Bezpečnost, snášenlivost, farmakokinetika, farmakodynamika a účinnost SAR442501 u pediatrických účastníků s achondroplázií (upreACH-2)
1. června 2026 aktualizováno: Sanofi
Fáze 2, otevřená, multicentrická, 2stupňová sekvenční kohorta, studie s eskalací dávek k posouzení bezpečnosti, snášenlivosti, farmakokinetiky, farmakodynamiky a účinnosti subkutánní SAR442501 u pediatrických účastníků s achondroplázií
Toto je otevřená, multicentrická studie fáze 2, která hodnotí bezpečnost, snášenlivost a účinnost SAR442501 u dětí od narození do 12 let s achondroplázií.
Přehled studie
Detailní popis
Až přibližně 275 týdnů: 3 týdny Screening + 52 týdnů primární období léčby + až přibližně 216 týdnů prodloužené období léčby + 4 týdny následného sledování.
Typ studie
Intervenční
Zápis (Aktuální)
16
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Victoria
-
Parkville, Victoria, Austrálie, 3052
- Investigational Site Number : 0360001
-
-
-
-
Lombardy
-
Milan, Lombardy, Itálie, 20122
- Investigational Site Number : 3800002
-
-
Roma
-
Rome, Roma, Itálie, 00168
- Investigational Site Number : 3800001
-
-
-
-
Seoul-teukbyeolsi
-
Seoul, Seoul-teukbyeolsi, Jižní Korea, 03080
- Investigational Site Number : 4100001
-
Seoul, Seoul-teukbyeolsi, Jižní Korea, 06351
- Investigational Site Number : 4100002
-
-
-
-
-
Shanghai, Čína, 200120
- Investigational Site Number : 1560002
-
Wuhan, Čína, 430030
- Investigational Site Number : 1560001
-
-
-
-
Basque Country
-
Vitoria-Gasteiz, Basque Country, Španělsko, 01008
- Investigational Site Number : 7240002
-
-
Catalunya [Cataluña]
-
Esplugues de Llobregat, Catalunya [Cataluña], Španělsko, 08950
- Investigational Site Number : 7240001
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Ne
Popis
Kritéria pro zařazení:
- Účastníci musí mít ACH s potvrzenou mutací v genu FGFR3
- Účastníci a/nebo rodiče nebo zákonní zástupci musí být ochotni a schopni provádět všechny studijní postupy podle svých nejlepších fyzických schopností.
- Rodiče nebo zákonní zástupci schopní dát podepsaný informovaný souhlas a účastníci schopní dát souhlas, pokud je to možné.
Kritéria vyloučení:
- Máte hypochondroplazii (nebo mutaci N540K) nebo stav malého vzrůstu jiný než ACH (např. trizomie 21, pseudochondroplazie)
- Účastníci obdrželi jakoukoli dávku léků nebo zkoumaného produktu, včetně lidského růstového hormonu, které mají ovlivnit postavu nebo tělesné proporce účastníků do 6 měsíců od přihlášení (týden 0/den 1/2. návštěva).
- Mít v anamnéze uzavření růstové ploténky.
- Zlomenina dlouhé kosti do 3 měsíců od zápisu (týden 0/den 1/návštěva 2)
- Současné známky onemocnění rohovky nebo sítnice/keratopatie.
- Účastníci podstoupili předchozí chirurgický zákrok zahrnující foramen magnum (pouze fáze 2).
- Hyperfosfatemie.
Výše uvedené informace nejsou určeny k tomu, aby obsahovaly všechny úvahy relevantní pro potenciální účast v klinickém hodnocení.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Kohorta 1
|
Injekční roztok; Subkutánní injekce
|
|
Experimentální: Kohorta 2
|
Injekční roztok; Subkutánní injekce
|
|
Experimentální: Kohorta 3
|
Injekční roztok; Subkutánní injekce
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Stage 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Stage 1: Change From Baseline to Weeks 26 and 52 in Growth Velocity Z-Score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Ředitel studie: Clinical Sciences & Operations, Sanofi
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
10. října 2023
Primární dokončení (Aktuální)
12. února 2025
Dokončení studie (Aktuální)
12. února 2025
Termíny zápisu do studia
První předloženo
20. září 2023
První předloženo, které splnilo kritéria kontroly kvality
28. září 2023
První zveřejněno (Aktuální)
4. října 2023
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
25. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
1. června 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- DRI16646
- U1111-1280-5374 (Identifikátor registru: ICTRP)
- 2023-503677-37 (Identifikátor registru: CTIS)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Kvalifikovaní výzkumní pracovníci mohou požádat o přístup k údajům na úrovni pacientů a souvisejícím dokumentům studie, včetně zprávy o klinické studii, protokolu studie s případnými dodatky, prázdného formuláře zprávy o případu, plánu statistické analýzy a specifikací datové sady.
Údaje na úrovni pacientů budou anonymizovány a studijní dokumenty budou redigovány, aby bylo chráněno soukromí účastníků studie.
Další podrobnosti o kritériích sdílení dat společnosti Sanofi, způsobilých studiích a procesu žádosti o přístup lze nalézt na: https://vivli.org
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .