Multi-Food Oral Immunotherapy for Peanut and Tree Nuts
11 de agosto de 2026 actualizado por: Medical University of Warsaw
An Open-Label, Multicenter, Randomized Clinical Trial Evaluating the Efficacy and Safety of Oral Multi-Food Immunotherapy With Peanut and Tree Nuts Protein Mixtures
This study aims to evaluate the efficacy and safety of multi-food oral immunotherapy (multi-OIT) using peanut and tree nuts proteins in children with confirmed food allergy to at least two allergens.
Participants will be randomized in a 2:1 ratio to receive either multi-OIT or standard management consisting of an elimination diet.
The primary objective is to evaluate immunotherapy efficacy defined as achieving tolerance to a cumulative dose of 4444 mg of protein during an oral food challenge (OFC-2) for at least one allergen that elicited a reaction during baseline challenge (OFC-1), compared with the control group.
Secondary outcomes include the proportion of participants tolerating multiple allergens at the target cumulative dose; the incidence, type, and severity of adverse events classified according to the World Allergy Organization (WAO) grading system; changes in immunological parameters, including allergen-specific IgE and IgG4 levels; changes in skin prick test responses; changes in the quality of life of patients and their families.
Descripción general del estudio
Estado
Estado
Aún no reclutando
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
This is an interventional, open-label, multicenter, randomized clinical trial enrolling 39 children aged 1-12 years with confirmed allergy to at least two of the following allergens: peanut, cashew, walnut, hazelnut and almond.
Participants will be randomized in a 2:1 ratio to either the experimental group receiving multi-food oral immunotherapy (multi-OIT) or the control group receiving standard of care consisting of an elimination diet and rescue medications. Multi-OIT will be administered using a standardized mixture of peanut and tree nuts proteins, with a dose-escalation phase followed by a maintenance phase targeting 300 mg of protein per allergen per day. Treatment duration will be approximately 18 months.
All participants will undergo oral food challenges at baseline (OFC-1) and at the end of the study (OFC-2). The primary efficacy endpoint is defined as the proportion of participants achieving tolerance to a cumulative dose of 4444 mg of protein during OFC-2 for at least one allergen that elicited a reaction during OFC-1, compared with the control group. Safety will be monitored throughout the study based on adverse events recorded in symptom diaries and classified according to established grading systems.
Secondary outcomes include the proportion of participants tolerating multiple allergens at the target cumulative dose, the frequency and severity of adverse events classified according to the World Allergy Organization (WAO) grading system, changes in immunological parameters (including allergen-specific IgE and IgG4), skin prick test responses and quality of life of patients and their families.
Participants in the control group will be offered the option to receive immunotherapy after completion of the study.
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Estimado)
Inscripción
39
Fase
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
Estudio Contacto
- Nombre: Katarzyna Grzela, PhD, MD
- Número de teléfono: +48 22 3179417
- Correo electrónico: katarzyna.grzela@wum.edu.pl
Ubicaciones de estudio
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polonia, 60-572
- Department of Pediatric Pulmonology, Allergology and Clinical Immunology, Institute of Pediatrics, Karol Jonscher Clinical Hospital, Poznań University of Medical Sciences
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Contacto:
- Irena Wojsyk-Banaszak, MD, PhD
- Número de teléfono: +48618491313
- Correo electrónico: sekretpulmo@skp.ump.edu.pl
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polonia, 30-663
- Department of Pediatrics, Children's Diseases Clinic, Jagiellonian University Medical Colleg, Division of Pulmonology, Allergology and Dermatology, University Children's Hospital in Kraków
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Contacto:
- Ewa Cichocka-Jarosz, MD, PhD
- Número de teléfono: +48 12 333 94 77
- Correo electrónico: mijarosz@cyf-kr.edu.pl
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Masovian Voivodeship
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Dziekanów Leśny, Masovian Voivodeship, Polonia, 05-092
- Allergy Unit, Department of Pulmonary Diseases, Children's Hospital in Dziekanów Leśny
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Contacto:
- Wioletta Zagórska, MD, PhD
- Número de teléfono: +48 22 765 74 02
- Correo electrónico: wioletta.zagorska@szpitaldziekanow.pl
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Warsaw, Masovian Voivodeship, Polonia, 02-091
- Department of Paediatric Pulmonology and Allergology, Medical University of Warsaw
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Contacto:
- Katarzyna Grzela, MD, PhD
- Número de teléfono: +48 22 3179417
- Correo electrónico: katarzyna.grzela@wum.edu.pl
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age 1-12 years;
- Confirmed allergy to at least two allergens included in the protocol, i.e., peanut and/or tree nuts: cashew, walnut, hazelnut, and almond;
- Positive skin prick test (SPT) (wheal diameter ≥ 3 mm) and/or specific IgE (sIgE) level > 0.35 kUA/L for at least two of the analyzed allergens;
- Positive OFC-1 (oral food challenge) of grade I-IV according to the WAO classification for at least two allergens, with a positive reaction occurring after administration of a dose ≥ 3 mg and ≤ 3000 mg of allergen protein;
- Participants may be enrolled based on the abbreviated procedure as outlined in the study description;
- Written informed consent obtained from a legal guardian, and, where applicable, assent from the child in accordance with their age and level of maturity;
- Good prognosis for compliance and cooperation of the patient and their caregivers.
Exclusion Criteria:
- Allergic reaction at the lowest challenge dose of 1 mg of allergen protein for any allergen, or no allergic reaction after administration of the maximum dose of 3000 mg of allergen protein for at least four of the analyzed allergens;
- History of anaphylaxis with a grade V reaction according to the WAO classification, either during an oral food challenge or in the patient's medical history;
- Severe asthma;
- Poorly controlled asthma according to GINA 2025 (lack of symptom control and/or ≥2 exacerbations requiring systemic glucocorticoids or ≥1 exacerbation requiring hospitalization within the last 12 months), or in children able to perform spirometry: FEV1 < -1.64 Z-score and/or FEV1/FVC < -1.64 Z-score;
- Eosinophilic gastrointestinal disease;
- Other chronic diseases requiring ongoing treatment which, in the investigator's opinion, may increase the risk associated with study participation or interfere with the interpretation of results, including severe cardiac disease, epilepsy, metabolic disorders, or diabetes;
- Previous immunotherapy with food allergens;
- Concurrent immunotherapy with aeroallergens;
- Treatment with biologic agents, beta-blockers, ACE inhibitors, or calcium channel blockers;
- Oral corticosteroid therapy meeting any of the following criteria: daily treatment for >1 month within the last 12 months; at least two courses lasting ≥7 days within the last 12 months; one course lasting ≥7 days within the last 3 months;
- Lack of consent to participate in the study or insufficient cooperation of the patient and/or caregivers. In such cases, patients will receive standard medical care, including allergen avoidance and provision of emergency medication.
Well-controlled asthma, allergic rhinitis, and atopic dermatitis are not exclusion criteria.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
2
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: Multi-Food Oral Immunotherapy (Multi-OIT)
Participants will receive multi-food oral immunotherapy (multi-OIT) using a standardized mixture of peanut and tree nuts proteins (cashew, walnut, hazelnut, and almond).
Treatment includes a dose-escalation phase (1-300 mg protein per allergen) followed by a maintenance phase for 12 months (+/- 3 months) with a target daily dose of 300 mg of protein per allergen.
Dose increases will be performed under medical supervision, and daily dosing will be continued at home.
The total treatment duration is approximately 18 months.
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Multi-food oral immunotherapy using a standardized mixture of peanut and tree nuts proteins (cashew, walnut, hazelnut, and almond), administered in a dose-escalation phase followed by a maintenance phase with a target daily dose of 300 mg of protein per allergen.
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Comparador activo: Standard of Care (Elimination Diet)
Participants will continue standard management consisting of strict elimination of peanut and tree nuts from the diet and use of rescue medications, including epinephrine, in case of accidental exposure.
Participants will be monitored according to the study schedule and will undergo follow-up assessments comparable to the experimental group.
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Standard management consisting of strict dietary avoidance of peanut and tree nuts, along with the use of rescue medications, including epinephrine, in the event of accidental allergen exposure.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Immunotherapy Efficacy
Periodo de tiempo: Up to 21 months after starting oral immunotherapy
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Evaluation of immunotherapy efficacy defined as achieving tolerance to a cumulative dose of 4444 mg of protein during OFC-2 for at least one allergen that elicited a reaction during OFC-1, compared with the control group.
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Up to 21 months after starting oral immunotherapy
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of Participants Tolerating at least 2, 3, 4 or 5 Allergens at a Cumulative Dose of 4444 mg During OFC-2
Periodo de tiempo: Up to 21 months after starting oral immunotherapy
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Proportion of participants who tolerate a cumulative dose of 4444 mg of protein for at least 2, 3, 4, or 5 allergens during OFC-2 (post-treatment oral food challenge).
Tolerance is defined as consumption of the full cumulative dose without dose-limiting allergic symptoms.
The outcome will be summarized as the proportion of participants meeting each threshold and compared between study groups.
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Up to 21 months after starting oral immunotherapy
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Change in Maximum Tolerated Allergen Dose from OFC-1 to OFC-2
Periodo de tiempo: Up to 21 months after starting oral immunotherapy
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Change in the maximum tolerated dose (mg of protein) of allergens during oral food challenge from OFC-1 (baseline) to OFC-2 (post-treatment).
The maximum tolerated dose is defined as the highest cumulative dose ingested without dose-limiting allergic symptoms.
Changes will be analyzed within and between study groups.
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Up to 21 months after starting oral immunotherapy
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Incidence, Type and Severity of Adverse Events During Immunotherapy Compared with Control (WAO Grading)
Periodo de tiempo: Up to 21 months after starting oral immunotherapy
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Number, type, and severity of adverse events during immunotherapy compared with the control group, assessed based on symptom diaries and classified by severity according to the WAO scale.
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Up to 21 months after starting oral immunotherapy
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Change in Skin Prick Test (SPT) Wheal Diameter for Peanut and Tree Nut Allergens from Baseline to Final Assessment
Periodo de tiempo: Up to 21 months after starting oral immunotherapy
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Measurement of change in wheal diameter (mm) for peanut and tree nut allergens as assessed by skin prick testing (SPT) between baseline (OFC-1) and final assessment (OFC-2).
Wheal size will be recorded as the mean diameter and compared within and between study groups.
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Up to 21 months after starting oral immunotherapy
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Change from Baseline in Allergen-Specific IgE (sIgE) and IgG4 Levels
Periodo de tiempo: Up to 21 months after starting oral immunotherapy
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Change in serum concentrations of sIgE and IgG4 from baseline to post-treatment assessment.
Measurements will be performed using standardized immunoassays and analyzed as continuous variables to evaluate immunologic response to therapy.
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Up to 21 months after starting oral immunotherapy
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Change in Food Allergy-Related Quality of Life (FAQLQ)
Periodo de tiempo: Up to 21 months after starting oral immunotherapy
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Change in quality of life of patients and their families from baseline to post-treatment assessment, as measured using the Food Allergy Quality of Life Questionnaire (FAQLQ).
Scores will be analysed as continuous variables to assess the impact of treatment on daily functioning and well-being.
Scores range from 1 to 7, with higher scores indicating worse quality of life.
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Up to 21 months after starting oral immunotherapy
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Brough HA, Caubet JC, Mazon A, Haddad D, Bergmann MM, Wassenberg J, Panetta V, Gourgey R, Radulovic S, Nieto M, Santos AF, Nieto A, Lack G, Eigenmann PA. Defining challenge-proven coexistent nut and sesame seed allergy: A prospective multicenter European study. J Allergy Clin Immunol. 2020 Apr;145(4):1231-1239. doi: 10.1016/j.jaci.2019.09.036. Epub 2019 Dec 20.
- Andorf S, Manohar M, Dominguez T, Block W, Tupa D, Kshirsagar RA, Sampath V, Chinthrajah RS, Nadeau KC. Feasibility of sustained response through long-term dosing in food allergy immunotherapy. Allergy Asthma Clin Immunol. 2017 Dec 21;13:52. doi: 10.1186/s13223-017-0224-7. eCollection 2017.
- Chojnowska-Wojtowicz M, Lyzwa K, Zielinska J, Zagorska W, Grzela K. Prevalence of nut allergen sensitization among children in central Poland. Postepy Dermatol Alergol. 2023 Feb;40(1):40-46. doi: 10.5114/ada.2022.124730. Epub 2023 Feb 27.
- Lodge CJ, Waidyatillake N, Peters RL, Netting M, Dai X, Burgess J, Hornung CJ, Perrett KP, Tang MLK, Koplin JJ, Dharmage SC. Efficacy and safety of oral immunotherapy for peanut, cow's milk, and hen's egg allergy: A systematic review of randomized controlled trials. Clin Transl Allergy. 2023 Jul;13(7):e12268. doi: 10.1002/clt2.12268.
- Pasioti M, Xepapadaki P, Mathioudakis AG, Lakoumentas J, Efstathiou E, Papadopoulos NG. Current options in the management of tree nut allergy: A systematic review and narrative synthesis. Pediatr Allergy Immunol. 2024 May;35(5):e14132. doi: 10.1111/pai.14132.
- Upton JEM, Toscano-Rivero D, Ke D, Berenjy A, Lejtenyi D, Beaudette L, Yin X, Li CH, Duan LY, Cohen CG, Kim V, Marzouk S, Grunebaum E, McCusker CT, Mazer B, Eiwegger T, Ben-Shoshan M. Peanut Oral Immunotherapy Using 30 and 300 mg Maintenance Doses. J Allergy Clin Immunol Pract. 2026 Jan;14(1):223-232.e7. doi: 10.1016/j.jaip.2025.10.007. Epub 2025 Oct 16.
- Upton JEM, Li CH, Berenjy A, Galper A, Yin X, Celik A, Duan L, Wong S, Ditlof CM, San Diego KE, Hoang JA, Ben-Shoshan M, Kothari A, Hung L, Monteiro M, Phue WH, Moraes TJ, Eiwegger T. Safety and Efficacy of Very Low-Dose Multi-Nut Oral Immunotherapy in Children. Clin Transl Allergy. 2025 Dec;15(12):e70125. doi: 10.1002/clt2.70125.
- Turner PJ, Ansotegui IJ, Campbell DE, Cardona V, Carr S, Custovic A, Durham S, Ebisawa M, Geller M, Gonzalez-Estrada A, Greenberger PA, Hossny E, Irani C, Leung ASY, Levin ME, Muraro A, Oppenheimer JJ, Ortega Martell JA, Pouessel G, Rial MJ, Senna G, Tanno LK, Wallace DV, Worm M, Morais-Almeida M; WAO Anaphylaxis Committee and WAO Allergen Immunotherapy Committee. Updated grading system for systemic allergic reactions: Joint Statement of the World Allergy Organization Anaphylaxis Committee and Allergen Immunotherapy Committee. World Allergy Organ J. 2024 Feb 10;17(3):100876. doi: 10.1016/j.waojou.2024.100876. eCollection 2024 Mar.
- Sampson HA, Arasi S, Bahnson HT, Ballmer-Weber B, Beyer K, Bindslev-Jensen C, Bird JA, Blumchen K, Davis C, Ebisawa M, Nowak-Wegrzyn A, Patel N, Peters RL, Sicherer S, Spergel J, Turner PJ, Yanagida N, Eigenmann PA. AAAAI-EAACI PRACTALL: Standardizing oral food challenges-2024 Update. Pediatr Allergy Immunol. 2024 Nov;35(11):e14276. doi: 10.1111/pai.14276.
- Jones SM, Kim EH, Nadeau KC, Nowak-Wegrzyn A, Wood RA, Sampson HA, Scurlock AM, Chinthrajah S, Wang J, Pesek RD, Sindher SB, Kulis M, Johnson J, Spain K, Babineau DC, Chin H, Laurienzo-Panza J, Yan R, Larson D, Qin T, Whitehouse D, Sever ML, Sanda S, Plaut M, Wheatley LM, Burks AW; Immune Tolerance Network. Efficacy and safety of oral immunotherapy in children aged 1-3 years with peanut allergy (the Immune Tolerance Network IMPACT trial): a randomised placebo-controlled study. Lancet. 2022 Jan 22;399(10322):359-371. doi: 10.1016/S0140-6736(21)02390-4.
- Erdle SC, Cook VE, Cameron SB, Yeung J, Kapur S, McHenry M, Chan ES, Mak R, Rex GA, Wong T, Soller L. Real-World Safety Analysis of Preschool Tree Nut Oral Immunotherapy. J Allergy Clin Immunol Pract. 2023 Apr;11(4):1177-1183. doi: 10.1016/j.jaip.2023.01.031. Epub 2023 Feb 1.
- Huang J, Puglisi LH, Cook KA, Kelso JM, Wangberg H. Safety and Feasibility of Peanut, Tree Nut, and Sesame Oral Immunotherapy in Infants and Toddlers in a Real-World Setting. J Allergy Clin Immunol Pract. 2025 Jan;13(1):185-191.e3. doi: 10.1016/j.jaip.2024.09.025. Epub 2024 Sep 30.
- Begin P, Winterroth LC, Dominguez T, Wilson SP, Bacal L, Mehrotra A, Kausch B, Trela A, Hoyte E, O'Riordan G, Seki S, Blakemore A, Woch M, Hamilton RG, Nadeau KC. Safety and feasibility of oral immunotherapy to multiple allergens for food allergy. Allergy Asthma Clin Immunol. 2014 Jan 15;10(1):1. doi: 10.1186/1710-1492-10-1.
- Nguyen K, Lewis MO, Hanna E, Alfaro MKC, Corrigan K, Buonanno J, Datta R, Brown-Whitehorn T, Spergel JM, Cianferoni A. Safety of Multifood Oral Immunotherapy in Children Aged 1 to 18 Years at an Academic Pediatric Clinic. J Allergy Clin Immunol Pract. 2023 Jun;11(6):1907-1913.e1. doi: 10.1016/j.jaip.2023.03.002. Epub 2023 Mar 10.
- Santos AF, Riggioni C, Agache I, Akdis CA, Akdis M, Alvarez-Perea A, Alvaro-Lozano M, Ballmer-Weber B, Barni S, Beyer K, Bindslev-Jensen C, Brough HA, Buyuktiryaki B, Chu D, Del Giacco S, Dunn-Galvin A, Eberlein B, Ebisawa M, Eigenmann P, Eiwegger T, Feeney M, Fernandez-Rivas M, Fiocchi A, Fisher HR, Fleischer DM, Giovannini M, Gray C, Hoffmann-Sommergruber K, Halken S, O'B Hourihane J, Jones CJ, Jutel M, Knol EF, Konstantinou GN, Lack G, Lau S, Mejias AM, Marchisotto MJ, Meyer R, Mortz CG, Moya B, Muraro A, Nilsson C, de Oliveira LCL, O'Mahony L, Papadopoulos NG, Perrett KP, Peters R, Podesta M, Poulsen LK, Roberts G, Sampson H, Schwarze J, Smith P, Tham E, Untersmayr E, Van Ree R, Venter C, Vickery B, Vlieg-Boerstra B, Werfel T, Worm M, Du Toit G, Skypala I. EAACI guidelines on the management of IgE-mediated food allergy. Allergy. 2025 Jan;80(1):14-36. doi: 10.1111/all.16345. Epub 2024 Oct 30.
- Lyons SA, Clausen M, Knulst AC, Ballmer-Weber BK, Fernandez-Rivas M, Barreales L, Bieli C, Dubakiene R, Fernandez-Perez C, Jedrzejczak-Czechowicz M, Kowalski ML, Kralimarkova T, Kummeling I, Mustakov TB, Papadopoulos NG, Popov TA, Xepapadaki P, Welsing PMJ, Potts J, Mills ENC, van Ree R, Burney PGJ, Le TM. Prevalence of Food Sensitization and Food Allergy in Children Across Europe. J Allergy Clin Immunol Pract. 2020 Sep;8(8):2736-2746.e9. doi: 10.1016/j.jaip.2020.04.020. Epub 2020 Apr 21.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
1 de septiembre de 2026
Finalización primaria (Estimado)
Finalización primaria
1 de septiembre de 2031
Finalización del estudio (Estimado)
Finalización del estudio
1 de diciembre de 2031
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
27 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
11 de agosto de 2026
Publicado por primera vez (Actual)
Publicado por primera vez
13 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
13 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
11 de agosto de 2026
Última verificación
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Hipersensibilidad a las nueces y los cacahuetes
- Enfermedades del sistema inmunológico
- Hipersensibilidad, Inmediata
- Hipersensibilidad
- Hipersensibilidad alimentaria
- Hipersensibilidad al maní
- Hipersensibilidad a las nueces
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Calidad de la atención médica
- Dieta, alimentos y nutrición
- Fenómeno fisiológico
- Indicadores de calidad, atención médica
- Fenómenos fisiológicos nutricionales
- Dieta
- Estándar de cuidado
- Elimination Diets
Otros números de identificación del estudio
Otros números de identificación del estudio
- Multifood
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified individual participant data (IPD) that underlie the results reported in this study will be made available to qualified researchers upon reasonable request. Data requests may be submitted beginning 9 months after publication of the primary study results. Approved data will be accessible for a period of up to 24 months, with potential extensions considered on a case-by-case basis.
Access will be granted to researchers conducting independent scientific research, following review and approval of a detailed research proposal and a corresponding Statistical Analysis Plan (SAP). A Data Sharing Agreement (DSA) must be executed prior to data release.
For additional information or to submit a data access request, please contact: katarzyna.grzela@wum.edu.pl.
Marco de tiempo para compartir IPD
Data requests may be submitted beginning 9 months after publication of the primary study results.
Approved data will be made available for a period of up to 24 months.
Requests for extension beyond this period will be considered on a case-by-case basis.
Criterios de acceso compartido de IPD
Access to de-identified individual participant data (IPD) may be requested by qualified researchers conducting independent scientific research.
Access will be granted following review and approval of a research proposal and a corresponding Statistical Analysis Plan (SAP), and upon execution of a Data Sharing Agreement (DSA).
For additional information or to submit a request, please contact katarzyna.grzela@wum.edu.pl
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .