Sicurezza, tollerabilità, farmacocinetica, farmacodinamica ed efficacia di SAR442501 in partecipanti pediatrici con acondroplasia (upreACH-2)
1 giugno 2026 aggiornato da: Sanofi
Uno studio di coorte sequenziale di fase 2, in aperto, multicentrico, in 2 fasi, con incremento della dose per valutare la sicurezza, la tollerabilità, la farmacocinetica, la farmacodinamica e l'efficacia del SAR442501 sottocutaneo in partecipanti pediatrici con acondroplasia
Si tratta di uno studio di Fase 2, in aperto, multicentrico, volto a valutare la sicurezza, la tollerabilità e l'efficacia di SAR442501 nei bambini dalla nascita fino a 12 anni affetti da acondroplasia.
Panoramica dello studio
Stato
Stato
Terminato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Fino a circa 275 settimane: 3 settimane di screening + 52 settimane di periodo di trattamento primario + fino a circa 216 settimane di periodo di trattamento esteso + 4 settimane di follow-up.
Tipo di studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
Iscrizione
16
Fase
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
Contatto studio
- Nome: Trial Transparency email recommended (Toll free for US & Canada)
- Numero di telefono: option 6 800-633-1610
- Email: contact-us@sanofi.com
Luoghi di studio
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Victoria
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Parkville, Victoria, Australia, 3052
- Investigational Site Number : 0360001
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Shanghai, Cina, 200120
- Investigational Site Number : 1560002
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Wuhan, Cina, 430030
- Investigational Site Number : 1560001
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Seoul-teukbyeolsi
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Seoul, Seoul-teukbyeolsi, Corea del Sud, 03080
- Investigational Site Number : 4100001
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Seoul, Seoul-teukbyeolsi, Corea del Sud, 06351
- Investigational Site Number : 4100002
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Lombardy
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Milan, Lombardy, Italia, 20122
- Investigational Site Number : 3800002
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Roma
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Rome, Roma, Italia, 00168
- Investigational Site Number : 3800001
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Basque Country
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Vitoria-Gasteiz, Basque Country, Spagna, 01008
- Investigational Site Number : 7240002
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Catalunya [Cataluña]
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Esplugues de Llobregat, Catalunya [Cataluña], Spagna, 08950
- Investigational Site Number : 7240001
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
No
Descrizione
Criterio di inclusione:
- I partecipanti devono avere ACH con una mutazione confermata nel gene FGFR3
- I partecipanti e/o i genitori o i rappresentanti legali devono essere disposti e in grado di eseguire tutte le procedure dello studio al meglio delle proprie capacità fisiche.
- Genitori o rappresentanti legali in grado di dare il consenso informato firmato e partecipanti in grado di dare il consenso quando applicabile.
Criteri di esclusione:
- Avere ipocondroplasia (o mutazione N540K) o condizione di bassa statura diversa dall'ACH (p. es., trisomia 21, pseudocondroplasia)
- I partecipanti hanno ricevuto qualsiasi dose di farmaci o prodotti sperimentali, compreso l'ormone umano della crescita, destinati a influenzare la statura o le proporzioni corporee dei partecipanti entro 6 mesi dall'iscrizione (Settimana 0/Giorno 1/Visita 2).
- Avere una storia di chiusura della cartilagine di crescita.
- Frattura delle ossa lunghe entro 3 mesi dall'arruolamento (Settimana 0/Giorno 1/Visita 2)
- Evidenza attuale di disturbo/cheratopatia corneale o retinica.
- I partecipanti hanno subito un precedente intervento chirurgico che ha coinvolto il forame magno (solo Fase 2).
- Iperfosfatemia.
Le informazioni di cui sopra non intendono contenere tutte le considerazioni rilevanti per una potenziale partecipazione a una sperimentazione clinica.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
3
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: Coorte 1
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Soluzione iniettabile; Iniezione sottocutanea
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Sperimentale: Coorte 2
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Soluzione iniettabile; Iniezione sottocutanea
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Sperimentale: Coorte 3
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Soluzione iniettabile; Iniezione sottocutanea
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Stage 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Lasso di tempo: 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)
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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.
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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)
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Stage 1: Change From Baseline to Weeks 26 and 52 in Growth Velocity Z-Score
Lasso di tempo: Baseline (Day 1) and Weeks 26 and 52
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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.
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Baseline (Day 1) and Weeks 26 and 52
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Stage 1: Change From Baseline to Weeks 26 and 52 in Annualized Growth Velocity
Lasso di tempo: Baseline (Day 1) and Weeks 26 and 52
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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.
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Baseline (Day 1) and Weeks 26 and 52
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Stage 1: Change From Baseline to Weeks 26 and 52 in Height Z-Score
Lasso di tempo: Baseline (Day 1) and Weeks 26 and 52
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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.
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Baseline (Day 1) and Weeks 26 and 52
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Stage 1: Change From Baseline to Weeks 26 and 52 in Upper to Lower Body Segment Ratio
Lasso di tempo: Baseline (Day 1) and Weeks 26 and 52
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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.
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Baseline (Day 1) and Weeks 26 and 52
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Stage 1: Change From Baseline to Weeks 26 and 52 in Upper to Lower Extremity Ratio
Lasso di tempo: Baseline (Day 1) and Weeks 26 and 52
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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.
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Baseline (Day 1) and Weeks 26 and 52
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Stage 1: Change From Baseline to Weeks 26 and 52 in Sitting to Standing Height Ratio
Lasso di tempo: Baseline (Day 1) and Weeks 26 and 52
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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.
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Baseline (Day 1) and Weeks 26 and 52
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Stage 1: Change From Baseline to Weeks 26 and 52 in Arm Span to Height Ratio
Lasso di tempo: Baseline (Day 1) and Weeks 26 and 52
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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.
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Baseline (Day 1) and Weeks 26 and 52
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Stage 1: Change From Baseline to Weeks 26 and 52 in Upper Arm to Forearm Length Ratio
Lasso di tempo: Baseline (Day 1) and Weeks 26 and 52
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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.
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Baseline (Day 1) and Weeks 26 and 52
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Stage 1: Change From Baseline to Weeks 26 and 52 in Upper Leg to Lower Leg Ratio
Lasso di tempo: Baseline (Day 1) and Weeks 26 and 52
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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.
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Baseline (Day 1) and Weeks 26 and 52
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Stage 1: Change From Baseline to Weeks 26 and 52 in Head Circumference to Height Ratio
Lasso di tempo: Baseline (Day 1) and Weeks 26 and 52
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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.
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Baseline (Day 1) and Weeks 26 and 52
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Stage 2: Change From Baseline to Week 52 in Brainstem, Skull, and Spine Morphometric and Volumetric Parameters
Lasso di tempo: Baseline (Day 1) and Week 52
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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.
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Baseline (Day 1) and Week 52
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Stage 1: Change From Baseline to Weeks 26 and 52 in Social Score, Emotional Score, and School Functioning Score
Lasso di tempo: Baseline (Day 1) and Weeks 26 and 52
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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.
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Baseline (Day 1) and Weeks 26 and 52
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Stage 1: Change From Baseline to Weeks 26 and 52 in Psychosocial Health Summary Score, Physical Health Summary Score, and Total Score
Lasso di tempo: Baseline (Day 1) and Weeks 26 and 52
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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.
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Baseline (Day 1) and Weeks 26 and 52
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Stage 1: Change From Baseline to Weeks 26 and 52 in Mobility Score
Lasso di tempo: Baseline (Day 1) and Weeks 26 and 52
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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.
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Baseline (Day 1) and Weeks 26 and 52
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Stage 1: Change From Baseline to Weeks 26 and 52 in Participants Reported Symptoms
Lasso di tempo: Baseline (Day 1) and Weeks 26 and 52
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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.
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Baseline (Day 1) and Weeks 26 and 52
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Stage 1: Change From Baseline to Weeks 26 and 52 in General Fatigue, Sleep/Rest Fatigue and Cognitive Fatigue Scores and Total Score
Lasso di tempo: Baseline (Day 1) and Weeks 26 and 52
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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.
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Baseline (Day 1) and Weeks 26 and 52
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Stage 1: Change From Baseline to Weeks 26 and 52 in Current Pain and Worst Pain Rating (PPQ) Score
Lasso di tempo: Baseline (Day 1) and Weeks 26 and 52
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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.
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Baseline (Day 1) and Weeks 26 and 52
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Stage 2: Change From Baseline to Week 52 in Achievement of Gross Motor, Fine Motor, Communication, and Feeding Milestones
Lasso di tempo: Baseline (Day 1) and Week 52
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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.
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Baseline (Day 1) and Week 52
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Stage 1: Plasma Concentration of SAR442501
Lasso di tempo: 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
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Blood samples are collected to determine plasma concentration of SAR442501.
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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
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Stage 1: Maximum Observed Plasma Concentration (Cmax) of SAR442501
Lasso di tempo: Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
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Blood samples are collected to determine Cmax of SAR442501.
The Cmax of SAR442501 was calculated using non-compartmental method.
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Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
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Stage 1: Time to Reach the Maximum Concentration (Tmax) of SAR442501
Lasso di tempo: Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
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Blood samples are collected to determine tmax of SAR442501.
The tmax of SAR442501 was calculated using non-compartmental method.
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Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
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Stage 1: Area Under the Concentration Versus Time Curve From Time 0 to 72 Hours After Study Drug Administration (AUC0-tau) of SAR442501
Lasso di tempo: Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
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Blood samples are collected to determine AUC0-tau of SAR442501.
The AUC0-tau of SAR442501 was calculated using non-compartmental method.
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Pre-dose and 3, 6, 12, 24 and 72 hours post dose on Day 57
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Stage 1: Minimum Plasma Concentration (Ctrough) of SAR442501
Lasso di tempo: Pre-dose on Days 8, 29, 57, 92, 183, 274, 365 and 449
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Blood samples are collected to determine Ctrough of SAR442501.
The Ctrough of SAR442501 was calculated using non-compartmental method.
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Pre-dose on Days 8, 29, 57, 92, 183, 274, 365 and 449
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Stage 1: Change From Baseline to Week 26 in Collagen X Biomarker (CXM) Level
Lasso di tempo: Baseline (Day 1) and Week 26
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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.
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Baseline (Day 1) and Week 26
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Stage 1: Change From Baseline to Weeks 26 and 52 in Osteocalcin Level
Lasso di tempo: Baseline (Day 1) and Weeks 26 and 52
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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.
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Baseline (Day 1) and Weeks 26 and 52
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Stage 1: Change From Baseline to Weeks 26 and 52 in Bone-Specific Alkaline Phosphatase Level
Lasso di tempo: Baseline (Day 1) and Weeks 26 and 52
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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.
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Baseline (Day 1) and Weeks 26 and 52
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Stage 1: Change From Baseline to Weeks 26 and 52 in Procollagen Type 1 N-Terminal Propeptide (P1NP) Level
Lasso di tempo: Baseline (Day 1) and Weeks 26 and 52
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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.
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Baseline (Day 1) and Weeks 26 and 52
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Stage 1: Change From Baseline to Weeks 26 and 52 in Collagen-Type 1 C-Telopeptide (CTX) Level
Lasso di tempo: Baseline (Day 1) and Weeks 26 and 52
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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.
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Baseline (Day 1) and Weeks 26 and 52
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Stage 1: Number of Participants With Anti-drug Antibodies (ADA) to SAR442501
Lasso di tempo: 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)
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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.
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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)
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Stage 2: Number of Participants With Change From Baseline to Weeks 26 and 52 in Neurological Examination Findings
Lasso di tempo: Baseline (Day 1) and Weeks 26 and 52
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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.
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Baseline (Day 1) and Weeks 26 and 52
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Investigatori
Investigatori
- Direttore dello studio: Clinical Sciences & Operations, Sanofi
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
10 ottobre 2023
Completamento primario (Effettivo)
Completamento primario
12 febbraio 2025
Completamento dello studio (Effettivo)
Completamento dello studio
12 febbraio 2025
Date di iscrizione allo studio
Primo inviato
Primo inviato
20 settembre 2023
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
28 settembre 2023
Primo Inserito (Effettivo)
Primo Inserito
4 ottobre 2023
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
25 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 giugno 2026
Ultimo verificato
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- DRI16646
- U1111-1280-5374 (Identificatore di registro: ICTRP)
- 2023-503677-37 (Identificatore di registro: CTIS)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
I ricercatori qualificati possono richiedere l'accesso ai dati a livello del paziente e ai relativi documenti di studio, tra cui il rapporto dello studio clinico, il protocollo dello studio con eventuali modifiche, il modulo vuoto del rapporto del caso, il piano di analisi statistica e le specifiche del set di dati.
I dati a livello del paziente verranno resi anonimi e i documenti dello studio verranno oscurati per proteggere la privacy dei partecipanti allo studio.
Ulteriori dettagli sui criteri di condivisione dei dati di Sanofi, sugli studi ammissibili e sulla procedura per richiedere l'accesso sono disponibili all'indirizzo: https://vivli.org
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .