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Bezpieczeństwo, tolerancja, farmakokinetyka, farmakodynamika i skuteczność SAR442501 u dzieci i młodzieży z achondroplazją (upreACH-2)

1 czerwca 2026 zaktualizowane przez: Sanofi

Faza 2, otwarte, wieloośrodkowe, 2-etapowe, sekwencyjne badanie kohortowe, badanie ze zwiększaniem dawki w celu oceny bezpieczeństwa, tolerancji, farmakokinetyki, farmakodynamiki i skuteczności podawanego podskórnie SAR442501 u dzieci i młodzieży z achondroplazją

Jest to otwarte, wieloośrodkowe badanie fazy II, mające na celu ocenę bezpieczeństwa, tolerancji i skuteczności SAR442501 u dzieci od urodzenia do 12 lat z achondroplazją.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

Do około 275 tygodni: 3 tygodnie badania przesiewowego + 52 tygodnie okresu leczenia podstawowego + do około 216 tygodni przedłużonego okresu leczenia + 4 tygodnie obserwacji.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

16

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Australia
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Investigational Site Number : 0360001
  • Chiny
      • Shanghai, Chiny, 200120
        • Investigational Site Number : 1560002
      • Wuhan, Chiny, 430030
        • Investigational Site Number : 1560001
  • Hiszpania
    • Basque Country
      • Vitoria-Gasteiz, Basque Country, Hiszpania, 01008
        • Investigational Site Number : 7240002
    • Catalunya [Cataluña]
      • Esplugues de Llobregat, Catalunya [Cataluña], Hiszpania, 08950
        • Investigational Site Number : 7240001
  • Korea Południowa
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, Korea Południowa, 03080
        • Investigational Site Number : 4100001
      • Seoul, Seoul-teukbyeolsi, Korea Południowa, 06351
        • Investigational Site Number : 4100002
  • Włochy
    • Lombardy
      • Milan, Lombardy, Włochy, 20122
        • Investigational Site Number : 3800002
    • Roma
      • Rome, Roma, Włochy, 00168
        • Investigational Site Number : 3800001

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko

Akceptuje zdrowych ochotników

Nie

Opis

Kryteria przyjęcia:

  • Uczestnicy muszą mieć ACH z potwierdzoną mutacją w genie FGFR3
  • Uczestnicy i/lub rodzice lub przedstawiciele prawni muszą chcieć i być w stanie przeprowadzić wszystkie procedury badawcze najlepiej jak potrafią.
  • Rodzice lub przedstawiciele prawni mogący wyrazić podpisaną świadomą zgodę oraz uczestnicy mogący wyrazić zgodę, jeśli ma to zastosowanie.

Kryteria wyłączenia:

  • Masz hipochondroplazję (lub mutację N540K) lub niski wzrost inny niż ACH (np. trisomia 21, pseudochondroplazja)
  • Uczestnicy otrzymali dowolną dawkę leków lub badanego produktu, w tym ludzkiego hormonu wzrostu, mających wpłynąć na wzrost lub proporcje ciała uczestników w ciągu 6 miesięcy od włączenia do badania (tydzień 0/dzień 1/wizyta 2).
  • Mają historię zamykania płytki wzrostu.
  • Złamanie kości długich w ciągu 3 miesięcy od włączenia do badania (tydzień 0/dzień 1/wizyta 2)
  • Aktualne dowody na zaburzenie/keratopatię rogówki lub siatkówki.
  • Uczestnicy przeszli wcześniej interwencję chirurgiczną obejmującą otwór wielki (tylko etap 2).
  • Hiperfosfatemia.

Powyższe informacje nie mają na celu uwzględnienia wszystkich rozważań istotnych dla potencjalnego udziału w badaniu klinicznym.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Kohorta 1
Lek: SAR442501
Roztwór do wstrzykiwań; Wstrzyknięcie podskórne
Eksperymentalny: Kohorta 2
Lek: SAR442501
Roztwór do wstrzykiwań; Wstrzyknięcie podskórne
Eksperymentalny: Kohorta 3
Lek: SAR442501
Roztwór do wstrzykiwań; Wstrzyknięcie podskórne

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Stage 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Stage 1: Change From Baseline to Weeks 26 and 52 in Growth Velocity Z-Score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Sanofi

Śledczy

  • Dyrektor Studium: Clinical Sciences & Operations, Sanofi

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

10 października 2023

Zakończenie podstawowe (Rzeczywisty)

12 lutego 2025

Ukończenie studiów (Rzeczywisty)

12 lutego 2025

Daty rejestracji na studia

Pierwszy przesłany

20 września 2023

Pierwszy przesłany, który spełnia kryteria kontroli jakości

28 września 2023

Pierwszy wysłany (Rzeczywisty)

4 października 2023

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

25 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 czerwca 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • DRI16646
  • U1111-1280-5374 (Identyfikator rejestru: ICTRP)
  • 2023-503677-37 (Identyfikator rejestru: CTIS)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Wykwalifikowani badacze mogą poprosić o dostęp do danych na poziomie pacjenta i powiązanych dokumentów badawczych, w tym raportu z badania klinicznego, protokołu badania ze wszystkimi poprawkami, pustego formularza raportu przypadku, planu analizy statystycznej i specyfikacji zbioru danych. Dane na poziomie pacjenta zostaną zanonimizowane, a dokumenty badania zostaną zredagowane w celu ochrony prywatności uczestników badania. Więcej szczegółów na temat kryteriów udostępniania danych przez firmę Sanofi, kwalifikujących się badań i procesu składania wniosku o dostęp można znaleźć na stronie: https://vivli.org

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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