다년생 알레르기성 비염 성인 참가자를 대상으로 한 레브리키주맙 연구(준비-1)
다년생 알레르기성 비염을 앓고 있는 성인 참가자를 대상으로 Lebrikizumab/LY3650150의 효능과 안전성을 평가하기 위한 3상, 다기관, 무작위 배정, 이중 맹검, 위약 대조, 병렬 그룹 연구
The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis.
Participants can expect study participation to last up to 29.5 months.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 3단계
연락처 및 위치
연구 장소
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Busan, 대한민국, 48108
- Inje University Haeundae Paik Hospital
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Incheon, 대한민국, 21565
- B1F, Pharmacy department, Gachon University Gil Medical Center
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Seongnam-si, 대한민국, 13620
- Seoul National University Bundang Hospital
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Seoul, 대한민국, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, 대한민국, 05278
- Kyunghee University Hospital at Gangdong
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Seoul, 대한민국, 6273
- Gangnam Severance Hospital 211
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Seoul, 대한민국, 7061
- SMG-SNU Boramae Medical Center
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Seoul, 대한민국, 8308
- Clinical trial Pharmacy
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Berlin, 독일, 10117
- Charité - Universitätsmedizin Berlin Klinik für Dermatologie
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Dresden, 독일, 1307
- Universitätsklinikum Carl Gustav Carus an der TU
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Dresden, 독일, 1139
- Praxis für HNO und Allergologie
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Frankfurt am Main, 독일, 60596
- IKF Pneumologie
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Heidelberg, 독일, 69115
- Siteworks - Zentrum für klinische Studien Heidelberg
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Marburg, 독일, 35043
- Universitätsklinik Marburg,Hals-, Nasen- und Ohrenklinik, Sektion Rhinologie und Allergologie
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Weisbaden, 독일, 65183
- Zentrum für Rhinologie und Allergologie
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California
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Huntington Beach, California, 미국, 92648
- Allergy and Asthma Specialists Medical Group
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Inglewood, California, 미국, 90301
- 310 Clinical Research
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Laguna Niguel, California, 미국, 92677
- Allergy & Asthma Associates of Southern California dba. Southern California Research
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San Diego, California, 미국, 92123
- Allergy and Asthma
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Colorado
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Colorado Springs, Colorado, 미국, 80907-6231
- Asthma and Allergy Associates, PC
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Florida
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Tallahassee, Florida, 미국, 32308
- Allergy and Asthma Diagnostic Center
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Tampa, Florida, 미국, 33613
- University of South Florida
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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern University
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River Forest, Illinois, 미국, 60305
- Asthma Allergy Center of Chicago
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Kentucky
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Lexington, Kentucky, 미국, 40509
- Bluegrass Allergy Research
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Michigan
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Ypsilanti, Michigan, 미국, 48197
- Respiratory Medicine Research Institute of Michigan, PLC
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Minnesota
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Minneapolis, Minnesota, 미국, 55402
- Clinical Research Institute
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Missouri
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Columbia, Missouri, 미국, 65212
- University of Missouri Hospital
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St Louis, Missouri, 미국, 63141
- Allergy and Asthma Consultants
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Nebraska
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Bellevue, Nebraska, 미국, 68123
- Asthma and Allergy Center
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New Jersey
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Belleville, New Jersey, 미국, 07109
- Circuit Clinical/Hudson-Essex Allergy
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Hamilton, New Jersey, 미국, 08619
- Circuit Clinical/Mercer Allergy and Pulmonary Associates
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Teaneck, New Jersey, 미국, 07666
- Dr. Patrick Perin
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New York
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Horseheads, New York, 미국, 14845
- Smith Allergy and Asthma
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North Carolina
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Asheville, North Carolina, 미국, 28803
- Allergy Partners
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Ohio
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Cincinnati, Ohio, 미국, 45236
- Bernstein Clinical Research Center, LLC
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Oregon
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Portland, Oregon, 미국, 97202
- Northwest Research Center
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15241
- Allergy and Clinical Immunology Associates
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Texas
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Dallas, Texas, 미국, 75231
- AARA Research Center
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Kerrville, Texas, 미국, 78028
- Kerrville Allergy and Asthma Associates
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Wisconsin
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Greenfield, Wisconsin, 미국, 53228
- Allergy, Asthma & Sinus Center
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Brussels, 벨기에, 1070
- Hôpital Erasme, Service Pharmacie
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Erpent, 벨기에, 5101
- Pneumocare
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Ghent, 벨기에, 9000
- UZ Gent
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Leuven, 벨기에, 3000
- UZ Leuven, Pharmacy
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Liège, 벨기에, 4000
- Hôpital de la Citadelle
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Beijing, 중국, 100032
- Internal Medicine Building
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Beijing, 중국, 100730
- Department of Nasal Allergy
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Changsha, 중국, 410013
- The Third Xiangya Hospital of Central South University
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Guangzhou, 중국, 510000
- GCP Pharmacy
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Hangzhou, 중국, 310014
- Zhejiang People's Hospital
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Jingzhou, 중국, 434020
- Jingzhou Central Hospital
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Nanchang, 중국, 330006
- The First Affiliated Hospital of Nanchang University
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Nanchang, 중국, 330006
- The Second Affiliated Hospital of Nanchang University
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Nanning, 중국, 530021
- People's Hospital of Guangxi Zhuang Autonomous Region
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Nanning, 중국, 530021
- The First Affiliated Hospital of Guangxi Medical University
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Shanghai, 중국, 200065
- Tongji Hospital
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Wuhan, 중국, 430060
- Renmin Hospital of Wuhan University
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Wuhan, 중국, 430014
- Outpatient building
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Wuhan, 중국, 430022
- Outpatient Department, Union Hospital
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Yangzhou, 중국, 225001
- Northern Jiangsu People's Hospital
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Yangzhou, 중국, 225012
- Yangzhou University
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Zhongshan, 중국, 528403
- Zhongshan City People's Hospital
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Kielce, 폴란드, 25-355
- Polimedica PTG Kielce
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Krakow, 폴란드, 31-513
- Centrum Medyczne Promed ul. Olszańska 5G
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Krakow, 폴란드, 31-623
- Malopolskie Centrum Alergologii
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Lodz, 폴란드, 90-302
- gab. 114, ul. inż. pilota Wigury
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Lublin, 폴란드, 20-412
- ETG Lublin
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Piła, 폴란드, 64-920
- Centrum Alergologii Teresa Hofman Sp z.o.o.
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Rzeszów, 폴란드, 35-205
- EMED Centrum Usług Medycznych
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Skierniewice, 폴란드, 96-100
- ClinMedica Research
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Tarnów, 폴란드, 33-100
- Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
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Warsaw, 폴란드, 02-793
- ETG Warszawa
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Wroclaw, 폴란드, 53-201
- ALL-MED - Specjalistyczna Opieka Medyczna
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Physician-diagnosed perennial allergic rhinitis (PAR).
- Has a positive skin prick test (SPT) with indoor allergens and/or positive serum antigen-specific immunoglobulin E (IgE) for indoor allergens ≥0.70 kU/L, utilizing a validated assay (central laboratory).
- The participant must have clinical symptoms at study entry associated with positive perennial allergen as tested by the SPT or a positive serum antigen-specific IgE test.
- A participant who has a known history of dermatographism or identified during the SPT may participate in this study with a positive serum antigen-specific IgE test.
- Participants who have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.
Exclusion Criteria:
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Have received a dose of lebrikizumab.
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Is currently on AIT subcutaneous immunotherapy or sublingual immunotherapy. However, individuals who discontinued subcutaneous or sublingual immunotherapy for ≥3 years prior to randomization are eligible.
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Have received treatment with any rescue medication during the run-in period.
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Have received treatment with any biologic or systemic immunosuppressants, including Janus Kinase inhibitors (JAK) for inflammatory disease or autoimmune disease prior to the baseline visit:
- Any current or prior use of biologics indicated for asthma or AD are prohibited.
- B cell-depleting biologics, including rituximab, within 6 months.
- Other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
- Systemic immunosuppressants, including JAK inhibitors, within 4 weeks prior to baseline.
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Have a history of seasonal worsening of AR and if the seasonal worsening is expected during the 4-week run-in period, the first 16 weeks after randomization, or during the last 8 weeks of the maintenance period.
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Anticipates significant changes in their daily environmental exposure.
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Has a known history of recurrent acute or chronic sinusitis.
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Female participant who is pregnant, breastfeeding or is planning to become pregnant or to breastfeed during the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)
Lebrikizumab will be given as a subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS). |
Administered SC Administered as intranasal spray |
|
실험적: Lebrikizumab Q2W/every 8 weeks (Q8W)
Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS. |
Administered SC Administered as intranasal spray |
|
위약 비교기: Placebo Q2W/Q4W
Placebo matching Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS. |
Administered SC Administered as intranasal spray |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16
기간: Baseline, Week 16
|
Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were. |
Baseline, Week 16
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] Activities Domain at Week 16
기간: Baseline, Week 16
|
The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment). |
Baseline, Week 16
|
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Mean CFBL in RQLQ(S) Activities Domain at Week 56
기간: Baseline, Week 56
|
The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment) |
Baseline, Week 56
|
|
Mean CFBL in RQLQ(S) Total Score at Week 16
기간: Baseline, Week 16
|
The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment). |
Baseline, Week 16
|
|
Mean CFBL in RQLQ(S) Total Score at Week 56
기간: Baseline, Week 56
|
The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment). |
Baseline, Week 56
|
|
Mean CFBL in TNSS at Week 4
기간: Baseline, Week 4
|
Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were. |
Baseline, Week 4
|
|
Mean CFBL in TNSS at Week 56
기간: Baseline, Week 56
|
Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were. |
Baseline, Week 56
|
|
Mean CFBL in Postnasal Drip Score at Week 16
기간: Baseline, Week 16
|
Postnasal drip is mucus drainage down the throat, as part of their Allergic Rhinitis (AR), will be rated by participants using a 4-point scale, where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of their postnasal drip, at its worst, for the previous 24 hours. |
Baseline, Week 16
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 18789
- J2T-MC-KGBT (기타 식별자: Eli Lilly and Company)
- 2023-508817-18-00 (기타 식별자: EU Clinical Trial Number)
- 2023 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD 공유 기간
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD 공유 액세스 기준
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .