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Innocuité, tolérance, pharmacocinétique, pharmacodynamique et efficacité du SAR442501 chez les participants pédiatriques atteints d'achondroplasie (upreACH-2)

1 juin 2026 mis à jour par: Sanofi

Une étude de phase 2, ouverte, multicentrique, de cohorte séquentielle en 2 étapes, avec augmentation de la dose, pour évaluer l'innocuité, la tolérance, la pharmacocinétique, la pharmacodynamique et l'efficacité du SAR442501 sous-cutané chez les participants pédiatriques atteints d'achondroplasie

Il s'agit d'une étude de phase 2, ouverte et multicentrique visant à évaluer l'innocuité, la tolérabilité et l'efficacité du SAR442501 chez les enfants de la naissance jusqu'à 12 ans atteints d'achondroplasie.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Description détaillée

Jusqu'à environ 275 semaines : 3 semaines de dépistage + 52 semaines de période de traitement primaire + jusqu'à environ 216 semaines de période de traitement prolongée + 4 semaines de suivi.

Type d'étude

Interventionnel

Inscription (Réel)

16

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Australie
    • Victoria
      • Parkville, Victoria, Australie, 3052
        • Investigational Site Number : 0360001
  • Chine
      • Shanghai, Chine, 200120
        • Investigational Site Number : 1560002
      • Wuhan, Chine, 430030
        • Investigational Site Number : 1560001
  • Corée du Sud
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, Corée du Sud, 03080
        • Investigational Site Number : 4100001
      • Seoul, Seoul-teukbyeolsi, Corée du Sud, 06351
        • Investigational Site Number : 4100002
  • Espagne
    • Basque Country
      • Vitoria-Gasteiz, Basque Country, Espagne, 01008
        • Investigational Site Number : 7240002
    • Catalunya [Cataluña]
      • Esplugues de Llobregat, Catalunya [Cataluña], Espagne, 08950
        • Investigational Site Number : 7240001
  • Italie
    • Lombardy
      • Milan, Lombardy, Italie, 20122
        • Investigational Site Number : 3800002
    • Roma
      • Rome, Roma, Italie, 00168
        • Investigational Site Number : 3800001

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Non

La description

Critère d'intégration:

  • Les participants doivent avoir ACH avec une mutation confirmée du gène FGFR3
  • Les participants et/ou leurs parents ou représentants légaux doivent être disposés et capables d'effectuer toutes les procédures de l'étude au mieux de leurs capacités physiques.
  • Parent(s) ou représentant(s) légal(s) capable(s) de donner un consentement éclairé signé et participants capables de donner leur assentiment, le cas échéant.

Critère d'exclusion:

  • Vous souffrez d'hypochondroplasie (ou de mutation N540K) ou d'une petite taille autre que l'ACH (par exemple, trisomie 21, pseudochondroplasie)
  • Les participants ont reçu n'importe quelle dose de médicaments ou de produits expérimentaux, y compris l'hormone de croissance humaine, destinée à affecter la stature ou les proportions corporelles des participants dans les 6 mois suivant l'inscription (semaine 0/jour 1/visite 2).
  • avez des antécédents de fermeture du cartilage de croissance.
  • Fracture des os longs dans les 3 mois suivant l'inscription (semaine 0/jour 1/visite 2)
  • Preuve actuelle de trouble/kératopathie cornéenne ou rétinienne.
  • Les participants ont déjà subi une intervention chirurgicale impliquant le foramen magnum (stade 2 uniquement).
  • Hyperphosphatémie.

Les informations ci-dessus ne sont pas destinées à contenir toutes les considérations pertinentes à une participation potentielle à un essai clinique.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Cohorte 1
Médicament: SAR442501
Solution injectable ; Injection sous-cutanée
Expérimental: Cohorte 2
Médicament: SAR442501
Solution injectable ; Injection sous-cutanée
Expérimental: Cohorte 3
Médicament: SAR442501
Solution injectable ; Injection sous-cutanée

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Stage 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Stage 1: Change From Baseline to Weeks 26 and 52 in Growth Velocity Z-Score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Sanofi

Les enquêteurs

  • Directeur d'études: Clinical Sciences & Operations, Sanofi

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 octobre 2023

Achèvement primaire (Réel)

12 février 2025

Achèvement de l'étude (Réel)

12 février 2025

Dates d'inscription aux études

Première soumission

20 septembre 2023

Première soumission répondant aux critères de contrôle qualité

28 septembre 2023

Première publication (Réel)

4 octobre 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juin 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • DRI16646
  • U1111-1280-5374 (Identificateur de registre: ICTRP)
  • 2023-503677-37 (Identificateur de registre: CTIS)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Les chercheurs qualifiés peuvent demander l'accès aux données sur les patients et aux documents d'étude associés, notamment le rapport d'étude clinique, le protocole d'étude avec toutes modifications, le formulaire de rapport de cas vierge, le plan d'analyse statistique et les spécifications de l'ensemble de données. Les données au niveau des patients seront anonymisées et les documents de l'étude seront rédigés pour protéger la vie privée des participants à l'essai. De plus amples détails sur les critères de partage de données de Sanofi, les études éligibles et le processus de demande d'accès sont disponibles sur : https://vivli.org

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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