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임상시험 NCT06128629은(는) 심근병증을 동반한 트랜스티레틴 아밀로이드증 (ATTR)에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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인텔리아 테라퓨틱스MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM) 3상 1,200 단일 투여
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06128629은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 심근병증을 동반한 트랜스티레틴 아밀로이드증 (ATTR)에 대해 진행되며, 3상 중재연구으로 현재 상태는 모집중입니다. 연구는 2023년 12월 13일에 시작되어 1,200명의 참여자를 모집하고 있습니다. 인텔리아 테라퓨틱스이(가) 진행하며, 2028년 4월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 27일에 갱신되었습니다.
간단한 개요
To evaluate the efficacy and safety of a single dose of NTLA-2001 compared to placebo in participants with ATTR-CM.
상세한 설명
This is a multinational, multicenter, double-blind, placebo-controlled study in approximately 1200 participants, who will be randomized to receive a single infusion of either NTLA-2001 or placebo.
공식 제목
MAGNITUDE: A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
질환명
심근병증을 동반한 트랜스티레틴 아밀로이드증 (ATTR)기타 연구 식별자
- ITL-2001-CL-301
NCT 번호
실제 연구 시작일
2023-12-13
최신 업데이트 게시
2026-03-27
예상 연구 완료일
2028-04
계획된 등록 인원
1,200
연구종류
중재연구
단계/상
3상
상태
모집중
키워드
TTR
Amyloidosis
Cardiomyopathy
NTLA-2001
ATTR-CM
Transthyretin
ATTR
TTR-mediated amyloidosis
Amyloidosis, Hereditary
Amyloidosis, Hereditary, Transthyretin-Related Amyloidosis
Transthyretin amyloid cardiomyopathy
TTR cardiomyopathy
Wild-type TTR
V122I
Amyloidosis, Wild Type
CRISPR/Cas9
Amyloidosis
Cardiomyopathy
NTLA-2001
ATTR-CM
Transthyretin
ATTR
TTR-mediated amyloidosis
Amyloidosis, Hereditary
Amyloidosis, Hereditary, Transthyretin-Related Amyloidosis
Transthyretin amyloid cardiomyopathy
TTR cardiomyopathy
Wild-type TTR
V122I
Amyloidosis, Wild Type
CRISPR/Cas9
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
사중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적NTLA-2001 Single intravenous (IV) infusion of NTLA-2001 | NTLA-2001 NTLA-2001 (55mg) by IV infusion |
위약 대조군Placebo Single IV infusion of normal saline | 위약 Normal saline (0.9% NaCl) by IV infusion |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Composite outcome of cardiovascular (CV) mortality and CV events | Maximum study duration is dependent on event rates and is estimated to be at least 18 months and up to approximately 5 years |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Change in baseline to month 18 in serum TTR | Baseline, Month 18 | |
Change from baseline to month 18 in KCCQ-OS score | Baseline, Month 18 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Documented diagnosis of ATTR amyloidosis with cardiomyopathy
- Medical history of heart failure (HF)
- Symptoms of HF are optimally managed and clinically stable within 28 days prior to administration of study intervention
- Screening NT-proBNP, a blood marker of HF severity, greater than or equal to 600 pg/mL and less than 10,000 pg/mL
- New York Heart Association (NYHA) Class IV HF
- Polyneuropathy Disability score of IV (confined to wheelchair or bed)
- Has hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
- History of active malignancy within 3 years prior to screening
- RNA silencer therapy (patisiran, inotersen and/or eplontersen) within 12 months prior to dosing. Any prior vutrisiran use is not allowed
- Initiation of tafamidis or acoramidis within 56 days prior to study dosing
- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m^2
- History of liver disease
- Uncontrolled blood pressure
- Unable or unwilling to take vitamin A supplementation for the duration of the study
인텔리아 테라퓨틱스7개의 진행 중인 임상시험 탐색 가능리제네론 파마슈티컬스214개의 진행 중인 임상시험 탐색 가능연구 대표 연락처
연락처: Trial Manager at Intellia, 1-857-285-6200, [email protected]
132 26개국에 임상시험 장소
Chonnam National University Hospital, Gwangju, South Korea
철회
Samsung Medical Center, Seoul, South Korea
철회
Seoul National University Hospital, Seoul, South Korea
철회
Severance Hospital, Yonsei University Health System, Seoul, South Korea
철회
Arizona
University of Arizona, Tucson, Arizona, 85724, United States
모집중
California
Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States
모집중
Western Greater Los Angeles VA Medical Center, Los Angeles, California, 90073, United States
모집중
Stanford University, Palo Alto, California, 94305, United States
모집중
University of California, San Diego (UCSD) - Medical Center, San Diego, California, 92103, United States
모집중
Colorado
University of Colorado Denver, Denver, Colorado, 80045, United States
모집중
Connecticut
Yale University School of Medicine, New Haven, Connecticut, 06510, United States
모집중
District of Columbia
MedStar Washington Hospital Center - MedStar Heart and Vascular Institute, Washington D.C., District of Columbia, 20010, United States
모집중
Florida
Mayo Clinic - Jacksonville, Jacksonville, Florida, 32224, United States
모집중
Cleveland Clinic of Florida, Weston, Florida, 33331, United States
모집중
Georgia
Emory University School of Medicine, Atlanta, Georgia, 30322, United States
모집중
Illinois
Northwestern University, Chicago, Illinois, 60611, United States
모집중
Indiana
Indiana University Health, Indianapolis, Indiana, 46202, United States
모집중
Kentucky
University of Kentucky Gill Heart Institute, Lexington, Kentucky, 40536, United States
모집중
Maryland
Johns Hopkins University, Baltimore, Maryland, 21287, United States
모집중
Massachusetts
Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States
모집중
Boston University School of Medicine, Boston, Massachusetts, 02118, United States
모집중
Michigan
University of Michigan, Ann Arbor, Michigan, 48109, United States
모집중
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201, United States
철회
Minnesota
Mayo Clinic, Rochester, Minnesota, 55905, United States
모집중
Missouri
St. Luke's Hospital, Kansas City, Missouri, 64111, United States
모집중
New York
New York University (NYU) School of Medicine - Langone Medical Center, New York, New York, 10016, United States
모집중
Columbia University Medical Center, New York, New York, 10032, United States
모집중
North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States
모집중
Ohio
Cleveland Clinic, Cleveland, Ohio, 44195, United States
모집중
Ohio Health Research Institute, Columbus, Ohio, 43214, United States
모집중
Oregon
Oregon Health and Science University (OHSU), Portland, Oregon, 97239, United States
모집중
Pennsylvania
Penn Presbyterian Medical Center, Philadelphia, Pennsylvania, 19104, United States
모집중
Allegheny General Hospital, Pittsburgh, Pennsylvania, 15212, United States
모집중
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15219, United States
모집중
South Carolina
Medical University of South Carolina, Charleston, South Carolina, 29425, United States
모집중
Texas
Baylor Scott & White Research Institute, Dallas, Texas, 75201, United States
모집중
University of Texas Southwestern Medical Center, Dallas, Texas, 75390, United States
모집중
Baylor College of Medicine, Houston, Texas, 77030, United States
모집중
Houston Methodist Hospital, Houston, Texas, 77030, United States
모집중
Baylor Scott and White - The Heart Hospital Baylor Plano, Plano, Texas, 75093, United States
모집중
Virginia
INOVA Fairfax Hospital, Falls Church, Virginia, 22042, United States
모집중
Virginia Commonwealth University - Department of Internal Medicine, Richmond, Virginia, 23298, United States
모집중
Fundacion Favalro, Buenos Aires, Argentina
모집중
Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
모집중
ICBA, Buenos Aires, Argentina
모집중
Fundacion Favaloro, Ciudad Autonoma de Buenos Aire, Argentina
모집중
Hospital Italiano de Buenos Aires, Ciudad Autonoma de Buenos Aire, Argentina
모집중
Hospital Privado de Rosario, Rosario, Argentina
모집중
Australian Capital Territory
The Canberra Hospital, Garran, Australian Capital Territory, Australia
모집중
New South Wales
Westmead Hospital, Westmead, New South Wales, Australia
모집중
Queensland
Cairns Hospital, Cairns, Queensland, Australia
철회
Victoria
Eastern Health - Box Hill Hospital, Box Hill, Victoria, Australia
모집중
Western Australia
Fiona Stanley Hospital, Perth, Western Australia, Australia
모집중
Royal Adelaide Hospital, Adelaide, Australia
모집중
The Alfred Hospital, Melbourne, Australia
모집중
Princess Alexandra Hospital, Woolloongabba, Australia
모집중
Medizinische Universitaet Innsbruck, Innsbruck, Austria
모집중
Universitaesklinikum St. Poelten, Sankt Pölten, Austria
모집중
AZ Sint-Jan Brugge, Bruges, Belgium
모집중
Universite Libre de Bruxelles (ULB) - Hopital Erasme, Brussels, Belgium
모집중
Antwerp University Hospital, Edegem, Belgium
모집중
UZ Leuven, Leuven, Belgium
모집중
Centre Hospitalier Regional de la Citadelle, Liège, Belgium
모집중
Centro de Pesquisa NUPEC - Instituto Orizonti em Belo Horizonte, Belo Horizonte, Brazil
모집중
Complexo Hospitalar de Niterói (CHN-DASA), Niterói, Brazil
모집중
CAPED - Centro Avancado de Pesquisa, Ribeirão Preto, Brazil
모집중
HCFMRP - Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto, Ribeirão Preto, Brazil
모집중
Cardiopulmonar da Bahia S. A. (Hospital Cardio Pulmonar), Salvador, Brazil
모집중
Hospital Israelita Albert Einstein, São Paulo, Brazil
모집중
Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
모집중
Instituto do Coracao (InCor) do Hospital das Clinicas da FMUSP, São Paulo, Brazil
모집중
PSEG Centro de Pesquisa Clinica S.A., São Paulo, Brazil
모집중
Alberta
Alberta Health Services - University of Calgary, Calgary, Alberta, Canada
모집중
British Columbia
Vancouver Coastal Health Research Institute, Vancouver, British Columbia, Canada
모집중
Ontario
University Health Network - Toronto General Hospital, Toronto, Ontario, Canada
모집중
Quebec
McGill University Health Centre, Montreal, Quebec, Canada
모집중
Fakultni nemocnice u sv. Anny v Brne, Brno, Czechia
모집중
Aarhus University Hospital, Aarhus, Denmark
모집중
Rigshospitalet, Copenhagen, Denmark
모집중
AP-HP Hopital Henri Mondor, Créteil, France
모집중
AP-HM - Hopital de la Timone, Marseille, France
모집중
AP-HP Hopital Bichat - Claude Bernard, Paris, France
모집중
CHU Rennes - Hopital Pontchaillou, Rennes, France
모집중
CHU de Toulouse - Hopital Rangueil, Toulouse, France
모집중
Charite Universitaetsmedizin Berlin, Berlin, Germany
모집중
Universitaetsklinikum Essen, Essen, Germany
모집중
Universitaetsklinikum Heidelberg, Heidelberg, Germany
모집중
Universitaetsklinikum Wuerzburg, Würzburg, Germany
모집중
Semmelweis Egyetem Belgyogyaszati es Hematologiai Klinika, Budapest, Hungary
모집중
Rambam Health Care Campus, Haifa, Israel
모집중
Hadassah University Hospital, Ein Karem, Jerusalem, Israel
모집중
Sheba Medical Center, Tel Litwinsky, Israel
모집중
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola, Bologna, Italy
모집중
Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna, Cona, Italy
모집중
Azienda Ospedaliero-Universitaria Careggi, Florence, Italy
모집중
Ospedale Policlinico San Martino IRCCS, Genova, Italy
모집중
Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
모집중
Fondazione Toscana Gabriele Monasterio per la Ricerca Medica, Pisa, Italy
모집중
Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara, Trieste, Italy
모집중
Kumamoto University Hospital, Kumamoto, Japan
모집중
National Cerebral and Cardiovascular Center, Osaka, Japan
모집중
The University of Tokyo Hospital, Tokyo, Japan
모집중
Toyama University Hospital, Toyama, Japan
모집중
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico
모집중
University Medical Center, Groningen, Netherlands
모집중
Erasmus MC, Rotterdam, Netherlands
모집중
Universitair Medisch Centrum Utrecht, Utrecht, Netherlands
모집중
New Zealand Clinical Research, Auckland, New Zealand
모집중
New Zealand Clinical Research, Christchurch, New Zealand
모집중
Oslo University Hospital - Rikshospitalet, Oslo, Norway
모집중
Centro Hospitalar Universitario de Lisboa Norte, Lisbon, Portugal
모집중
Centro Hospitalar Universitario do Porto, Porto, Portugal
모집중
National Heart Centre, Singapore, Singapore
모집중
National University Hospital, Singapore, Singapore
모집중
Hospital Universitario de A Coruna, A Coruña, Spain
모집중
Hospital Universitari de Bellvitge, Barcelona, Spain
모집중
Hospital Universitario Vall d'Hebron, Barcelona, Spain
모집중
Hospital Universitario Puerta de Hierro, Majadahonda, Spain
모집중
Hospital Universitario Virgen de la Victoria, Málaga, Spain
모집중
Hospital Universitario Son Llatzer, Palma de Mallorca, Spain
모집중
Karolinska University Hospital, Stockholm, Sweden
모집중
University Hospital of Umea, Umeå, Sweden
모집중
Far Eastern Memorial Hospital, New Taipei City, Taiwan
모집중
National Taiwan University Hospital, Taipei, Taiwan
모집중
Taipai Veterans General Hospital, Taipei, Taiwan
모집중
Synexus Midlands Clinical Research Centre, Birmingham, United Kingdom
진행중, 모집종료
Synexus Wales Clinical Research Centre, Cardiff, United Kingdom
진행중, 모집종료
Synexus Scotland Clinical Research Centre, Glasgow, United Kingdom
진행중, 모집종료
Synexus Hexham Clinical Research Centre, Hexham, United Kingdom
진행중, 모집종료
Synexus Merseyside Clinical Research Centre, Liverpool, United Kingdom
진행중, 모집종료
Richmond Pharmacology, London, United Kingdom
모집중
Synexus Manchester Clinical Research Centre, Manchester, United Kingdom
진행중, 모집종료