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Segurança, tolerabilidade, farmacocinética, farmacodinâmica e eficácia de SAR442501 em participantes pediátricos com acondroplasia (upreACH-2)

1 de junho de 2026 atualizado por: Sanofi

Um estudo de fase 2, aberto, multicêntrico, de coorte sequencial de 2 estágios, de escalonamento de dose para avaliar a segurança, tolerabilidade, farmacocinética, farmacodinâmica e eficácia do SAR442501 subcutâneo em participantes pediátricos com acondroplasia

Este é um estudo de Fase 2, aberto e multicêntrico para avaliar a segurança, tolerabilidade e eficácia do SAR442501 em crianças desde o nascimento até os 12 anos de idade com Acondroplasia.

Visão geral do estudo

Status

Rescindido

Condições

Intervenção / Tratamento

Descrição detalhada

Até aproximadamente 275 semanas: 3 semanas de triagem + 52 semanas de período de tratamento primário + até aproximadamente 216 semanas de período de tratamento estendido + 4 semanas de acompanhamento.

Tipo de estudo

Intervencional

Inscrição (Real)

16

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Austrália
    • Victoria
      • Parkville, Victoria, Austrália, 3052
        • Investigational Site Number : 0360001
  • China
      • Shanghai, China, 200120
        • Investigational Site Number : 1560002
      • Wuhan, China, 430030
        • Investigational Site Number : 1560001
  • Coréia do Sul
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, Coréia do Sul, 03080
        • Investigational Site Number : 4100001
      • Seoul, Seoul-teukbyeolsi, Coréia do Sul, 06351
        • Investigational Site Number : 4100002
  • Espanha
    • Basque Country
      • Vitoria-Gasteiz, Basque Country, Espanha, 01008
        • Investigational Site Number : 7240002
    • Catalunya [Cataluña]
      • Esplugues de Llobregat, Catalunya [Cataluña], Espanha, 08950
        • Investigational Site Number : 7240001
  • Itália
    • Lombardy
      • Milan, Lombardy, Itália, 20122
        • Investigational Site Number : 3800002
    • Roma
      • Rome, Roma, Itália, 00168
        • Investigational Site Number : 3800001

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • Os participantes devem ter ACH com mutação confirmada no gene FGFR3
  • Os participantes e/ou pais ou representantes legais devem estar dispostos e ser capazes de realizar todos os procedimentos do estudo com o melhor de sua capacidade física.
  • Pai(s) ou representante(s) legal(is) capaz(s) de dar consentimento informado assinado e participantes capazes de dar consentimento quando aplicável.

Critério de exclusão:

  • Tem hipocondroplasia (ou mutação N540K) ou condição de baixa estatura diferente de ACH (por exemplo, trissomia 21, pseudocondroplasia)
  • Os participantes receberam qualquer dose de medicamentos ou produto experimental, incluindo hormônio de crescimento humano, destinado a afetar a estatura ou proporções corporais dos participantes dentro de 6 meses após a inscrição (Semana 0/Dia 1/Visita 2).
  • Ter histórico de fechamento da placa de crescimento.
  • Fratura de ossos longos dentro de 3 meses após a inscrição (Semana 0/Dia 1/Visita 2)
  • Evidência atual de distúrbio/ceratopatia da córnea ou da retina.
  • Os participantes tiveram uma intervenção cirúrgica anterior envolvendo o forame magno (apenas Estágio 2).
  • Hiperfosfatemia.

As informações acima não pretendem conter todas as considerações relevantes para uma potencial participação num ensaio clínico.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição sequencial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Coorte 1
Medicamento: SAR442501
Solução injetável; Injeção subcutânea
Experimental: Coorte 2
Medicamento: SAR442501
Solução injetável; Injeção subcutânea
Experimental: Coorte 3
Medicamento: SAR442501
Solução injetável; Injeção subcutânea

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Stage 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Prazo: From the first dose of study drug administration (Day 1) up to early termination of the study, approximately 58 weeks (Stage 1: SAR442501 Dose A) and 46 weeks (Stage 1: SAR442501 Dose B)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was defined as any untoward medical occurrence (whether considered to be related to study drug or not) that at any dose: resulted in death; or was life-threatening; or required inpatient hospitalization or prolongation of existing hospitalization; or resulted in persistent or significant disability/incapacity; or was a congenital anomaly/birth defect; or was an important medical event. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required. The TEAEs were defined as events that were newly reported or reported to worsen in severity after the start of study drug up to 5 days post last dose of the study drug.
From the first dose of study drug administration (Day 1) up to early termination of the study, approximately 58 weeks (Stage 1: SAR442501 Dose A) and 46 weeks (Stage 1: SAR442501 Dose B)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Stage 1: Change From Baseline to Weeks 26 and 52 in Growth Velocity Z-Score
Prazo: Baseline (Day 1) and Weeks 26 and 52
Post-treatment annualized growth velocity (AGV) was calculated from height measurements collected during the study. AGV was calculated as: AGV (centimeter per year)= (Height at Date 2 - Height at Date 1) divided by interval length in days x 365.25, where interval length in days was calculated as (Date 2 - Date 1+1). Z scores were calculated using LMS methods (Box Cox power L, Median M and Variation S), where appropriate: If L≠ 0: Z= [(AGV/M)^L-1]/(LxS); If L= 0: Z= ln(AGV/M)/S. A Z score of 0 represents the mean AGV of the reference achondroplasia (ACH) population. For AGV Z scores in children with ACH: Higher Z scores represent better outcomes, meaning faster linear growth relative to age and sex matched reference populations. Lower Z scores represent worse outcomes, indicating slower growth compared to reference norms. Baseline value was defined as last available pre dose height measurement meeting statistical analysis plan specified time interval definitions.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Annualized Growth Velocity
Prazo: Baseline (Day 1) and Weeks 26 and 52
The AGV was defined as follows: (Height at Date 2 - height at Date 1) divided by interval length in days x 365.25, where the interval length in days was calculated as (Date 2 - Date 1 +1) days. The post-treatment AGV was calculated from height measurements collected during the study. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Height Z-Score
Prazo: Baseline (Day 1) and Weeks 26 and 52
Post-treatment AGV was calculated from height measurements collected during the study. AGV was calculated as: AGV (centimeter per year)= (Height at Date 2 - Height at Date 1) divided by interval length in days x 365.25, where interval length in days was calculated as (Date 2 - Date 1+1). Z scores were calculated using LMS methods (Box Cox power L, Median M and Variation S), where appropriate: If L≠ 0: Z= [(AGV/M)^L-1]/(LxS); If L= 0: Z= ln(AGV/M)/S. A Z score of 0 represents the mean AGV of the reference population (ACH). For AGV Z scores in children with ACH: Higher Z scores represent better outcomes, meaning faster linear growth relative to age and sex matched reference populations. Lower Z scores represent worse outcomes, indicating slower growth compared to reference norms. Baseline value was defined as last available pre dose height measurement meeting statistical analysis plan specified time interval definitions.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Upper to Lower Body Segment Ratio
Prazo: Baseline (Day 1) and Weeks 26 and 52
The upper to lower body segment ratio was calculated by (standing height or total length - lower body segment length) divided by lower body segment length. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Upper to Lower Extremity Ratio
Prazo: Baseline (Day 1) and Weeks 26 and 52
The upper to lower extremity ratio was calculated by (upper arm + forearm length) divided by (upper leg + lower leg length). The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Sitting to Standing Height Ratio
Prazo: Baseline (Day 1) and Weeks 26 and 52
The sitting to standing height ratio was calculated by sitting height divided by standing height, or crown to rump length divided by total length. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Arm Span to Height Ratio
Prazo: Baseline (Day 1) and Weeks 26 and 52
The arm span to height ratio was calculated by arm span divided by standing height, or arm span divided by total length. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Upper Arm to Forearm Length Ratio
Prazo: Baseline (Day 1) and Weeks 26 and 52
The upper arm to forearm length ratio was calculated by upper arm length divided by forearm length. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Upper Leg to Lower Leg Ratio
Prazo: Baseline (Day 1) and Weeks 26 and 52
The upper leg to lower leg length ratio was calculated by upper leg length divided by lower leg length. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Head Circumference to Height Ratio
Prazo: Baseline (Day 1) and Weeks 26 and 52
The head circumference to height ratio was calculated by head circumference divided by standing height, or head circumference divided by total length. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 2: Change From Baseline to Week 52 in Brainstem, Skull, and Spine Morphometric and Volumetric Parameters
Prazo: Baseline (Day 1) and Week 52
The magnetic resonance imaging was planned to be collected to measure foramen magnum and other brainstem, skull, and spine morphometric parameters in Stage 2 participants. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Week 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Social Score, Emotional Score, and School Functioning Score
Prazo: Baseline (Day 1) and Weeks 26 and 52
The pediatric quality of life (PedsQL) Generic Core Scales assesses pediatric health related quality of life (HRQOL) across functioning domains. Items use a 5-point scale (0=Never to 4=Almost Always). Responses are reverse scored and linearly transformed to a 0-100 scale (0→100, 1→75, 2→50, 3→25, 4→0), where higher scores indicate better quality of life (fewer problems). Domain scores for Social, Emotional, and School Functioning are calculated from the transformed item scores. If more than 50% of items in a domain are missing, the domain score is not computed. If at least 50% are completed, the domain score equals the mean of the non missing transformed item scores. All domain scores range from 0 (almost always) to 100 (never), with higher scores indicate better HRQOL. Baseline was defined as the last available value prior to the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Psychosocial Health Summary Score, Physical Health Summary Score, and Total Score
Prazo: Baseline (Day 1) and Weeks 26 and 52
The PedsQL core scale was a brief, standardized, generic instrument that was used to measure HRQOL in various pediatric conditions. Psychosocial health summary scores were the meaning of item scores in emotional, social, and school functioning scales; and Physical health summary scores were the meaning of item scores in physical scale. Total score was the mean of all the item scores in all scales. Psychosocial and physical health summary scores and total scores each ranged from 0 (almost always) to 100 (never). Higher scores indicate better HRQOL. For participants aged 5 to 7, only parents completed the questionnaire. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Mobility Score
Prazo: Baseline (Day 1) and Weeks 26 and 52
The screening tool for everyday mobility and symptoms (STEMS) was completed by clinicians for participants 5 years of age and older. The STEMS captures mobility, use of mobility aides, and impact of pain and/or fatigue at the end of the day across 3 environments: home, school/work and community. Mobility aides were recorded using numeric 5-point rating scale, score ranged from 1 to 5, where 1= independent on all surfaces including stairs, 2= use of sticks, 3= use of crutches, 4= use of wheeled walking device, and 5= use of wheelchair or mobility scooter. Lower score indicated the better outcome. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Participants Reported Symptoms
Prazo: Baseline (Day 1) and Weeks 26 and 52
The STEMS was completed by clinicians for participants 5 years of age and older. The STEMS captures mobility, use of mobility aides, and impact of pain and/or fatigue at the end of the day across 3 environments: home, school/work and community. Participant reported symptoms were recorded using letters where A= no pain or fatigue, B1= pain only, B2= fatigue and C= pain and fatigue. This was completed for each of the 3 environments resulting in 3 scores, whereby the numeric rating reflects the use of mobility aides and the letter reflects the symptoms. The baseline value was defined as the last available value before the first dose of study drug. Only participants with a Baseline response of "A" were included in the "A to A," "A to B1," and "A to missing" categories at each time point. Similarly, only participants with a Baseline response of "B1" were included in the "B1 to A" and "B1 to missing" categories at each time point.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in General Fatigue, Sleep/Rest Fatigue and Cognitive Fatigue Scores and Total Score
Prazo: Baseline (Day 1) and Weeks 26 and 52
The PedsQL Multidimensional Fatigue Scale measures fatigue across 3 subscales:General Fatigue, Sleep/Rest Fatigue and Cognitive Fatigue. Items are rated on a 5 point scale (0=Never to 4=Almost Always). Responses are reverse scored and linearly transformed to a 0-100 scale (0→100, 1→75, 2→50, 3→25, 4→0), with higher scores indicate less fatigue and better functioning. Subscale scores are calculated as mean of transformed item scores within each subscale. A Total Score was calculated as mean of all transformed items across subscales. If more than 50% of items are missing within a subscale or across total scale, corresponding score is not computed. If at least 50% are completed, scores are calculated as mean of non missing transformed items. All scores range from 0 (no pain) to 100 (severe pain), with higher scores indicate less fatigue. Baseline was defined as last available value prior to first dose of study drug. For participants aged 5-7 years, only parent proxy report was completed.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Current Pain and Worst Pain Rating (PPQ) Score
Prazo: Baseline (Day 1) and Weeks 26 and 52
The PedsQL PPQ assesses current pain and worst pain intensity in the last week using a visual analog scale as well as pain location using a body map. Current and worst pain were scored separately, and scoring was based on the line length to the nearest 0.5 centimeter (5 millimeter). The score ranged from 0 (no pain) to 100 (severe pain), where higher scores indicated greater levels of pain intensity. The PedsQL PPQ was only administered in participants ages 5 years of age and older using both self-report (ages 8 and older) and parent proxy report (ages 5 and older) forms in all countries. For participants aged 5 to 7, only parents completed the questionnaire. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 2: Change From Baseline to Week 52 in Achievement of Gross Motor, Fine Motor, Communication, and Feeding Milestones
Prazo: Baseline (Day 1) and Week 52
For Stage 2 participants, achievement of developmental milestones was planned to be assessed using the ACH developmental recording form. This form allows developmental milestones to be recorded and was not a formalized screening tool or assessment. The form measures the domains of gross motor function, fine motor function, communication and feeding via participant reports to the Investigator. The form depicts the cumulative percentage distributions for children with ACH for each item as well as norms for reference based on the Denver II test, where available. Data collected via this form was planned to be evaluated descriptively to explore the age at which participants in this study achieve developmental milestones. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Week 52
Stage 1: Plasma Concentration of SAR442501
Prazo: Pre-dose and 6, 24 and 72 hours post dose on Day 1; Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
Blood samples are collected to determine plasma concentration of SAR442501.
Pre-dose and 6, 24 and 72 hours post dose on Day 1; Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
Stage 1: Maximum Observed Plasma Concentration (Cmax) of SAR442501
Prazo: Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
Blood samples are collected to determine Cmax of SAR442501. The Cmax of SAR442501 was calculated using non-compartmental method.
Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
Stage 1: Time to Reach the Maximum Concentration (Tmax) of SAR442501
Prazo: Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
Blood samples are collected to determine tmax of SAR442501. The tmax of SAR442501 was calculated using non-compartmental method.
Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
Stage 1: Area Under the Concentration Versus Time Curve From Time 0 to 72 Hours After Study Drug Administration (AUC0-tau) of SAR442501
Prazo: Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
Blood samples are collected to determine AUC0-tau of SAR442501. The AUC0-tau of SAR442501 was calculated using non-compartmental method.
Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
Stage 1: Minimum Plasma Concentration (Ctrough) of SAR442501
Prazo: Pre-dose on Days 8, 29, 57, 92, 183, 274, 365 and 449
Blood samples are collected to determine Ctrough of SAR442501. The Ctrough of SAR442501 was calculated using non-compartmental method.
Pre-dose on Days 8, 29, 57, 92, 183, 274, 365 and 449
Stage 1: Change From Baseline to Week 26 in Collagen X Biomarker (CXM) Level
Prazo: Baseline (Day 1) and Week 26
Serum samples were collected to assess the change in CXM level with study drug. The CXM was also named PRO-C10 because the biomarker assay used was aimed to target the recognition of the C terminus of the NC1 domain of type X collagen. The baseline value was defined as the last available value before the first dose of study drug. Change from baseline in CXM level has been reported.
Baseline (Day 1) and Week 26
Stage 1: Change From Baseline to Weeks 26 and 52 in Osteocalcin Level
Prazo: Baseline (Day 1) and Weeks 26 and 52
Serum samples were collected to assess the change in osteocalcin level with study drug. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Bone-Specific Alkaline Phosphatase Level
Prazo: Baseline (Day 1) and Weeks 26 and 52
Serum samples were collected to assess the change in bone-specific alkaline phosphatase level with study drug. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Procollagen Type 1 N-Terminal Propeptide (P1NP) Level
Prazo: Baseline (Day 1) and Weeks 26 and 52
Serum samples were collected to assess the change in P1NP level with study drug. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Change From Baseline to Weeks 26 and 52 in Collagen-Type 1 C-Telopeptide (CTX) Level
Prazo: Baseline (Day 1) and Weeks 26 and 52
Serum samples were collected to assess the change in CTX level with study drug. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52
Stage 1: Number of Participants With Anti-drug Antibodies (ADA) to SAR442501
Prazo: From the first dose of study drug administration (Day 1) up to early termination of the study, approximately 58 weeks (Stage 1: SAR442501 Dose A) and 46 weeks (Stage 1: SAR442501 Dose B)
Serum samples were collected to assess the antibodies to SAR442501. Samples were screened and then confirmed for antibodies binding to SAR442501 and the titer of confirmed positive samples were reported. Positive ADA refers to pre-existing ADA at the pre-dose assessment on Day 1.
From the first dose of study drug administration (Day 1) up to early termination of the study, approximately 58 weeks (Stage 1: SAR442501 Dose A) and 46 weeks (Stage 1: SAR442501 Dose B)
Stage 2: Number of Participants With Change From Baseline to Weeks 26 and 52 in Neurological Examination Findings
Prazo: Baseline (Day 1) and Weeks 26 and 52
A complete neurological examination included assessment of mental status, motor function and balance, sensory exam, newborn and infant reflexes, muscle stretch reflexes in the older children and evaluation of the cranial nerves. The baseline value was defined as the last available value before the first dose of study drug.
Baseline (Day 1) and Weeks 26 and 52

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Sanofi

Investigadores

  • Diretor de estudo: Clinical Sciences & Operations, Sanofi

Publicações e links úteis

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Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

10 de outubro de 2023

Conclusão Primária (Real)

12 de fevereiro de 2025

Conclusão do estudo (Real)

12 de fevereiro de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

20 de setembro de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de setembro de 2023

Primeira postagem (Real)

4 de outubro de 2023

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de junho de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • DRI16646
  • U1111-1280-5374 (Identificador de registro: ICTRP)
  • 2023-503677-37 (Identificador de registro: CTIS)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Pesquisadores qualificados podem solicitar acesso aos dados do paciente e aos documentos de estudo relacionados, incluindo o relatório do estudo clínico, o protocolo do estudo com quaisquer alterações, o formulário de relatório de caso em branco, o plano de análise estatística e as especificações do conjunto de dados. Os dados do paciente serão anonimizados e os documentos do estudo serão redigidos para proteger a privacidade dos participantes do estudo. Mais detalhes sobre os critérios de compartilhamento de dados da Sanofi, estudos elegíveis e processo para solicitação de acesso podem ser encontrados em: https://vivli.org

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

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Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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