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    Summary
    EudraCT Number:2017-000684-33
    Sponsor's Protocol Code Number:OC5-DB-02
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-07
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-000684-33
    A.3Full title of the trial
    A phase III double-blind, randomized study to evaluate the long-term
    efficacy and safety of Oxabact® in patients with primary hyperoxaluria
    Estudio aleatorizado, de doble ciego, en fase III para evaluar la eficacia y seguridad a largo plazo de Oxabact® en pacientes con hiperoxaluria primaria.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to find out of if Oxabact is an effective and safe treatment for patients with primary hyperoxaluria compared to placebo
    Un estudio para averiguar si Oxabact es un tratamiento eficaz y seguro para pacientes con hiperoxaluria primaria comparado con placebo
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberOC5-DB-02
    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 SponsorOxThera Intellectual Property AB
    B.1.3.4CountrySweden
    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 supportOxThera Intellectual Property AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOxThera Intellectual Property AB
    B.5.2Functional name of contact pointDirector of Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressSturegatan 56
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post codeSE-114 36
    B.5.3.4CountrySweden
    B.5.4Telephone number004686600223
    B.5.6E-mailanna.sjogren@oxthera.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/3/06 354 and EMA/OD/095/05
    D.3 Description of the IMP
    D.3.1Product nameOxabact_Oxalobacter formigenes strain HC-1
    D.3.2Product code OC5 (enteric coated capsules)
    D.3.4Pharmaceutical form Gastro-resistant capsule, hard
    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 INNOxabacter formigenes, strain HC1
    D.3.9.3Other descriptive nameOXALOBACTER FORMIGENES, STRAIN HC 1
    D.3.9.4EV Substance CodeSUB31050
    D.3.10 Strength
    D.3.10.1Concentration unit million CFU million colony forming units
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number103
    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 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 typelive bacteria (natural, commensal, intestinal bacteria) - Oxalobacter formigenes
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGastro-resistant capsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Hyperoxaluria (PH)
    Hiperoxaluria primaria (HP)
    E.1.1.1Medical condition in easily understood language
    PH is a genetic disease associated with high levels of oxalate in the blood, the urine and throughout the body. The high oxalate levels damage the body in different ways (e.g. kidney stones)
    PH es una enfermedad genética asociada a altos niveles de oxalato en la sangre, orina y en todo el cuerpo. Los altos niveles de oxalato dañan el cuerpo de diferentes maneras (por ej, cálculos renales)
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020702
    E.1.2Term Hyperoxalemia
    E.1.2System Organ Class 100000004861
    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 efficacy of Oxabact® following 52 weeks treatment in
    patients with maintained kidney function, but below the lower limit of the normal range (eGFR < 90 ml/min/1.73 m2) and a total plasma oxalate concentration ≥ 10 μmol/L at baseline
    Evaluar la eficacia de Oxabact® después de 52 semanas de tratamiento en pacientes que conservan la función renal, aunque por debajo del límite inferior del intervalo normal (TFGe < 90 ml/min/1,73 m2) y una concentración plasmática total de oxalato ≥ 10 μmol/l al inicio.
    E.2.2Secondary objectives of the trial
    To obtain additional safety data from 52 weeks continuous treatment
    with Oxabact®
    Obtener datos de seguridad adicionales del tratamiento continuo con Oxabact® durante 52 semanas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent (as applicable for the age of the subject).
    2. A diagnosis of PH (as determined by standard diagnostic methods).
    3. eGFR < 90 ml/min/1.73 m2. The Schwartz formula will be used to estimate GFR for children (age below 18), and CKD-EPI formula will be used for adults (age 18 or above).
    4. Plasma oxalate concentration ≥10 μmol/L in total plasma oxalate.
    5. Male or female patients ≥ 2 years of age.
    6. Patients receiving vitamin B6 must be receiving a stable dose for at least 3 months prior to screening and must not change the dose during the study. Patients not receiving vitamin B6 at study entry must be willing to refrain from initiating pyridoxine during study participation.
    1. Consentimiento informado firmado (según corresponda a la edad del paciente).
    2. Diagnóstico de HP (según se determine por métodos de diagnóstico estándar).
    3. TFGe < 90 ml/min/1,73 m2. Se usará la fórmula de Schwartz para calcular la TFGe en niños (menores de 18), y se usará la fórmula CKD-EPI para adultos (con 18 años o más).
    4. Concentración de oxalato plasmático ≥10 μmol/l en oxalato plasmático total.
    5. Pacientes: varones o mujeres, ≥ 2 años de edad.
    6. Los pacientes que reciban vitamina B6 deben tomar una dosis estable al menos durante los 3 meses previos a la selección y no deben modificar la dosis durante el estudio. Los pacientes que no reciban vitamina B6 en el momento de entrar al estudio deben abstenerse de empezar a tomar piridoxina durante su participación en el estudio.
    E.4Principal exclusion criteria
    7. Inability to swallow size 4 capsules.
    8. Subjects that have undergone transplantation (solid organ or bone marrow).
    9. Patients requiring dialysis or at immediate risk for kidney failure or expected to be in need of dialysis during the study period.
    10. The existence of secondary hyperoxaluria, e.g. hyperoxaluria due to bariatric surgery or chronic gastrointestinal diseases such as cystic fibrosis, chronic inflammatory bowel disease and short-bowel syndrome.
    11. Use of antibiotics to which O. formigenes is sensitive, including current antibiotic use, or antibiotics use within 14 days of initiating study medication.
    12. Current treatment with a separate ascorbic acid preparation.
    13. Pregnant women (or women who are planning to become pregnant) or lactating women.
    14. Women of childbearing potential who are not using adequate contraceptive precautions. Please see section 7.3 regarding requirements for contraception.
    15. Presence of a medical condition that the Investigator considers likely to make the subject susceptible to adverse effect of study treatment or unable to follow study procedures or any condition that is likely to interfere with the study drug mechanism of action (such as abnormal GI function).
    16. Participation in any interventional study of another investigational product, biologic, device, or other agent within 60 days prior to the first dose of OC5 or not willing to forego other forms of investigational treatment during this study.
    7. Incapacidad para tragar cápsulas de tamaño 4.
    8. Los pacientes que se hayan sometido a un trasplante (de un órgano sólido o médula ósea).
    9. Los pacientes que requieran diálisis o se encuentren en riesgo inmediato de insuficiencia renal o se prevé que necesiten diálisis durante el transcurso del período del estudio.
    10. La existencia de hiperoxaluria secundaria, p. ej., hiperoxaluria a causa de una cirugía bariátrica o enfermedades gastrointestinales crónicas, como fibrosis quística, enfermedad inflamatoria intestinal crónica y síndrome de intestino corto.
    11. El uso de antibióticos a los cuales O. formigenes es sensible, entre ellos el uso del antibiótico actual, o antibióticos dentro de los 14 días tras iniciado el medicamento del estudio.
    12. Tratamiento actual con un preparado independiente de ácido ascórbico.
    13. Mujeres embarazadas (o mujeres que estén planeando quedarse embarazadas) o madres en periodo de lactancia.
    14. Las mujeres en edad fértil que no estén tomando medidas anticonceptivas adecuadas. Consulte la sección 7.3 respecto a los requisitos de anticoncepción.
    15. La presencia de una afección médica que, a criterio del Investigador, vuelva al sujeto susceptible a un efecto adverso procedente del tratamiento del estudio, o bien sea incapaz de seguir los procedimientos del estudio, o cualquier afección que probablemente interfiera con el mecanismo de acción del medicamento del estudio (como función GI anormal).
    16. La participación en cualquier estudio de intervención de otro producto en investigación, dispositivo, sustancia biológica u otro agente dentro de los 60 días previos a la primera dosis de OC5, o la falta de voluntad de continuar con otras formas de tratamiento de investigación durante este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in plasma oxalate concentration after 52 weeks of treatment (total plasma oxalate concentration).
    Cambio a partir del valor inicial en la concentración plasmática de oxalato después de 52 semanas de tratamiento (concentración plasmática total de oxalato).
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 52 weeks of treatment
    Después de 52 semanas de tratamiento.
    E.5.2Secondary end point(s)
    1. Change from baseline in plasma oxalate concentration (total plasma oxalate concentration)after 52 weeks of treatment in different subgroups of patients:
    • Patients with a baseline urinary oxalate excretion above and below
    1.87 mmol/L/24h/1.73 m2 respectively (mean of the two first values during screening/baseline).
    • Patients above and below 18 years of age.
    • Patients with a baseline eGFR above and below 60 ml/min/1.73m2 respectively (mean of the obtained values during screening/baseline calculated by the Schwartz/CKD-EPI equation).
    2. Change from baseline in kidney function (eGFR) after 52 weeks of treatment.
    3. Change from baseline in kidney function (eGFR) after 52 weeks of treatment in different subgroups of patients:
    • Patients with a baseline urinary oxalate excretion above and below
    1.87 mmol/L/24h/1.73 m2 respectively (mean of the two values during screening/baseline).
    • Patients above and below 18 years of age.
    • Patients with a baseline eGFR above and below 60 ml/min/1.73m2 respectively (mean of the obtained values during screening/baseline calculated by the Schwartz/CKD-EPI equation).
    4. Change from baseline in myocardial function in the heart as measured by Speckle Tracking Echocardiography (STE).
    5. Change from baseline in score of Quality of Life questionnaire.
    6. Change from baseline in free plasma oxalate concentration after 52 weeks of treatment.
    7. Change from baseline in free plasma oxalate concentration after 52 weeks of treatment in different subgroups of patients:
    • Patients with a baseline urinary oxalate excretion above and below 1.87 mmol/L/24h/1.73 m2 respectively (mean of the two first values during screening/baseline).
    • Patients above and below 18 years of age.
    • Patients with a baseline eGFR above and below 60 ml/min/1.73m2 respectively (mean of the obtained values during screening/baseline calculated by the Schwartz/CKD-EPI equation.
    Safety:
    Adverse events (AEs), vital signs, physical examination, hematology, clinical chemistry, urinalysis.
    1. Cambio a partir del valor inicial en la concentración plasmática de oxalato (concentración plasmática total de oxalato) después de 52 semanas de tratamiento en diferentes subgrupos de pacientes:
    - Pacientes con una eliminación urinaria inicial en oxalato superior e inferior a 1,87 mmol/l/24h/1,73 m2 respectivamente (media de los dos primeros valores durante la selección/momento inicial).
    - Pacientes mayores y menores de 18 años de edad.
    - Pacientes con TFGe inicial superior e inferior a 60 ml/min/1,73 m2 respectivamente (media de los valores obtenidos durante la selección/momento inicial y calculada con la ecuación Schwartz/CKD-EPI).

    2. Cambio a partir del valor inicial en la función renal (TFGe) después de 52 semanas de tratamiento.

    3. Cambio a partir del valor inicial en la función renal (TFGe) después de 52 semanas de tratamiento en diferentes subgrupos de pacientes:
    - Pacientes con eliminación urinaria inicial de oxalato superior e inferior a 1,87 mmol/l/24h/1,73 m2 respectivamente (media de los dos valores durante la selección/momento inicial).
    - Pacientes mayores y menores de 18 años de edad.
    - Pacientes con TFGe inicial superior e inferior a 60 ml/min/1,73 m2 respectivamente (media de los valores obtenidos durante la selección/momento inicial y calculada con la ecuación Schwartz/CKD-EPI).

    4. Cambio a partir del valor inicial en la función miocárdica del corazón medida mediante ecocardiografía con rastreo de marcas.

    5. Cambio a partir del valor inicial en la puntuación del cuestionario referido a la Calidad de vida.

    6. Cambio a partir del valor inicial en la concentración plasmática libre de oxalato después de 52 semanas de tratamiento.

    7. Cambio a partir del valor inicial en la concentración plasmática libre de oxalato después de 52 semanas de tratamiento en diferentes subgrupos de pacientes:
    - Pacientes con una eliminación urinaria inicial en oxalato superior e inferior a 1,87 mmol/l/24h/1,73 m2 respectivamente (media de los dos primeros valores durante la selección/momento inicial).
    - Pacientes mayores y menores de 18 años de edad.
    - Pacientes con TFGe inicial superior e inferior a 60 ml/min/1,73 m2 respectivamente (media de los valores obtenidos durante la selección/momento inicial calculada con la ecuación Schwartz/CKD-EPI).
    Seguridad:
    Eventos adversos (EA), constantes vitales, exploración física, hematología, química clínica, análisis de orina.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. after 52 weeks of treatment
    2. after 52 weeks of treatment
    3. after 52 weeks of treatment
    4. STEs are measured twice during the baseline period and the mean is compared to the results after 24 and 48 weeks of treatment.
    5. Questionnaires are taken twice during baseline and and the mean is compared to the results of Day 0 and week 8, 18, 24, 32, 40, 48 and 52.
    1. Después de 52 semanas de tratamiento.
    2. Después de 52 semanas de tratamiento.
    3. Después de 52 semanas de tratamiento.
    4. STEs se miden dos veces durante el período basal y la media se compara con los resultados después de 24 y 48 semanas de tratamiento.
    5. Los cuestionarios se toman dos veces durante el período basal y la media se compara con los resultados del día 0 y la semana 8, 18, 24, 32, 40, 48 y 52.
    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 No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 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 EEA8
    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
    France
    Germany
    Netherlands
    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
    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 Yes
    F.1.1Number of subjects for this age range: 12
    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: 6
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 6
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 6
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children are recruited for this study. Informed Consent will be obtained from their parents or legal guardians as appropriate
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 18
    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)
    The patients will be offered to continue in an open-label follow-up
    protocol with Oxabact® treatment directly after the 52 weeks treatment period.
    Se ofrecerá a los pacientes que continúen en un seguimiento abierto con tratamiento de Oxabact® directamente después de las 52 semanas de tratamiento.
    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 Decision2018-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-04-15
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