연골 무형성증이 있는 소아 참가자에 대한 SAR442501의 안전성, 내약성, 약동학, 약력학 및 효능 (upreACH-2)
2026년 6월 1일 업데이트: Sanofi
연골 무형성증이 있는 소아 참가자를 대상으로 피하 SAR442501의 안전성, 내약성, 약동학, 약력학 및 효능을 평가하기 위한 2상, 공개, 다기관, 2단계 순차적 코호트, 용량 증량 연구
이는 연골 무형성증을 앓고 있는 출생부터 12세까지의 어린이를 대상으로 SAR442501의 안전성, 내약성 및 효능을 평가하기 위한 2상, 공개 라벨, 다기관 연구입니다.
연구 개요
상세 설명
최대 약 275주: 3주 스크리닝 + 52주 1차 치료 기간 + 최대 약 216주 연장 치료 기간 + 4주 추적 관찰.
연구 유형
중재적
등록 (실제)
16
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Seoul-teukbyeolsi
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Seoul, Seoul-teukbyeolsi, 대한민국, 03080
- Investigational Site Number : 4100001
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Seoul, Seoul-teukbyeolsi, 대한민국, 06351
- Investigational Site Number : 4100002
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Basque Country
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Vitoria-Gasteiz, Basque Country, 스페인, 01008
- Investigational Site Number : 7240002
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Catalunya [Cataluña]
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Esplugues de Llobregat, Catalunya [Cataluña], 스페인, 08950
- Investigational Site Number : 7240001
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Lombardy
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Milan, Lombardy, 이탈리아, 20122
- Investigational Site Number : 3800002
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Roma
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Rome, Roma, 이탈리아, 00168
- Investigational Site Number : 3800001
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Shanghai, 중국, 200120
- Investigational Site Number : 1560002
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Wuhan, 중국, 430030
- Investigational Site Number : 1560001
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Victoria
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Parkville, Victoria, 호주, 3052
- Investigational Site Number : 0360001
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- 참가자는 FGFR3 유전자에 돌연변이가 확인된 ACH가 있어야 합니다.
- 참가자 및/또는 부모 또는 법적 대리인은 신체적 능력을 최대한 활용하여 모든 연구 절차를 수행할 의지와 능력이 있어야 합니다.
- 서명된 사전 동의를 제공할 수 있는 부모 또는 법적 대리인과 해당되는 경우 동의를 제공할 수 있는 참가자.
제외 기준:
- 저연골무형성증(또는 N540K 돌연변이) 또는 ACH 이외의 저신장 질환(예: 21번 삼염색체증, 가성연골무형성증)이 있는 경우
- 참가자는 등록 후 6개월(0주차/1일차/방문 2차) 이내에 참가자의 키 또는 신체 비율에 영향을 미치도록 의도된 인간 성장 호르몬을 포함하여 모든 용량의 약물 또는 조사 제품을 투여받았습니다.
- 성장판 폐쇄 병력이 있습니다.
- 등록 후 3개월 이내 장골 골절(0주차/1일차/2차 방문)
- 각막 또는 망막 장애/각막병증의 현재 증거.
- 참가자는 이전에 대공과 관련된 수술적 개입을 받은 적이 있습니다(2단계만 해당).
- 고인산혈증.
위의 정보는 임상 시험의 잠재적 참여와 관련된 모든 고려 사항을 포함하려는 의도가 아닙니다.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 코호트 1
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주입용 용액; 피하 주사
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실험적: 코호트 2
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주입용 용액; 피하 주사
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실험적: 코호트 3
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주입용 용액; 피하 주사
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Stage 1: Change From Baseline to Weeks 26 and 52 in Growth Velocity Z-Score
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: Clinical Sciences & Operations, Sanofi
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2023년 10월 10일
기본 완료 (실제)
2025년 2월 12일
연구 완료 (실제)
2025년 2월 12일
연구 등록 날짜
최초 제출
2023년 9월 20일
QC 기준을 충족하는 최초 제출
2023년 9월 28일
처음 게시됨 (실제)
2023년 10월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 1일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- DRI16646
- U1111-1280-5374 (레지스트리 식별자: ICTRP)
- 2023-503677-37 (레지스트리 식별자: CTIS)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
자격을 갖춘 연구자는 임상 연구 보고서, 수정 사항이 포함된 연구 프로토콜, 백지 사례 보고서 양식, 통계 분석 계획 및 데이터 세트 사양을 포함하여 환자 수준 데이터 및 관련 연구 문서에 대한 액세스를 요청할 수 있습니다.
환자 수준 데이터는 익명화되며 연구 문서는 임상시험 참가자의 개인정보를 보호하기 위해 수정됩니다.
Sanofi의 데이터 공유 기준, 적격 연구 및 액세스 요청 프로세스에 대한 자세한 내용은 https://vivli.org에서 확인할 수 있습니다.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .