rituximab
    - Determine time to event outcomes [progression-free survival (PFS), time to response, duration of response (DOR), and overall survival (OS)]
    - Assess the immunogenicity of Debio 1562 (anti-drug antibodies, ADA) when administered in combination with rituximab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) For Part 1 of the study, patients must have histopathologically confirmed diagnosis of relapsed and/or refractory DLBCL, FL, MZL/MALT, MCL, or other Sponsor approved NHL subtypes according to the World Health Organization (WHO) classification 2008 for which standard measures do not exist or are no longer effective.
    2) For Part 2 and Part 3 of the study, patients must have histopathologically and clinically confirmed diagnosis of relapsed DLBCL. Patients will be considered to have a relapsed disease if they showed a duration of response of at least 24 weeks after their first line of therapy. The following patients with relapsed DLBCL will be enrolled:
    i. Patients who received only one line of previous therapy and achieved either complete response (CR) or partial response (PR) for at least 24 weeks (from the last day of the last cycle) after their first line of therapy, but whom are not eligible for high dose chemotherapy with autologous stem cell transplantation (HD-ASCT)
    ii. Patients who received more than one line of previous therapy (including HD-ASCT), and have achieved a duration of response (CR or PR) of at least 8 weeks (from the last day of the last cycle) after their last line of therapy
    3) Patients must have received no more than six prior treatment regimens. Prior treatment with an anti- CD20 agent, either alone or in combination, is allowed.
    4) Patients must be ≥ 18 years.
    5) Patients must have ECOG Performance Status 0-2.
    6) Patients must meet the following laboratory criteria:
    - Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L (1000/mm^3),
    - Platelet count ≥ 50 x 10^9/L (50,000/mm^3; patients must not have been transfused within 10 days previous blood drawn for laboratory assessment),
    -Patients receiving therapeutic anticoagulation are eligible provided their anticoagulation parameters are within range (e.g. International Normalized Ratio [INR] 2-3 on Coumadin if applicable) and they have no history of ≥ Grade 2 bleeding while on anticoagulatioin therapy.
    -For patients receiving therapeutic doses of anticoagulation: Platelet count ≥ 100 x 10^9/L (100,000/mm^3; must not have been transfused wihtin previous 10 days)
    - Hemoglobin ≥ 8.0 g/dL (may have been transfused),
    - Serum creatinine ≤ 2.0 x upper limit of normal (ULN) or 24-hour creatinine clearance of ≥ 60 mL/minute,
    - AST ≤ 2.5 x ULN; ALT ≤ 2.5 x ULN and
    - Total bilirubin ≤ 1.5 x ULN; patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin ≤ 3.0 x ULN.
    7) Patients must have evaluable or measurable disease in accordance with the International Working Group Guidelines for Lymphoma (Cheson 2014).
    8) Patients who are Hepatitis B surface antygen (HBsAg) + (must be PCR negative) who are taking antivirals are allowed to enroll.
    9) Male patients and female patients of child bearing potential participating in the study must agree to use two highly effective methods of contraception throughout this study and for at least 12 weeks after the last dose of Debio 1562 and 12 months after the last dose of rituximab. Examples of acceptable birth control methods include but are not limited to the following methods: (e.g, oral, parenteral, or implantable hormonal contraceptive; tubal ligation; intra-utérine device; barrier contraceptive with spermicide; partner's latex condom or vasectomy).
    10) Patients must be willing and able to sign the informed consent form and comply with the study protocol.
    11) Patients must have available a pathology-informed fresh or archived tumor tissue biopsy reflecting the current DLBCL disease. If the tissue biopsy is older than 18 months from the screening visit and a fresh one cannot be available, patients should provide fine needle
    aspiration (FNA) samples.
    E.4Principal exclusion criteria
    1) Patients with a diagnosis of CLL or Small Lymphocytic Lymphoma.
    2) For Part 2 and Part 3 of the study, patients with primary refractory DLBCL (defined as progression of disease within 24 weeks after first line of treatment).
    3) For Part 2 and Part 3 of the study, patients that are eligible to undergo first time HD-ASCT.
    4) For Part 2 and Part 3 of the study, patients with R/R FL, MZL/MALT, MCL, or any other NHL subtypes according to the WHO classification.
    5) The following exclusions, with regard to prior therapy apply:
    - Not recovered from prior chemotherapy or radiation as per Investigator’s judgment.
    - Anti-CD20 monoclonal antibody therapy within 14 days of starting study treatment.
    - Prior therapy with other anti-CD37-targeting therapy.
    - Radioimmunotherapy within two months prior to starting study treatment.
    - Small molecule anti-cancer therapeutic agent, and all investigational agents within 5 x t½ or 14 days whichever is shorter.
    - Allogeneic stem cell transplantation in the safety run-in period. In Part 2 and Part 3 of the study, patients who have had an allogeneic stem cell transplant may be eligible if their GVHD is controlled, after investigator/Sponsor discussion.
    - Chronic, systemic treatment with corticosteroids unless the dose has been stable for >7 days and is equivalent to ≤ 10 mg of prednisone per day.
    - Patients who have not recovered from prior surgery. Patients must have recovered or stabilized from the side effects of any major or minor surgical procedures prior to study treatment.
    6) Patients who have had a prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate antibody administration.
    7) Patients who have known central nervous system, meningeal, or epidural disease including brain metastases.
    8) Patients who have received or are to receive vaccination with live viruses within 30 days of Cycle 1 Day1.
    9) Impaired cardiac function or clinically significant cardiac disease such as:
    - New York Heart Association Class III or IV cardiac disease, including preexisting clinically significant ventricular arrhythmia, congestive heart failure, or cardiomyopathy;
    - Unstable angina pectoris ≤ 6 months prior to starting study drug;
    - Acute myocardial infarction ≤ 6 months prior to starting study drug; or
    - Other clinically significant heart disease e.g., ≥ grade 3 hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen.
    10) Patients with ≥ Grade 2 peripheral neuropathy.
    11) Patients with active hepatitis A, B or C infection.
    12) Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, psychiatric illness that would limit compliance with study requirements, active autoimmune disease requiring immunosuppressive therapy, severe immune deficiency.
    13) Known diagnosis of human immunodeficiency virus (HIV) infection.
    14) Patients with a concurrent primary malignancy that requires treatment or that would confound the disease response interpretation for the disease under study.
    15) WCBP who are pregnant or breast feeding.
    16) Patients currently presenting interstitial lung disease, diffuse parenchymal lung disease, or with a past history of severe/Grade 3 parenchymal lung disorders.
    E.5 End points
    E.5.1Primary end point(s)
    - Treatment-emergent adverse events (TEAES), clinically-significant changes in clinical laboratory test results, ECG and vital sign measurements
    - Number of patients with clinical responses as assessed by the Lugano Classification of response assessments.
    E.5.1.1Timepoint(s) of evaluation of this end point
    -AEs will be monitored continuously throughout the study from the time of the first dose of study treatment until 30 days after the patient's last study treatment or until the event has resolved or stabilized or an outcome has been reached, whichever comes first.
    Clinical laboratory tests will be performed at each study visit.
    ECG assessments will be performed at each IMP dosing visit, at D2 visits in each study part; at screening visit, at EOT visit and possibly at 30-day FU visit.
    Vital signs will be assessed at each study visit, except for the D2 and D3 visits in each study part (i.e. C1D2/C1D3 and C3D2/C3D3 in study part 1 (Q3W) and C1D2/C1D3 and C2D2/C2D3 in study part 2 (Q3W and QW)).
    - Performed approximately every 6 weeks, beginning at C1D1.
    E.5.2Secondary end point(s)
    - PK parameters (evaluated as deemed appropriate but not limited to): Cmax, AUC0-t,AUCinf terminal half-life (t½), clearance (CL), volume of distribution at steady state (Vss), Tmax, for both Debio 1562 and rituximab
    - Calculation of time to event parameters
    - Progression-free survival (PFS) and Overall survival (OS)
    - Time to response and duration of response (DOR)
    - Immunogenicity of Debio 1562: presence of human anti-drug antibody (ADA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - PK parameters will be assessed at each study visit
    - Calculation of time to event parameters will be assessed as follows:
    - PFS: Every 12 weeks (± 4 weeks) from time of last on-study tumor assessment until PD, or starting a subsequent anti-cancer therapy.
    - OS: Every 12 weeks (± 4 weeks) from time of 30-day FU visit, for up to 1 year from last patient’s first dose (C1D1)
    - Time to response and DOR will be estimated for all evaluable patients who achieve an objective response (PR or CR)
    - ADA assessment performed at D1 of each cycle, EOT visit and 30-day FU visit
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 No
    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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Ukraine
    United States
    Belgium
    Bulgaria
    Czechia
    Hungary
    Italy
    Poland
    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
    The End of Study will be defined as the latter of the completion of the Safety follow-up visit for the last patient remaining on treatment or one year from the last accrued patient’s first visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 34
    F.4.2.2In the whole clinical trial 75
    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)
    None
    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 Decision2018-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-06-25
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    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
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