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    Summary
    EudraCT Number:2016-004262-26
    Sponsor's Protocol Code Number:VBP15-002
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-12-21
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-004262-26
    A.3Full title of the trial
    VBP15-002 A Phase IIa Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability,
    Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of Vamorolone in Boys with Duchenne Muscular
    Dystrophy (DMD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy
    (DMD)
    A.4.1Sponsor's protocol code numberVBP15-002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02760264
    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 SponsorReveraGen BioPharma, Inc.
    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 supportReveraGen BioPharma, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReveraGen BioPharma Inc
    B.5.2Functional name of contact pointJesse Damsker
    B.5.3 Address:
    B.5.3.1Street Address155 Gibbs St. Suite 433
    B.5.3.2Town/ cityRockville
    B.5.3.3Post codeMD 20850
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 215 680 8286
    B.5.6E-mailjesse.damsker@reveragen.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 numberEMA/OD/049/14
    D.3 Description of the IMP
    D.3.1Product name Vamarolone
    D.3.2Product code VBP15
    D.3.4Pharmaceutical form Oral suspension
    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 INNvamorolone
    D.3.9.1CAS number 13209-41-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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 numberEMA/OD/049/14
    D.3 Description of the IMP
    D.3.1Product nameVamorolone
    D.3.2Product code VBP15
    D.3.4Pharmaceutical form Oral suspension
    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 INNvamorolone
    D.3.9.1CAS number 13209-41-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    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 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 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 numberEMA/OD/049/14
    D.3 Description of the IMP
    D.3.1Product nameVamorolone
    D.3.2Product code VBP15
    D.3.4Pharmaceutical form Oral suspension
    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 INNvamorolone
    D.3.9.1CAS number 13209-41-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.0
    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: 4
    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 numberEMA/OD/049/14
    D.3 Description of the IMP
    D.3.1Product nameVamorolone
    D.3.2Product code VBP15
    D.3.4Pharmaceutical form Oral suspension
    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 INNvamorolone
    D.3.9.1CAS number 13209-41-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.0
    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
    Duchenne muscular dystrophy (DMD)
    E.1.1.1Medical condition in easily understood language
    Duchenne muscular dystrophy (DMD)
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10013801
    E.1.2Term Duchenne muscular dystrophy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of multiple ascending oral doses of vamorolone in ambulant boys ages 4-< 7 years with DMD
    E.2.2Secondary objectives of the trial
    1. To investigate the single-dose and multiple-dose pharmacokinetics (PK) of oral vamorolone at multiple dose levels in ambulant boys ages 4-< 7 years with DMD;
    2. To investigate the effects of single and multiple oral doses of vamorolone on serum pharmacodynamic (PD) biomarkers in ambulant boys ages 4-< 7 years with DMD;
    3. To evaluate metabolites of vamorolone in Metabolites in Safety Testing (MIST) assessments following administration of multiple ascending oral doses.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant’s parent or legal guardian has provided written informed consent/Health Insurance Portability and
    Accountability Act (HIPAA)authorization prior to any study-related procedures;
    2. Participant has a confirmed (by Central Genetic Counselor) diagnosis of DMD as defined as:
    a) Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin deficiency, and clinical picture
    consistent with typical DMD, OR
    b) Identifiable mutation within the DMD gene (deletion/duplication of one or more exons), where reading frame can be
    predicted as 'out-of-frame', and clinical picture consistent with typical DMD, OR
    c) Complete dystrophin gene sequencing showing an alteration (point mutation, duplication, other) that is expected to
    preclude production of the dystrophin protein (i.e. nonsense mutation, deletion/duplication leading to a downstream
    stop codon), with a typical clinical picture of DMD;
    Participant is ≥ 4 years and < 7 years of age at time of enrollment in the study;
    4. Participant is able to complete the Time to Stand Test (TTSTAND) without assistance, as assessed at the Screening
    or and Baseline Visits;
    5. Clinical laboratory test results are within the normal range at the Screening Visit, or if abnormal, are not clinically
    significant, in the opinion of the Investigator. (Note: Serum gamma glutamyl transferase [GGT], creatinine, and total
    bilirubin all must be ≤ upper limit of the normal range at the Screening Visit);
    6.Participant has evidence of chicken pox immunity as determined by presence of IgG antibodies to varicella, as
    documented by a positive test result from the testing laboratory at the Screening Visit; and
    7. Participant and caregiver are willing and able to comply with scheduled visits, study drug administration plan, and
    study procedures.
    E.4Principal exclusion criteria
    1. Participant has current or history of major renal or hepatic impairment, diabetes mellitus or immunosuppression;
    2. Participant has current or history of chronic systemic fungal or viral infections;
    3. Participant has had an acute illness within 4 weeks prior to the first dose of study medication;
    4. Participant has used mineralocorticoid receptor agents, such as spironolactone, eplerenone, canrenone
    (canrenoate potassium), prorenone (prorenoate potassium), mexrenone (mexrenoate potassium) within 4 weeks
    prior to the first dose of study medication;
    5. Participant has evidence of symptomatic cardiomyopathy [Note: Asymptomatic cardiac abnormality on investigation would not be exclusionary];
    6. Participant is currently being treated or has received previous treatment with oral glucocorticoids or other
    immunosuppressive agents [Notes: Past transient use of oral glucocorticoids or other oral immunosuppressive
    agents for no longer than 3 months cumulative, with last use at least 3 months prior to first dose of study medication,
    will be considered for eligibility on a case-by-case basis. Inhaled and/or topical corticosteroids prescribed for an
    indication other than DMD are permitted but must be administered at stable dose for at least 3 months prior to study
    drug administration];
    7. Participant has used idebenone within 4 weeks prior to the first dose of study medication;
    8. Participant has an allergy or hypersensitivity to the study medication or to any of its constituents;
    9. Participant has severe behavioral or cognitive problems that preclude participation in the study, in the opinion of the
    Investigator;
    10.Participant has previous or ongoing medical condition, medical history, physical findings or laboratory
    abnormalities that could affect safety, make it unlikely that treatment and follow-up will be correctly completed or impair
    the assessment of study results, in the opinion of the Investigator;
    11.Participant is taking any other investigational drug currently or has taken any other investigational drug within 3
    months prior to the start of study treatment; or
    12.Participant has previously been enrolled in the study.
    Note: Any parameter/test may be repeated at the Investigator's
    discretion during Screening and/or Day 1 to determine sustainability
    and reproducibility. In addition, subjects may be rescreened if ineligible
    due to a transient condition which would prevent the subject from participating, such as an upper respiratory tract infection, or if ineligible
    due to negative anti-varicella IgG antibody test result.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Endpoints
    1. Treatment-emergent adverse events (TEAEs) and serious adverse
    events (SAEs), by system organ class (SOC): overall by treatment, by
    treatment and relationship, by treatment and outcome, and by treatment
    and intensity (Common Terminology Criteria for Adverse Events [CTCAE]
    grade);
    2. Vital sign [supine blood pressure (BP), heart rate, respiratory rate,
    oral temperature] values: change from Pretreatment to each of the
    scheduled on-treatment and post-treatment assessment time points;
    3. Body weight: change from Pretreatment to each of the scheduled ontreatment
    and post-treatment assessment time points;
    4. Clinical laboratory values: change from Pretreatment to each of the
    scheduled on-treatment and post-treatment assessment time points in:
    - Hematology and biochemistry
    - Lipid profile (triglycerides, total cholesterol, low density lipoprotein
    [LDL], high density lipoprotein [HDL])
    - Urinalysis (urine protein and glucose);
    5. Concentrations of serum metabolites of vamorolone;
    6. 12-lead electrocardiogram (ECG) results: change from Pretreatment to
    Day 14 and Day 28; and
    7. Physical examination findings of abnormality.
    E.5.1.1Timepoint(s) of evaluation of this end point
    See E.5.1
    E.5.2Secondary end point(s)
    Pharmacodynamic Endpoints
    1. Concentration of acute and chronic serum PD biomarkers (change
    from Pretreatment to on-treatment and post-treatment time points):
    osteocalcin, serum aminoterminal propeptide of type I collagen (P1NP),
    carboxy-terminal telopeptide (CTX), cortisol, ACTH, 17-
    hydroxyprogesterone, testosterone, corticosterone, and 11-
    deoxycortisol, insulin, and glucose and SomaScan and proteomics
    profiling.
    Exploratory Clinical Efficacy Endpoints
    All exploratory clinical efficacy measures are assessed as change from
    Pretreatment to each of the scheduled on-treatment and post-treatment
    assessment time points:
    1. Quantitative Muscle Testing (QMT): unilateral elbow and knee muscle
    flexion and extension;
    2. Time to Stand Test (TTSTAND) from a supine position;
    3. Time to Climb 4 Steps Test (TTCLIMB);
    4. Time to Run/Walk 10 meters Test (TTRW);
    5. North Star Ambulatory Assessment (NSAA); and
    6. Six-minute Walk Test (6MWT).
    Acceptability of vamorolone by a 5-point hedonic scale. Assessed ontreatment
    and post-treatment assessment time points
    Pharmacokinetic Endpoints
    Plasma PK parameters derived from serial blood samples collected 0.5
    hour pre-dose and 1, 2, 4, 6, and 8 hours after the first and final doses of study drug on Day 1 and Day 14.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See E.5.2
    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 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 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 Yes
    E.8.1.7.1Other trial design description
    Multiple ascending dose
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    Canada
    Israel
    United States
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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 Yes
    F.1.1Number of subjects for this age range: 48
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 48
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 48
    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)
    Subjects who complete the 2-week Follow-up Period will be given the
    option of continuing vamorolone treatment in an extension study under
    separate protocol.
    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 Decision2017-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-01
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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
    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.

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