이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

수혈 의존성 알파- 또는 베타-지중해빈혈(α- 또는 β-TDT) 환자를 대상으로 Mitapivat의 효능 및 안전성을 평가하는 연구 (ENERGIZE-T)

2026년 10월 27일 업데이트: Agios Pharmaceuticals, Inc.

수혈 의존성 알파 또는 베타 지중해빈혈(ENERGIZE-T) 대상자에서 Mitapivat의 효능 및 안전성을 평가하는 3상, 이중 맹검, 무작위, 위약 대조, 다기관 연구

The primary objective of this study was to compare the effect of mitapivat versus placebo on transfusion burden in participants with α- or β-transfusion-dependent thalassemia.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

The mitapivat group included 171 participants. The placebo group included 87 participants.

연구 유형

중재적

등록 (실제)

258

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 그리스
      • Achaia, 그리스, 26504
        • University General Hospital of Patras
      • Athens, 그리스, 11527
        • Children's Hospital Agia Sophia, National and Kapodistrian University of Athens Medical School
      • Athens, 그리스, 115 26
        • Laiko General Hospital
      • Ioannina, 그리스, 455 00
        • University Hospital of Ioannina
      • Thessaloniki, 그리스, 546 42
        • Ippokrateio General Hospital
  • 네덜란드
      • Amsterdam, 네덜란드, 1105 AZ
        • Amsterdam Universitair Medisch Centrum, Locatie AMC
      • Utrecht, 네덜란드, 3584 CX
        • Universitair Medisch Centrum Utrecht
      • Westzeedijk 353, 네덜란드, 3015 AA
        • Erasmus MC
  • 대만
      • Taipei, 대만, 100
        • National Taiwan University Hospital
  • 덴마크
      • Hovedstaden, 덴마크, 2100
        • Rigshospitalet
  • 독일
      • Berlin, 독일, 13353
        • Charité - UB - CVK - Medizinische Klinik
      • Essen, 독일, 45122
        • Universitätsklinikum Essen
      • Leipzig, 독일, 04103
        • Universitätsklinikum Leipzig
  • 레바논
      • Beirut, 레바논, 9999
        • Chronic Care Center
  • 말레이시아
      • Alor Star, 말레이시아, 05460
        • Hospital Sultanah Bahiyah
      • Johor Bahru, 말레이시아, 80100
        • Hospital Sultanah Aminah Johor Bahru
      • Kota Kinabalu, 말레이시아, 88586
        • Hospital Queen Elizabeth, Kota Kinabalu
      • Kuala Lumpur, 말레이시아, 50300
        • Hospital Tunku Azizah
      • Kuantan, 말레이시아, 25100
        • Hospital Tengku Ampuan Afzan
      • Kuching, 말레이시아, 93586
        • Hospital Umum Sarawak
      • Pandan Indah, 말레이시아, 68000
        • Hospital Ampang
      • Pulau Pinang, 말레이시아, 10990
        • Hospital Pulau Pinang
  • 미국
    • Arizona
      • Phoenix, Arizona, 미국, 85016-7710
        • Phoenix Children's Hospital
    • California
      • La Jolla, California, 미국, 92093
        • San Diego Hospital, UC San Diego Health
      • Oakland, California, 미국, 94609-1809
        • Children's Hospital Oakland
      • Palo Alto, California, 미국, 94304-1601
        • Stanford Medicine
    • Massachusetts
      • Boston, Massachusetts, 미국, 02115
        • Boston Children's Hospital
    • Michigan
      • Detroit, Michigan, 미국, 48201-2196
        • Children's Hospital of Michigan
    • New York
      • New York, New York, 미국, 10065-4870
        • Weill Cornell Medical Center
    • North Carolina
      • Durham, North Carolina, 미국, 27710-3038
        • Duke University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19104
        • Penn Medicine - University of Pennsylvania Health System
    • Washington
      • Seattle, Washington, 미국, 98101
        • Seattle Cancer Care Alliance, University of Washington
  • 불가리아
      • Kyustendil, 불가리아, 2500
        • MHAT "Dr. Nikola Vasiliev" AD
      • Pleven, 불가리아, 5800
        • UMHAT "Dr. Georgi Stranski" Pleven
      • Plovdiv, 불가리아, 4002
        • UMHAT "Sveti Georgi" EAD
      • Sofia, 불가리아, 1756
        • SHATHD Sofia
      • Stara Zagora, 불가리아, 6000
        • UMHAT "Prof. Dr. Stoyan Kirkovich"
  • 브라질
      • Ribeirão Preto, 브라질, 14051-260
        • Hospital Das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
      • São Paulo, 브라질, 04006-002
        • GSH Banco de Sangue de São Paulo
  • 사우디 아라비아
      • Riyadh, 사우디 아라비아, 14611
        • King Abdullah International Medical Research Center
      • Riyadh, 사우디 아라비아, 90210
        • King Khalid University Hospital
  • 스페인
      • Barcelona, 스페인, 08035
        • Hospital Universitario Vall d'Hebron
      • Madrid, 스페인, 28046
        • Hospital Universitario La Paz
      • Murcia, 스페인, 30120
        • Hospital Universitario Virgen Arrixaca
      • Seville, 스페인, 41013
        • Hospital Universitario Virgen del Rocío
  • 아랍 에미리트
      • Abu Dhabi, 아랍 에미리트
        • Burjeel Medical City
  • 영국
      • London, 영국, WC1E 6BT
        • University College London
      • London, 영국, W12 0HS
        • Imperial College Healthcare NHS Trust - Hammersmith Hospital
  • 이탈리아
      • Brindisi, 이탈리아, 72100
        • Ospedale "A. Perrino" - Brindisi
      • Cagliari, 이탈리아, 09121
        • Ospedale Pediatrico Microcitemico
      • Ferrara, 이탈리아, 44124
        • Ospedale Sant'Anna
      • Genova, 이탈리아, 16128
        • Ente Ospedaliero Ospedali Galliera
      • Milan, 이탈리아, 20122
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
      • Modena, 이탈리아, 41124
        • A.O.U Di Modena
      • Naples, 이탈리아, 80138
        • AOU L. Vanvitelli Universita degli Studi della Campania Luigi Vanvitelli
      • Orbassano, 이탈리아, 10043
        • A.O.U. San Luigi Gonzaga
  • 캐나다
    • Alberta
      • Calgary, Alberta, 캐나다, T2N 2T9
        • Foothills Medical Centre
    • Ontario
      • Toronto, Ontario, 캐나다, M5G 2C4
        • Toronto General Hospital, University Health Network
  • 태국
      • Bangkok, 태국, 10400
        • Phramongkutklao Hospital
      • Bangkok, 태국, 10400
        • Ramathibodi Hospital
      • Bangkok, 태국, 10700
        • Faculty of Medicine Siriraj Hospital
      • Chiang Mai, 태국, 50200
        • Maharaj Nakorn Chiang Mai Hospital
      • Khon Kaen, 태국, 40000
        • Srinagarind Hospital, Khon Kaen University
      • Mueang Phitsanulok, 태국, 65000
        • Naresuan University Hospital
      • Pathum Wan, 태국
        • King Chulalongkorn Memorial Hospital
  • 터키 (Türkiye)
      • Adana, 터키 (Türkiye), 1130
        • Acibadem Adana Hospital
      • Antalya, 터키 (Türkiye), 07059
        • Akdeniz University Faculty of Medicine
      • Balcalı, 터키 (Türkiye), 01330
        • Çukurova University
      • Bornova, 터키 (Türkiye), 35040
        • Ege University Faculty of Medicine
      • Fatih, 터키 (Türkiye), 34093
        • Istanbul University Faculty of Medicine
      • Mersin, 터키 (Türkiye)
        • Hacettepe University
  • 프랑스
      • Créteil, 프랑스, 94010
        • CHU Hôpital Henri Mondor
      • Lyon, 프랑스, 69003
        • Hôpital Edouard Herriot, CHU de Lyon
      • Marseille, 프랑스, 13385
        • CHU Hôpital de la Timone
      • Paris, 프랑스, 75015
        • Hôpital Necker Enfants Malades

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Greater than or equal to (≥)18 years of age at the time of providing informed consent;
  • Documented diagnosis of thalassemia (β-thalassemia with or without α-globin gene mutations, hemoglobin E (HbE)/β-thalassemia, or α-thalassemia/hemoglobin H (HbH) disease) based on deoxyribonucleic acid (DNA) analysis;
  • Considered transfusion-dependent, defined as 6 to 20 red blood cells (RBC) units transfused and ≤6-week transfusion-free period during the 24-week period before randomization;
  • If taking hydroxyurea, the hydroxyurea dose must be stable for ≥16 weeks before randomization;
  • Women of childbearing potential (WOCBP) must be abstinent of sexual activities that may induce pregnancy as part of their usual lifestyle or agree to use two forms of contraception, one of which must be considered highly effective, from the time of providing informed consent, throughout the study, and for 28 days after the last dose of study drug. The second form of contraception can be an acceptable barrier method;
  • Written informed consent before any study-related procedures are conducted and willing to comply with all study procedures for the duration of the study.

Exclusion Criteria:

  • Pregnant, breastfeeding, or parturient;

  • Documented history of homozygous or heterozygous sickle hemoglobin (Hb S) or hemoglobin C (Hb C);

  • Prior exposure to gene therapy or prior bone marrow or stem cell transplantation;

  • Currently receiving treatment with luspatercept; the last dose must have been administered ≥36 weeks before randomization;

  • Currently receiving treatment with hematopoietic stimulating agents; the last dose must have been administered ≥36 weeks before randomization;

  • History of malignancy (active or treated) ≤5 years before providing informed consent, except for nonmelanomatous skin cancer in situ, cervical carcinoma in situ, or breast carcinoma in situ;

  • History of active and/or uncontrolled cardiac or pulmonary disease ≤6 months before providing informed consent;

  • Hepatobiliary disorders;

  • Estimated glomerular filtration rate <45 milliliters per minute (mL/min)/1.73 meter (m)^2 by Chronic Kidney Disease Epidemiology Collaboration creatinine equation;

  • Nonfasting triglycerides >440 milligrams per deciliter (mg/dL) (5 millimoles per liter [mmol/L]);

  • Active infection requiring systemic antimicrobial therapy at the time of providing informed consent;

  • Positive test for hepatitis C virus antibody (HCVAb) with evidence of active HCV infection, or positive test for hepatitis B surface antigen (HBsAg);

  • Positive test for human immunodeficiency virus (HIV)-1 antibody (Ab) or HIV-2 Ab;

  • History of major surgery (including splenectomy) ≤6 months before providing informed consent and/or a major surgical procedure planned during the study;

  • Current enrollment or past participation (≤12 weeks before administration of the first dose of study drug or a timeframe equivalent to 5 half-lives of the investigational study drug, whichever is longer) in any other clinical study involving an investigational treatment or device;

  • Receiving strong CYP3A4/5 inhibitors that have not been stopped for ≥5 days or a timeframe equivalent to 5 half-lives (whichever is longer); or strong CYP3A4 inducers that have not been stopped for ≥4 weeks or a timeframe equivalent to 5 half-lives (whichever is longer), before randomization;

  • Receiving anabolic steroids that have not been stopped for at least 4 weeks before randomization. Testosterone replacement therapy to treat hypogonadism is allowed. The testosterone dose and preparation must be stable for ≥12 weeks before randomization;

  • Known allergy, or other contraindication, to mitapivat or its excipients (microcrystalline cellulose, croscarmellose sodium, sodium stearyl fumarate, mannitol, and magnesium stearate, Opadry® II Blue [hypromellose, titanium dioxide, lactose monohydrate, triacetin, and Federal Food, Drug, and Cosmetic (FD&C) Blue #2]);

  • Any medical, hematological, psychological, or behavioral condition(s) or prior or current therapy that, in the opinion of the Investigator, may confer an unacceptable risk to participating in the study and/or could confound the interpretation of the study data. Also excluded are:

    • Participants who are institutionalized by regulatory or court order
    • Participants with any condition(s) that could create undue influence (including but not limited to incarceration, involuntary psychiatric confinement, and financial or familial affiliation with the Investigator or Sponsor).

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: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Mitapivat

Participants randomized to receive mitapivat 100 milligrams (mg), orally, twice daily (BID) for 48 weeks in the double-blind (DB) period and for up to 5 years in the open label extension (OLE) period.
의약품: Mitapivat

Tablets

다른 이름들:
  • AG-348
  • AG-348 황산염 수화물
  • 미타피밧 설페이트
위약 비교기: Placebo

Participants randomized to receive placebo matching mitapivat, orally, BID for 48 weeks in the DB period followed by mitapivat 100 mg, orally, BID for up to 5 years in the OLE period.
의약품: Mitapivat

Tablets

다른 이름들:
  • AG-348
  • AG-348 황산염 수화물
  • 미타피밧 설페이트
의약품: Placebo Matching Mitapivat

Tablets

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Double-blind Period: Percentage of Participants Who Achieved Transfusion Reduction Response (TRR)
기간: Double-blind Period: Baseline through Week 48

TRR is defined as ≥50% reduction in transfused red blood cells (RBC) units with a reduction of ≥2 units of transfused RBCs in any consecutive 12-week period through Week 48 compared with baseline transfusion burden standardized to 12 weeks. Baseline transfusion burden standardized to 12 weeks= (12/24) × total number of RBC units transfused during 24-week period before the randomization date for participants randomized and not dosed or the start of study treatment for participants randomized and dosed. Participants withdrawn from the study before Week 12 (Day 85) were considered nonresponders.
Double-blind Period: Baseline through Week 48

2차 결과 측정

결과 측정
측정값 설명
기간
이중 맹검 기간 : Mitapivat의 혈장 농도
기간: 이중 맹검 기간 : 12 주차의 사전 복용; 24 주차에 사전 복용; 사전 복용량, 0.5, 1, 3, 5, 7 시간 36 주에 복용 후 7 시간
이중 맹검 기간 : 12 주차의 사전 복용; 24 주차에 사전 복용; 사전 복용량, 0.5, 1, 3, 5, 7 시간 36 주에 복용 후 7 시간
이중 맹검 기간 : Mitapivat의 최대 관찰 된 혈장 농도 (CMAX)
기간: 이중 맹검 기간 : 사전 복용량, 0.5, 1, 3, 5, 7 시간 복용 후 36
이중 맹검 기간 : 사전 복용량, 0.5, 1, 3, 5, 7 시간 복용 후 36
이중 맹검 기간 : Mitapivat의 최대 관찰 된 혈장 농도 (Tmax)에 도달하는 시간
기간: 이중 맹검 기간 : 사전 복용량, 0.5, 1, 3, 5, 7 시간 복용 후 36
이중 맹검 기간 : 사전 복용량, 0.5, 1, 3, 5, 7 시간 복용 후 36
이중 맹검 기간 : Mitapivat의 마지막 정량화 가능한 농도 (tlast)의 시간
기간: 이중 맹검 기간 : 사전 복용량, 0.5, 1, 3, 5, 7 시간 복용 후 36
이중 맹검 기간 : 사전 복용량, 0.5, 1, 3, 5, 7 시간 복용 후 36
이중 맹검 기간 : 아데노신 트리 포스페이트의 혈액 농도 (ATP)
기간: 이중 맹검 기간 : 1 일의 사전 복용; 12 주차에 사전 복용; 24 주차에 사전 복용; 사전 복용량, 0.5, 1, 3, 5, 7 시간 36 주에 복용 후 7 시간
이중 맹검 기간 : 1 일의 사전 복용; 12 주차에 사전 복용; 24 주차에 사전 복용; 사전 복용량, 0.5, 1, 3, 5, 7 시간 36 주에 복용 후 7 시간
이중 맹검 기간 : 혈액 농도 2,3-Diphosphoglycerate (2,3-DPG)
기간: 이중 맹검 기간 : 1 일의 사전 복용; 12 주차에 사전 복용; 24 주차에 사전 복용; 사전 복용량, 0.5, 1, 3, 5, 7 시간 36 주에 복용 후 7 시간
이중 맹검 기간 : 1 일의 사전 복용; 12 주차에 사전 복용; 24 주차에 사전 복용; 사전 복용량, 0.5, 1, 3, 5, 7 시간 36 주에 복용 후 7 시간
Double-blind Period: Percentage of Participants Who Achieved TRR2
기간: Double-blind period: Baseline through Week 48

TRR2, defined as a ≥50% reduction in transfused RBC units in any consecutive 24-week period through Week 48 compared with the 24-week baseline transfusion burden, is reported. Baseline transfusion burden standardized to 24 weeks is the total number of RBC units transfused during the 24-week period before the randomization date for participants randomized and not dosed or the start of study treatment for participants randomized and dosed. Participants withdrawn from the study before Week 24 (Day 169) were considered nonresponders.
Double-blind period: Baseline through Week 48
Double-blind Period: Percentage of Participants Who Achieved TRR3
기간: Double-blind period: Baseline up to Week 13 through Week 48

TRR3, defined as a ≥33% reduction in transfused RBC units from Week 13 through Week 48 compared with the baseline transfusion burden standardized to 36 weeks, is reported. Baseline transfusion burden standardized to 36 weeks= (36/24) × total number of RBC units transfused during the 24-week period before the randomization date for participants randomized and not dosed or the start of study treatment for participants randomized and dosed. Participants withdrawn from the study before Week 48 were considered nonresponders.
Double-blind period: Baseline up to Week 13 through Week 48
Double-blind Period: Percentage of Participants Who Achieved TRR4
기간: Double-blind period: Baseline up to Week 13 through Week 48

TRR4, defined as a ≥50% reduction in transfused RBC units from Week 13 through Week 48 compared with the baseline transfusion burden standardized to 36 weeks, is reported. Baseline transfusion burden standardized to 36 weeks = (36/24) × total number of RBC units transfused during the 24-week period before the randomization date for participants randomized and not dosed or the start of study treatment for participants randomized and dosed. Participants withdrawn from the study before Week 48 were considered nonresponders.
Double-blind period: Baseline up to Week 13 through Week 48
Double-blind Period: Percent Change From Baseline in Transfused RBC Units
기간: Double-blind Period: Baseline, Week 13 through Week 48

Transfusion burden from Week 13 through Week 48 standardized to 36 weeks is defined as number of transfused RBC units from Day 85 through Week 48 in the Double-blind Period ×36/(Number of days from Day 85 through Week 48 in the Double-blind Period/7). Baseline transfusion burden standardized to 36 weeks= (36/24)× is the total number of RBC units transfused during the 24-week period before the randomization date for participants randomized and not dosed or within 168 days before the start of study treatment for participants randomized and dosed.
Double-blind Period: Baseline, Week 13 through Week 48
Double-blind Period: Percentage of Participants Who Achieved Transfusion-Independence
기간: Double-blind Period: Baseline through Week 48

Transfusion-independence is defined as transfusion-free for ≥8 consecutive weeks through Week 48 in the double-blind period.
Double-blind Period: Baseline through Week 48
Double-blind Period: Change From Baseline in Iron Levels
기간: Double-blind Period: Baseline through Week 48

Iron metabolism was assessed based on Iron levels.
Double-blind Period: Baseline through Week 48
Double-blind Period: Change From Baseline in Serum Ferritin Levels
기간: Double-blind Period: Baseline through Week 48

Iron metabolism was assessed based on serum ferritin levels.
Double-blind Period: Baseline through Week 48
Double-blind Period: Change From Baseline in Total Iron Binding Capacity
기간: Double-blind Period: Baseline through Week 48

Iron metabolism was assessed based on total iron binding capacity.
Double-blind Period: Baseline through Week 48
Double-blind Period: Change From Baseline in Transferrin Saturation (TSAT) Levels
기간: Double-blind Period: Baseline through Week 48

Iron metabolism was assessed based on TSAT levels. Transferrin saturation is reported by dividing value of serum iron by total iron binding capacity.
Double-blind Period: Baseline through Week 48
Double-blind Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs With Severity Greater Than or Equal to Grade 3
기간: Double-blind Period: From first dose of study drug up to week 48

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug. A serious adverse event (SAE) is any untoward medical occurrence that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are AEs with an initial onset date during the on-treatment period or worsening from baseline and includes both serious & non-serious TEAEs. Severity of AEs was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; Version 4.03): grade 1: mild; grade 2: moderate; grade 3: severe or medically significant but not immediately life-threatening; grade 4: life threatening or disabling; grade 5: death related to AE.
Double-blind Period: From first dose of study drug up to week 48
Open-label Extension Period: Number of Participants With TEAEs, Serious TEAEs, Related TEAEs, Related TEAEs and TEAEs With Severity of Greater Than or Equal to 3
기간: Open-Label Extension Period: From Week 48 up to end of study (approximately 5 years)

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug. A serious adverse event (SAE) is any untoward medical occurrence that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are AEs with an initial onset date during the on-treatment period or worsening from baseline and includes both serious & non-serious TEAEs. Severity of abnormalities was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; Version 4.03): grade 1: mild; grade 2: moderate; grade 3: severe or medically significant but not immediately life-threatening; grade 4: life threatening or disabling; grade 5: death related to AE.
Open-Label Extension Period: From Week 48 up to end of study (approximately 5 years)
Double-blind Period: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of Mitapivat
기간: Double-blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 36

Area under the concentration-time curve from time zero to Tlast on dosing day, calculated using the linear-log trapezoidal rule.
Double-blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 36
Double-blind Period: Last Quantifiable Plasma Concentration (Clast) of Mitapivat
기간: Double-blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose Week 36

Clast is the last quantifiable concentration after a single dose or within the dosing interval (tau) for multiple doses.
Double-blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose Week 36

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Agios Pharmaceuticals, Inc.

수사관

  • 연구 의자: Medical Affairs, Agios Pharmaceuticals, Inc.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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)

2021년 11월 30일

기본 완료 (실제)

2024년 4월 11일

연구 완료 (추정된)

2029년 6월 1일

연구 등록 날짜

최초 제출

2021년 2월 18일

QC 기준을 충족하는 최초 제출

2021년 2월 22일

처음 게시됨 (실제)

2021년 2월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 27일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • AG348-C-018
  • 2021-000212-34 (EudraCT 번호)
  • 2024-512747-23-00 (씨티스)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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. .

구독하다