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    Summary
    EudraCT Number:2017-004268-36
    Sponsor's Protocol Code Number:APL2-302
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-08-07
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-004268-36
    A.3Full title of the trial
    A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Estudio de fase III, controlado, aleatorizado, multicéntrico, abierto y con comparador activo para evaluar la eficacia y seguridad de APL-2 en pacientes con hemoglobinuria paroxística nocturna (HPN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug APL-2 In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres.
    Un estudio de investigación para recopilar información científica sobre la eficacia, seguridad y tolerabilidad del fármaco en investigación APL-2 en el tratamiento de pacientes con hemoglobinuria paroxística nocturna (HPN), una enfermedad asociada con anemia, en una comparación asignada aleatoriamente en múltiples centros de investigación con el tratamiento estándar actual aprobado para HPN .
    A.3.2Name or abbreviated title of the trial where available
    PEGASUS
    A.4.1Sponsor's protocol code numberAPL2-302
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03500549
    A.5.4Other Identifiers
    Name:US IND NumberNumber:123087
    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 SponsorApellis Pharmaceuticals, 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 supportApellis Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiorasi GmbH
    B.5.2Functional name of contact pointEuropean Project Operations
    B.5.3 Address:
    B.5.3.1Street AddressNiermannsweg 11-15
    B.5.3.2Town/ cityErkrath
    B.5.3.3Post code40699
    B.5.3.4CountryGermany
    B.5.4Telephone number+4915786389996
    B.5.5Fax number+4921125033233
    B.5.6E-mailhschmied@biorasi.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/3/17/1873
    D.3 Description of the IMP
    D.3.1Product nameAPL-2
    D.3.2Product code APL-2
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNn/a
    D.3.9.1CAS number n/a
    D.3.9.2Current sponsor codeAPL-2
    D.3.9.3Other descriptive namen/a
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number54
    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 Yes
    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 Soliris
    D.2.1.1.2Name of the Marketing Authorisation holderAlexion Europe SAS
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1304
    D.3 Description of the IMP
    D.3.1Product nameSoliris
    D.3.4Pharmaceutical form 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 INNECULIZUMAB
    D.3.9.1CAS number 219685-50-4
    D.3.9.4EV Substance CodeSUB25187
    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) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    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
    PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.
    PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation.
    E.1.1.1Medical condition in easily understood language
    PNH is a rare disorder causing red blood cells to break down too early. Patients may still suffer from anemia even when treated with standard of care.
    La HPN es un trastorno poco frecuente que hace que los glóbulos rojos se descompongan demasiado pronto. Los pacientes aún pueden sufrir de anemia incluso cuando reciben tratamiento estándar.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10055629
    E.1.2Term Paroxysmal nocturnal hemoglobinuria
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of this study are to establish the efficacy and safety of APL-2 compared to eculizumab in patients with PNH who continue to have Hb levels <10.5 g/dL despite treatment with eculizumab.
    Los objetivos principales de este estudio son establecer la eficacia y la seguridad del APL-2 comparado con el eculizumab en pacientes con HPN cuyas concentraciones de Hb continúan siendo <10,5 g/dl a pesar del tratamiento con eculizumab.
    E.2.2Secondary objectives of the trial
    not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.At least 18 years of age
    2.Primary diagnosis of PNH confirmed by high-sensitivity flow cytometry
    3.On treatment with eculizumab. Dose of eculizumab must have been stable for at least 3 months prior to the Screening Visit
    4.Hb <10.5 g/dL at the Screening Visit
    5.Absolute reticulocyte count > 1.5x ULN at the Screening Visit
    6.Platelet count of >50,000/mm3 at the Screening Visit
    7.Absolute neutrophil count >500/mm3 at the Screening Visit
    8.Vaccination against Neisseria meningitides types A, C, W, Y and B, Streptococcus pneumoniae and Haemophilus influenzae Type B (Hib) either within 2 years prior to Day 1 dosing, or within 14 days after starting treatment with APL-2. Unless documented evidence exists that subjects are non-responders to vaccination as evidenced by titers or display titer levels within acceptable local limits
    9.Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the Screening and Day -28 Visit (Run-in Period) and must agree to use protocol defined methods of contraception for the duration of the study and 60 days after their last dose of study drug
    10.Males must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study and 60 days after their last dose of study drug
    11.Willing and able to give informed consent
    12.Willing and able to self-administer APL-2 (administration by caregiver will be allowed)
    1. 18 años de edad como mínimo
    2. Diagnóstico principal de HPN confirmado mediante citometría de flujo con alta sensibilidad
    3. En tratamiento con eculizumab. La dosis de eculizumab debe haberse mantenido estable durante 3 meses como mínimo antes de la Visita de selección
    4. Hb <10,5 g/dl en la Visita de selección
    5. Recuento absoluto de reticulocitos >1,5 x LSN en la Visita de selección
    6. Recuento de plaquetas >50.000/mm3 en la Visita de selección
    7. Recuento absoluto de neutrófilos >500/mm3 en la Visita de selección
    8. Vacunación frente a Neisseria meningitides de tipos A, C, W, Y B, Streptococcus pneumoniae y Haemophilus influenzae de tipo B (Hib) en los 2 años anteriores a la dosis del Día 1, o en los 14 días posteriores al comienzo del tratamiento con APL-2. A menos que se disponga de pruebas documentadas de que los sujetos no responden a las vacunas como demuestran los títulos o niveles de títulos dentro de límites aceptables localmente
    9. Las mujeres en edad fértil deberán presentar una prueba de embarazo negativa en la Visita de selección y la visita del Día -28 (período de preinclusión), y deberán acordar usar los métodos anticonceptivos definidos en el protocolo durante todo el estudio y 60 días después de la última dosis del fármaco del estudio
    10. Los hombres deberán acordar usar los métodos anticonceptivos definidos en el protocolo y abstenerse de donar esperma durante todo el estudio y 60 días después de su última dosis del fármaco del estudio
    11. Deseo y capacidad para otorgar el consentimiento informado
    12. Deseo y capacidad para autoadministrarse el APL-2 (se permite la administración por el cuidador)
    E.4Principal exclusion criteria
    1.Active bacterial infection within 4 weeks prior to Day -28 (Run-in Period)
    2.Receiving iron, folic acid, vitamin B12 and EPO, unless the dose is stable, in the 4 weeks prior to Screening
    3.Hereditary complement deficiency
    4.History of bone marrow transplantation
    5.History or presence of hypersensitivity or idiosyncratic reaction to compounds related to the investigational product of SC administration
    6.Participation in any other investigational drug trial or exposure to other investigational agent within 30 days or 5 half-lives (whichever is longer)
    7.Currently breast-feeding women
    8.Inability to cooperate or any condition that, in the opinion of the investigator, could increase the subject's risk of participating in the study or confound the outcome of the study
    9.History or family history of Long QT Syndrome or torsade de pointes, unexplained syncope, syncope from an uncorrected cardiac etiology, or family history of sudden death
    10.Myocardial infarction, CABG, coronary or cerebral artery stenting and /or angioplasty, stroke, cardiac surgery, or hospitalization for congestive heart failure within 3 months or > Class 2 Angina Pectoris or NYHA Heart Failure Class >2
    11.QTcF > 470 ms, PR > 280 ms
    12.Mobitz II 2nd degree AV Block, 2:1 AV Block, High Grade AV Block, or Complete Heart Block unless the patient has an implanted pacemaker or implantable cardiac defibrillator (ICD) with backup pacing capabilities
    13.Receiving Class 1 or Class 3 antiarrhythmic agents, or arsenic, methadone, ondansetron or pentamidine at screening
    14.Receiving any other QTc-prolonging drugs, at a stable dose for less than 3 weeks prior to dosing
    15.Receiving prophylactic ciprofloxacin, erythromycin or azithromycin for less than one week prior to the first dose of study medication (must have a repeat screening ECG after one week of prophylactic antibiotics with QTcF < 470 ms)
    1. Infección bacteriana activa en el periodo de 4 semanas anterior al Día -28 (período de preinclusión)
    2. Haber tomado hierro, ácido fólico, vitamina B12 o EPO, a menos que la dosis sea estable, durante las 4 semanas anteriores a la Visita de Selección
    3. Deficiencia hereditaria de complemento
    4. Antecedentes de trasplante de médula ósea
    5. Antecedentes de hipersensibilidad o reacción idiosincrática a compuestos relacionados con el producto en investigación o a la administración s.c.
    6. Participación en cualquier otro ensayo de fármacos en investigación o exposición a otros fármacos en investigación en los 30 días o 5 semividas anteriores (lo que sea más largo)
    7. Mujeres que actualmente están amamantando
    8. Incapacidad para cooperar o cualquier patología que, en opinión del investigador, pudiera aumentar el riesgo de la participación del sujeto en el estudio o afectar a los resultados del estudio
    9. Antecedentes personales o familiares de síndrome de QT prolongado o torsade de pointes, síncope inexplicado, síncope debido a una causa cardíaca no corregida o antecedentes familiares de muerte súbita
    10. Infarto de miocardio, revascularización aortocoronaria (RVC), stent y/o angioplastia en arteria coronaria o cerebral, accidente cerebrovascular, cirugía cardíaca hospitalización por insuficiencia coronaria congestiva en los tres meses anteriores o angina de pecho o insuficiencia cardíaca de clase >2 según la clasificación de la New York Heart Association (NYHA)
    11. QTcF >470 ms, PR >280 ms
    12. Bloqueo AV de 2.º grado Mobitz II, bloqueo AV 2:1, bloqueo AV de grado alto o bloqueo completo, a menos que el paciente lleve implantado un marcapasos o defibrilador cardíaco implantable (DCI) con capacidad de regulación del ritmo
    13. Estar tomando fármacos antiarrítmicos clase 1 o clase 3, o arsénico, metadona, ondansetrón o pentamidina en la fecha de la selección
    14. Haber tomado otros fármacos que prolongan el QTc (ver Apéndice 4 en Sección 18.4) a una dosis estable menos de 3 semanas antes de la dosificación
    15. Haber tomado ciprofloxacino, eritromicina o azitromicina profilácticas menos de una semana antes de la primera dosis de la medicación en estudio (el ECG de selección se debe repetir tras una semana de antibióticos profilácticos con QTcF < 470 ms)
    E.5 End points
    E.5.1Primary end point(s)
    Week 16 change from baseline in hemoglobin level
    Cambio medio desde el inicio hasta la Semana 16 en la concentración de hemoglobina
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16 of randomized controlled treatment
    Semana 16 de tratamiento controlado aleatorizado
    E.5.2Secondary end point(s)
    •Week 16 change from baseline in reticulocyte count
    •Week 16 change from baseline in lactate dehydrogenase (LDH) level
    •Week 16 change from baseline in FACIT-fatigue scale score
    •Number of PRBC units transfused from Week 4 to Week 16 (Day 28 to Day 112)
    •Hemoglobin response in the absence of transfusions (Yes/No). Hemoglobin response is defined as a 1g/dL increase in hemoglobin from Baseline at Week 16
    •Reticulocyte normalization in the absence of transfusions at Week 16 (Yes/No). Reticulocyte normalization is defined as the reticulocyte count being below the upper limit of the normal range
    • Cambio desde el inicio hasta la Semana 16 en el recuento de reticulocitos
    • Cambio desde el inicio hasta la Semana 16 en las concentraciones de lactato deshidrogenasa (LDH)
    • Cambio desde el inicio hasta la Semana 16 en la puntuación de la escala de fatiga FACIT
    • Número de unidades de concentrado de hematíes (CH) transfundidas desde la Semana 4 hasta la Semana 16 (Día 28 a Día 112)
    • Respuesta de la hemoglobina en ausencia de transfusiones (Sí/No). La respuesta de la hemoglobina se define como un aumento de 1 g/dl en la hemoglobina en la Semana 16 respecto al inicio.
    • Normalización de los reticulocitos en ausencia de transfusiones en la Semana 16 (Sí/No).
    • La normalización de los reticulocitos se define como recuento de reticulocitos inferior al límite superior de la normalidad.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16
    Semana 16
    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) 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Japan
    Korea, Republic of
    Russian Federation
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 70
    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)
    After completion of the 52-week treatment period (Week 48), subjects will be offered entry into an open label extension study. Should the subject not enter the open label extension study they will exit the study and return to the site for 2 additional safety visits 6 weeks apart. Subjects who withdraw from treatment prior to the Week 48 visit may continue their participation in the study and return to the study site for their scheduled study procedures, with exception of APL-2 administration.
    Tras finalizar el periodo de tratamiento de 52 semanas (Semana 48) se ofrecerá a los sujetos la posibilidad de participar en un estudio de ampliación abierto. Si el sujeto no desea participar en el estudio de ampliación abierto, abandonará el estudio y acudirá al centro para someterse a dos visitas de seguridad adicionales con un intervalo de 6 semanas.
    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 Decision2018-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-25
    P. End of Trial
    P.End of Trial StatusOngoing
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