Un estudio que evalúa la eficacia, seguridad, farmacocinética y farmacodinámica de crovalimab en participantes pediátricos con síndrome urémico hemolítico atípico (aHUS) (COMMUTE-p)
17 de agosto de 2026 actualizado por: Hoffmann-La Roche
Un estudio de fase III, multicéntrico, de un solo brazo que evalúa la eficacia, seguridad, farmacocinética y farmacodinamia de crovalimab en pacientes pediátricos con síndrome urémico hemolítico atípico (aHUS)
Este estudio tiene como objetivo evaluar la eficacia y seguridad de crovalimab en participantes pediátricos con SHUa.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
41
Fase
- Fase 3
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.
Ubicaciones de estudio
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São Paulo
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São Paulo, São Paulo, Brasil, 05403-900
- Inst. Da Criança- Faculdade de Medicina Usp
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Ghent, Bélgica, 9000
- UZ Gent
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Leuven, Bélgica, 3000
- UZ Leuven Gasthuisberg
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Quebec
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Montreal, Quebec, Canadá, H3T 1C5
- CHU Sainte-Justine
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Children's Hospital Colorado
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68198
- University of Nebraska
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Hackensack University Medical Center
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Montpellier, Francia, 34295
- Hopital Arnaud de Villeneuve
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Paris, Francia, 75743
- Gh Necker Enfants Malades
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Gujarat
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Ahmedabad, Gujarat, India, 380016
- Institute of Kidney Diseases and Research Centre
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Haryana
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Gurgaon, Haryana, India, 122001
- Medanta-The Medicity
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, India, 110029
- All India Institute of Medical Sciences (AIIMS)
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Aichi, Japón, 474-8710
- Aichi Children?s Health and Medical Center
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Chibashi, Chibaken, Japón, 266-0007
- Chiba Children's Hospital
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Zapopan, México, 45116
- Hospital de Especialidades Puerta de Hierro S.A de C.V.
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Gdansk, Polonia, 80-294
- Uniwersyteckie Centrum Kliniczne
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Lodz, Polonia, 93-338
- Instytut ?Centrum Zdrowia Matki Polki
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Beijing, Porcelana, 100034
- Peking University First Hospital
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Beijing, Porcelana, 100045
- Beijing Children's Hospital, Capital Medical University
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Hangzhou, Porcelana, 310051
- The children's hospital , Zhejiang university school of medicine
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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
Edades elegibles para estudiar
4 semanas a 17 años (Niño)
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
- Peso corporal >= 5 kg en la selección.
- Vacunación contra Neisseria meningitis serotipos A, C, W e Y; vacunación contra el serotipo B, de acuerdo con las recomendaciones nacionales de vacunación.
- Vacunación frente a Haemophilus influenzae tipo B y Streptococcus pneumoniae, según recomendaciones nacionales de vacunación.
- Para pacientes que continúan recibiendo otras terapias concomitantemente con crovalimab (p. ej., inmunosupresores, corticosteroides, mTORi o inhibidores de la calcineurina): dosis estable durante >= 28 días antes de la selección y hasta la primera administración de crovalimab.
- Para mujeres participantes en edad fértil: un acuerdo para permanecer en abstinencia o usar métodos anticonceptivos.
- Los participantes con un trasplante de riñón anterior son elegibles si tienen antecedentes conocidos de SHUa mediado por complemento antes del trasplante de riñón.
- Inicio de la presentación inicial de MAT dentro de los 28 días anteriores a la primera dosis de crovalimab (solo para la cohorte Naive).
- Tratamiento documentado con eculizumab o ravulizumab (solo para Switch Cohort).
- Evidencia clínica de respuesta a un inhibidor de C5 (solo para Switch Cohort).
- MAT mal controlada después del tratamiento con otro inhibidor de C5 (solo para participantes de C5 SNP en la cohorte pretratada).
- Polimorfismo C5 conocido (solo para participantes de C5 SNP en la cohorte pretratada).
Criterio de exclusión:
- MAT asociada a enfermedad renal no relacionada con SHUa.
- Test de Coombs directo positivo.
- Diálisis crónica y/o enfermedad renal terminal.
- MAT relacionada con la exposición al fármaco identificada.
- Presencia o antecedentes de una afección que podría desencadenar MAT, como una neoplasia maligna, un trasplante de médula ósea o de órganos (que no sea un trasplante de riñón) o una enfermedad autoinmune.
- Antecedentes de una enfermedad renal, distinta del SHUa.
- Antecedentes de infección por Neisseria meningitidis dentro de los 6 meses posteriores a la inscripción en el estudio.
- Inmunodeficiencia conocida o sospechada (p. ej., antecedentes de infecciones recurrentes frecuentes).
- Prueba de VIH positiva.
- Infección bacteriana, viral o fúngica sistémica activa dentro de los 14 días anteriores a la primera administración de crovalimab.
- Presencia de fiebre (>= 38oC) dentro de los 7 días previos a la primera administración de crovalimab.
- Disfunción o falla de órganos multisistémicos.
- Tratamiento reciente de IgIV.
- Embarazada o amamantando o con la intención de quedar embarazada.
- Participación en otro estudio de tratamiento de intervención con un agente en investigación o uso de cualquier terapia experimental dentro de los 28 días posteriores a la selección o dentro de las cinco vidas medias de ese producto en investigación, lo que sea mayor.
- Uso reciente de ácido tranexámico.
- Tratamiento actual o previo con un inhibidor del complemento (solo para la cohorte ingenua).
- El primer inicio de intercambio de plasma/infusiones de plasma (PE/PI) no debe ser más de 28 días antes de la primera administración de crovalimab (solo para la cohorte Naive).
- PE/PI no debe administrarse dentro de las 6 horas posteriores a la primera administración de crovalimab (solo para la cohorte Naive).
- Recibir PE/PI dentro de las 8 semanas posteriores a la primera administración de crovalimab (solo cambio de cohorte).
- Positivo para infecciones activas de hepatitis B y/o C (VHB/VHC) (para participantes de la cohorte de cambio y de la cohorte pretratada con SNP C5 que cambiaron y que recientemente recibieron tratamiento con un inhibidor de C5).
- Crioglobulinemia en la selección (para participantes de la cohorte Switch y la cohorte C5 SNP que recibieron recientemente tratamiento con un inhibidor de C5).
- Condición documentada que lleva a MAT no SHUa: púrpura trombocitopénica trombótica (PTT), Escherichia Coli productora de toxina Shiga (STEC)-TMA, SHU neumocócico, MAT secundaria a defecto de cobalamina C y MAT relacionada con nefropatía por diacilglicerol quinasa ε (DGKE).
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Crovalimab
Los participantes se inscribirán en tres cohortes: [1] Cohorte ingenua: participantes que no han sido tratados previamente con terapia de inhibidores del complemento; [2] Cohorte de cambio: participantes que cambiaron a crovalimab desde otro inhibidor de C5 y [3] Cohorte pretratada (incluye participantes de C5 SNP (polimorfismo de nucleótido único)): participantes que recibieron tratamiento con otro inhibidor de C5 y posteriormente lo suspendieron.
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Crovalimab se administrará en una dosis de 1000 mg por vía intravenosa (IV) (para participantes que pesen => 40 a = 100 kg) el día 1 de la semana 1.
En la semana 1, día 2 y en las semanas 2, 3 y 4, se administrará crovalimab a una dosis de 340 mg por vía subcutánea (SC).
En la semana 5 y cada cuatro semanas a partir de entonces, se administrará en una dosis de 680 mg SC (para participantes que pesen => 40 a = 100 kg).
Inscripción de participantes con un peso de =20 kg a =5 kg a
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Naïve Cohort: Percentage of Participants With Complete Thrombotic Microangiopathy Response (cTMAr) Anytime From Baseline to Week 25 (After 24 Weeks on Treatment)
Periodo de tiempo: From baseline up to Week 25
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cTMAr was defined by meeting all of the following criteria at two separate assessments, obtained at least 4 weeks (a minimum of 26 days) apart, and any measurement in between: Platelet count ≥ lower limit of normal (LLN); Lactate dehydrogenase (LDH) ≤ upper limit of normal (ULN); and ≥ 25% decrease in serum creatinine from baseline.
Participants with normalized creatinine (i.e., LLN ≤ creatinine ≤ ULN) at baseline were excluded from analysis.
95% confidence interval (CI) was calculated using Wilson's score method.
Percentage has been rounded off.
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From baseline up to Week 25
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Naïve and Switch Cohorts: Percentage of Participants Requiring Dialysis at Baseline or Week 25 and Who Completed 24 Weeks of Treatment
Periodo de tiempo: Baseline and Week 25
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Participants were considered to be on dialysis at baseline or at Week 25 if dialysis occurred within 5 days prior to the first crovalimab administration or prior to the end date of the primary treatment period, respectively.
The percentage of participants who required dialysis at baseline and Week 25 has been reported here.
Percentages have been rounded off.
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Baseline and Week 25
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Naïve and Switch Cohorts: Percentage of Participants With Change From Baseline to Week 25 (After 24 Weeks on Treatment) on Dialysis Status (Yes/No)
Periodo de tiempo: From baseline up to Week 25
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Participants were considered as being on dialysis at baseline or at Week 25 if dialysis occurred within 5 days prior to the first crovalimab administration or prior to the end date of the primary treatment period, respectively.
Percentages have been rounded off.
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From baseline up to Week 25
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Naïve and Switch Cohorts: Observed Value of Estimated Glomerular Filtration Rate (eGFR), as Calculated From Central Serum Creatinine
Periodo de tiempo: Baseline, Weeks 2, 3, 4, 5, 7, 9, 11, 13, 17, 21, and 25
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GFR is an index of kidney function that describes the flow rate of filtered fluid through the kidneys.
It was categorized according to chronic kidney disease (CKD) staging criteria.
eGFR was calculated using the creatinine-based bedside Schwartz equation.
eGFR (milliliters per minute per 1.73 square meter [mL/min/1.73
m^2])=0.413*(height
[ht]/serum creatinine [sCr]), if height is expressed in centimeters, or 41.3*(ht/sCr), if height is expressed in meters.
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Baseline, Weeks 2, 3, 4, 5, 7, 9, 11, 13, 17, 21, and 25
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Naïve and Switch Cohorts: Change From Baseline to Week 25 in eGFR, as Calculated From Central Serum Creatinine
Periodo de tiempo: Baseline, Weeks 2, 3, 4, 5, 7, 9, 11, 13, 17, 21, and 25
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GFR is an index of kidney function that describes the flow rate of filtered fluid through the kidneys.
It was categorized according to CKD staging criteria.
eGFR was calculated using the creatinine-based bedside Schwartz equation.
eGFR (mL/min/1.73
m^2])=0.413*(ht/sCr),
if height is expressed in centimeters, or 41.3*(ht/sCr), if height is expressed in meters.
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Baseline, Weeks 2, 3, 4, 5, 7, 9, 11, 13, 17, 21, and 25
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Naïve and Switch Cohorts: Percentage of Participants With Change From Baseline to Week 25 (After 24 Weeks on Treatment) in CKD Stage, as Assessed Based on eGFR Calculated From Central Serum Creatinine
Periodo de tiempo: From baseline up to Week 25
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CKD stage was assessed using eGFR, calculated from central serum creatinine using Creatinine-based bedside Schwartz equation & classified according to National Kidney Foundation CKD staging criteria as follows: G1 (≥90 mL/min/1.73
m²; normal or high kidney function), G2 (60-89 mL/min/1.73
m²; mildly decreased kidney function), G3a (45-59 mL/min/1.73
m²; mildly to moderately decreased kidney function), G3b (30-44 mL/min/1.73
m²; moderately to severely decreased kidney function), G4 (15-29 mL/min/1.73
m²; severely decreased kidney function), & G5 (<15 mL/min/1.73
m²; kidney failure).
Change in CKD stage from baseline to Week 25 was categorized as improved (participants who improved in CKD stage from Baseline to Week 25 were based on the number of participants who completed 24 weeks and were not Stage 1 at baseline), stable (no change), or worsened (participants with CKD Stage 1 to 4 at baseline) among participants who completed 24 weeks of treatment.
Percentages have been rounded off.
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From baseline up to Week 25
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Naïve and Switch Cohorts: Observed Value of Platelet Count
Periodo de tiempo: Baseline and Week 25
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Baseline and Week 25
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Naïve and Switch Cohorts: Observed Value of LDH
Periodo de tiempo: Baseline and Week 25
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Baseline and Week 25
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Naïve and Switch Cohorts: Observed Value of Hemoglobin (Hb)
Periodo de tiempo: Baseline and Week 25
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Baseline and Week 25
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Naïve and Switch Cohorts: Change From Baseline to Week 25 (After 24 Weeks on Treatment) in Platelet Count
Periodo de tiempo: Baseline and Week 25
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Baseline and Week 25
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Naïve and Switch Cohorts: Change From Baseline to Week 25 (After 24 Weeks on Treatment) in LDH
Periodo de tiempo: Baseline and Week 25
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Baseline and Week 25
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Naïve and Switch Cohorts: Change From Baseline to Week 25 (After 24 Weeks on Treatment) in Hb
Periodo de tiempo: Baseline and Week 25
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Baseline and Week 25
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Naïve Cohort: Percentage of Participants With Platelet Count ≥ LLN at Two Separate Assessments, Obtained at Least 4 Weeks Apart (Minimum of 26 Days), by Week 25 (After 24 Weeks on Treatment)
Periodo de tiempo: From baseline up to Week 25
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This event was confirmed at two separate assessments obtained at least 4 weeks (a minimum of 26 days) apart and any measurement in between.
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From baseline up to Week 25
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Naïve Cohort: Percentage of Participants With LDH Normalization (i.e., ≤ ULN) at Two Separate Assessments, Obtained at Least 4 Weeks Apart (Minimum of 26 Days), by Week 25 (After 24 Weeks on Treatment)
Periodo de tiempo: From baseline up to Week 25
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Percentage has been rounded off.
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From baseline up to Week 25
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Naïve Cohort: Percentage of Participants With ≥ 25% Decrease in Serum Creatinine From Baseline, Confirmed at Two Separate Assessments, Obtained at Least 4 Weeks Apart (Minimum of 26 Days), by Week 25 (After 24 Weeks on Treatment)
Periodo de tiempo: From baseline up to Week 25
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Percentage has been rounded off.
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From baseline up to Week 25
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Naïve Cohort: Time to cTMAr
Periodo de tiempo: From baseline up to Week 25
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cTMAr was defined by meeting all of the following criteria at two separate assessments, obtained at least 4 weeks (a minimum of 26 days) apart, and any measurement in between: Platelet count ≥ LLN; LDH ≤ ULN; and ≥ 25% decrease in serum creatinine from baseline.
Kalpan-Meier (K-M) method was used to estimate median time to cTMAr.
Data for participants who did not reach cTMAr during PTP were censored at the date of their last visit when cTMAr was assessed during the primary treatment period or prior to the treatment discontinuation, whichever was earlier.
Data for participants who received a prohibited therapy during the PTP were censored at the date of the first received prohibited therapy during the primary treatment period or prior to the treatment discontinuation, whichever was earlier.
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From baseline up to Week 25
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Naïve Cohort: Duration of cTMAr, Among Participants Who Achieved cTMAr
Periodo de tiempo: From baseline up to primary CCOD (up to 190 weeks)
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cTMAr=meeting following criteria at 2 separate assessments, obtained at least 4 weeks (minimum of 26 days) apart & any measurement in between: Platelet count ≥LLN; LDH ≤ULN; & ≥25% decrease in serum creatinine from baseline.
Duration of cTMAr was calculated as time from start of cTMAr to end of cTMAr.
End of cTMAr=when all of following criteria were met during same visit & confirmed at assessment that took place at least 4 weeks (minimum of 26 days) later: Platelet count <LLN; LDH >ULN; & ≥25% increase in serum creatinine from baseline & ULN.
K-M method was used to estimate the median duration of cTMAr.
Data for participants with no observed end of cTMAr at CCOD were censored at the date of their last visit when cTMAr was assessed before CCOD or before treatment discontinuation, whichever was earlier.
Data for participants who received prohibited therapy before CCOD were censored at date of first receiving prohibited therapy or before treatment discontinuation, whichever was earlier.
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From baseline up to primary CCOD (up to 190 weeks)
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Naïve Cohort: Percentage of Participants With cTMAr Ongoing at Week 25
Periodo de tiempo: At Week 25
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cTMAr at Week 25 was defined by meeting all of the three cTMAr criteria at Week 25: Platelet count ≥ LLN; LDH ≤ ULN; and ≥ 25% decrease in serum creatinine from baseline.
Percentage has been rounded off.
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At Week 25
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Switch Cohort: Percentage of Participants With Maintained Thrombotic Microangiopathy Response Control (mTMAc) From Baseline Through Week 25 (After 24 Weeks on Treatment)
Periodo de tiempo: From baseline up to Week 25
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mTMAc was considered not maintained if all of the following criteria were met during one of the visits between baseline and Week 25, and were confirmed at an assessment that took place at least 4 weeks (a minimum of 26 days) later: Platelet count < LLN; LDH > ULN; and 25% increase in serum creatinine from baseline.
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From baseline up to Week 25
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All Cohorts: Number of Participants With Adverse Events (AEs)
Periodo de tiempo: Up to approximately 8 years
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An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Up to approximately 8 years
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All Cohorts: Number of Participants With Injection-site Reactions, Infusion-related Reactions, Hypersensitivity, Malignant Hypertension (Including Malignant Renal Hypertension), and Infections (Including Meningococcal Meningitis)
Periodo de tiempo: Up to approximately 8 years
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An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Up to approximately 8 years
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All Cohorts: Number of Participants With AEs Leading to Study Drug Discontinuation
Periodo de tiempo: Up to approximately 8 years
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An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Up to approximately 8 years
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Switch Cohort: Number of Participants With Clinical Manifestations of Drug-target-drug Complexes (DTDCs)
Periodo de tiempo: Up to approximately 8 years
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Crovalimab and eculizumab bind distinct epitopes on complement component C5, and formation of DTDCs comprising crovalimab, eculizumab, and C5 are formed when participants switch treatment.
DTDCs will be characterized using size exclusion chromatography (SEC) coupled with enzyme-linked immunosorbent assay (ELISA).
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Up to approximately 8 years
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All Cohorts: Serum Concentrations of Crovalimab Over Time
Periodo de tiempo: Up to approximately 8 years
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Up to approximately 8 years
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All Cohorts: Number of Participants With Anti-drug Antibodies (ADAs) to Crovalimab
Periodo de tiempo: Up to approximately 8 years
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Participants will be considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following stuy drug exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples is at least 4-fold greater than the titer of the baseline sample (treatment-enhanced ADA response).
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Up to approximately 8 years
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All Cohorts: Observed Value of Total Complement Activity 50 (CH50), as Measured by Liposome Immunoassay (LIA)
Periodo de tiempo: Up to approximately 8 years
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Up to approximately 8 years
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All Cohorts: Change From Baseline in CH50 Over Time, as Measured by LIA
Periodo de tiempo: Up to approximately 8 years
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Up to approximately 8 years
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All Cohorts: Observed Value of Free Complement Component 5 (C5) Concentrations in Crovalimab-treated Participants
Periodo de tiempo: Up to approximately 8 years
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Up to approximately 8 years
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All Cohorts: Change From Baseline in Free C5 Concentrations Over Time in Crovalimab-treated Participants
Periodo de tiempo: Up to approximately 8 years
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Up to approximately 8 years
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All Cohorts: Observed Value of Total C5 Concentrations in Crovalimab-treated Participants
Periodo de tiempo: Up to approximately 8 years
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Up to approximately 8 years
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All Cohorts: Change From Baseline in Total C5 Concentrations Over Time in Crovalimab-treated Participants
Periodo de tiempo: Up to approximately 8 years
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Up to approximately 8 years
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Clinical Trials, Hoffmann-La Roche
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 (Actual)
17 de noviembre de 2021
Finalización primaria (Actual)
4 de julio de 2025
Finalización del estudio (Estimado)
19 de mayo de 2029
Fechas de registro del estudio
Enviado por primera vez
6 de julio de 2021
Primero enviado que cumplió con los criterios de control de calidad
6 de julio de 2021
Publicado por primera vez (Actual)
12 de julio de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Citopenia
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades hematológicas
- Anemia Hemolítica
- Anemia
- Trastornos de las plaquetas sanguíneas
- Microangiopatías trombóticas
- Trombocitopenia
- Uremia
- Enfermedades hemic y linfáticas
- Síndrome urémico hemolítico
- Síndrome Urémico Hemolítico Atípico
Otros números de identificación del estudio
- BO42354
- 2023 (Subvención/contrato del NIH de EE. UU.: GRAMMY Museum Foundation)
- 2020-002437-15 (Número EudraCT)
- 2023-505638-82-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Los investigadores calificados pueden solicitar acceso a datos de pacientes individuales a través de la plataforma de solicitud de datos de estudios clínicos (www.vivli.org).
Más detalles sobre los criterios de Roche para estudios elegibles están disponibles aquí (https://vivli.org/ourmember/roche/).
Para obtener más detalles sobre la Política global de Roche sobre el intercambio de información clínica y cómo solicitar acceso a documentos de estudios clínicos relacionados, consulte aquí (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
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. .