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    Summary
    EudraCT Number:2018-003576-12
    Sponsor's Protocol Code Number:OC5-OL-02
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-06-11
    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 number2018-003576-12
    A.3Full title of the trial
    An open-label single-arm treatment extension study to evaluate the long-term efficacy and safety of Oxabact® for patients with primary hyperoxaluria who completed study OC5-DB-02
    Estudio de ampliación del tratamiento, con un solo grupo y sin enmascaramiento para evaluar la seguridad y la eficacia a largo plazo de Oxabact® en pacientes con hiperoxaluria primaria y que han completado el estudio OC5-DB-02.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to confirm that Oxabact® is an effective and safe treatment for patients with primary hyperoxaluria
    Un estudio para confirmar que Oxabact® es un tratamiento eficaz y seguro para pacientes con hiperoxaluria primaria
    A.3.2Name or abbreviated title of the trial where available
    ePHex OLE
    A.4.1Sponsor's protocol code numberOC5-OL-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 pointChief Operating Officer
    B.5.3 Address:
    B.5.3.1Street Addressc/o Klara Papper, Box 1062
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post codeSE-10139
    B.5.3.4CountrySweden
    B.5.4Telephone number004686600223
    B.5.6E-mailelisabeth.lindner@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 INNOXALOBACTER FORMIGENES, STRAIN HC 1
    D.3.9.2Current sponsor codeOC5
    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 number1000
    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
    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 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 formas(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 20.1
    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 two years continued treatment in subjects who have completed the Oxabact® OC5-DB-02 study.
    Evaluar la eficacia de Oxabact® después de dos años de tratamiento continuo en pacientes que han completado el estudio OC5-DB-02 con Oxabact®.
    E.2.2Secondary objectives of the trial
    To obtain additional safety data from two years continuous treatment with Oxabact®.
    Obtener datos de seguridad adicionales del tratamiento continuo durante dos años con Oxabact®.
    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. Participation in and completion of study OC5-DB-02.
    3. Subjects who had received vitamin B6 during OC5-DB-02 should maintain a stable dose. Subjects not receiving vitamin B6 during OC5-DB-02 must be willing to refrain from initiating pyridoxine during study participation.
    1. Consentimiento informado firmado (según corresponda a la edad del paciente).
    2. Participación y finalización del estudio OC5-DB-02.
    3. Los pacientes que hayan recibido vitamina B6 durante OC5-DB-02 deberán mantener una dosis estable. Los pacientes que no hayan recibido vitamina B6 durante OC5-DB-02 deberán abstenerse de empezar a tomar piridoxina durante su participación en el estudio.
    E.4Principal exclusion criteria
    4. Inability to swallow size 4 capsules.
    5. Use of antibiotics to which O. formigenes is sensitive.
    6. Current treatment with a separate ascorbic acid preparation.
    7. Pregnant women (or women who are planning to become pregnant).
    8. Women of childbearing potential who are not using adequate contraceptive precautions.
    9. 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).
    10. Participation in any interventional study of another investigational product, biologic, device, or other agent or not willing to forego other forms of investigational treatment during this study.
    4. Incapacidad para tragar cápsulas de tamaño 4.
    5. Uso de antibióticos a los cuales sea sensible O. formigenes.
    6. Tratamiento actual con un preparado independiente de ácido ascórbico.
    7. Mujeres embarazadas (o mujeres que estén planeando quedarse embarazadas).
    8. Las mujeres en edad fértil que no estén tomando medidas anticonceptivas adecuadas.
    9. La presencia de una afección médica que, a criterio del Investigador, vuelva al paciente susceptible a un efecto adverso procedente del tratamiento del estudio, o bien le haga incapaz de seguir los procedimientos del estudio, o padezca cualquier afección que probablemente interfiera con el mecanismo de acción del medicamento del estudio (como función GI anormal).
    10. La participación en cualquier estudio de intervención de otro producto en investigación, dispositivo, sustancia biológica u otro agente o su 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 kidney function (eGFR)
    Cambio a partir del valor inicial en la función renal (TFGe)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 12 and 24 months of open-label Oxabact® treatment
    Después de 12 y 24 meses de tratamiento sin enmascaramiento con Oxabact®
    E.5.2Secondary end point(s)
    Key secondary endpoints:
    1. Change from baseline in total plasma oxalate concentration.
    2. Frequency of kidney stones events. Stone events are defined as: (i) Subject- or investigator-reported symptoms, or (ii) Stone passages or removals, or (iii) Increase in the number of kidney stones as assessed by ultrasound.

    Other endpoints:
    3. Change from baseline in myocardial function as measured by Speckle Tracking and traditional echocardiography.
    4. Change from baseline in free plasma oxalate concentration.
    5. Change from baseline in urinary oxalate.
    6. Change from baseline in grade of nephrocalcinosis as assessed by ultrasound.
    7. Change in number of O. formigenes in stool.
    8. Correlation between change in number of O. formigenes in stool and change in total plasma oxalate concentration.
    9. Change from baseline in score of Quality of Life questionnaire.
    10. Change from baseline in markers for renal tubular capacity and inflammation: Urine: magnesium, phosphorus, citrate, calcium, glycolate, creatinine, urea, calcium oxalate crystals, pH, osmolality and urinary volume. Blood: magnesium, phosphorus, citrate, calcium, glycolate, BUN, ALP, bicarbonate, CRP, WBC, creatinine and cystatine C.
    Criterios secundarios de valoración:
    1.Cambio a partir del valor inicial en la concentración plasmática total de oxalato
    2.Frecuencia de episodios de nefrolitiasis. Los episodios de nefrolitiasis se definen como: (i) Síntomas notificados por el investigador o el paciente, o bien (ii) expulsión en micciones o extracciones de cálculos; o bien
    (iii) aumento en el número de cálculos detectados mediante ecografía.

    Otros criterios de valoración
    3.Cambio a partir del valor inicial en la función miocárdica medida mediante ecocardiografía con rastreo de marcas y tradicional
    4.Cambio a partir del valor inicial en la concentración plasmática de oxalato libre
    5.Cambio a partir del valor inicial en la eliminación urinaria de oxalato
    6.Cambio a partir del valor inicial en el grado de nefrocalcinosis detectado mediante ecografía
    7.Cambio en la cantidad de O. formigenes en las heces
    8.Correlación entre el cambio en la cantidad de O. formigenes en heces y el cambio en la concentración plasmática total de oxalato.
    9.Cambio a partir del valor inicial en la puntuación del cuestionario referido a la Calidad de vida.
    10.Cambio a partir del valor inicial en los marcadores de inflamación y capacidad tubular renal:Orina: magnesio, fósforo, citrato, calcio, glicolato, creatinina, urea, cristales de oxalato cálcico, pH, osmolaridad y volumen urinario.Sangre: magnesio, fósforo, citrato, calcio, glicolato, BUN, ALP, pH, bicarbonato, PCR, leucocitos, creatinina y cistatina C.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 12 and 24 months of open-label Oxabact® treatment
    Después de 12 y 24 meses de tratamiento sin enmascaramiento con Oxabact®
    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 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 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
    Belgium
    France
    Germany
    Netherlands
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    E.8.9.2In all countries concerned by the trial months6
    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: 11
    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: 5
    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: 5
    F.1.3Elderly (>=65 years) No
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 16
    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)
    Revert to standard of care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-07-14
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