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輸血依存性アルファまたはベータサラセミア（α-またはβ-TDT）の参加者におけるミタピバットの有効性と安全性を評価する研究 (ENERGIZE-T)

2026年10月27日 更新者：Agios Pharmaceuticals, Inc.

輸血依存性アルファサラセミアまたはベータサラセミア（ENERGIZE-T）の被験者におけるミタピバットの有効性と安全性を評価する第3相、二重盲検、無作為化、プラセボ対照、多施設試験

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.

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

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

研究の種類

介入

入学 (実際)

258

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：Mitapivat

Tablets

他の名前：
  • AG-348
  • AG-348硫酸塩水和物
  • 硫酸ミタピバット
プラセボコンパレーター：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.
薬：Mitapivat

Tablets

他の名前：
  • AG-348
  • AG-348硫酸塩水和物
  • 硫酸ミタピバット
薬：Placebo Matching Mitapivat

Tablets

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Double-blind Period: Percentage of Participants Who Achieved Transfusion Reduction Response (TRR)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
二重盲検期間：Mitapivatの血漿濃度
時間枠：二重盲検期間：12週目の事前投与。 24週目の事前投与。前投与、0.5、1、3、5、36週目の投与後7時間
二重盲検期間：12週目の事前投与。 24週目の事前投与。前投与、0.5、1、3、5、36週目の投与後7時間
二重盲検期間：Mitapivatの最大観測血漿濃度（CMAX）
時間枠：二重盲検期間：投与前、0.5、1、3、5、7時間投与後36
二重盲検期間：投与前、0.5、1、3、5、7時間投与後36
二重盲検期間：MITAPIVATの最大観察された血漿濃度（TMAX）の到達時間
時間枠：二重盲検期間：投与前、0.5、1、3、5、7時間投与後36
二重盲検期間：投与前、0.5、1、3、5、7時間投与後36
二重盲検期間：Mitapivatの最後の定量化可能濃度（TLAST）の時間
時間枠：二重盲検期間：投与前、0.5、1、3、5、7時間投与後36
二重盲検期間：投与前、0.5、1、3、5、7時間投与後36
二重盲検期間：アデノシン三リン酸（ATP）の血中濃度
時間枠：二重盲検期間：1日目の事前投与。 12週目の事前投与。 24週目の事前投与。前投与、0.5、1、3、5、36週目の投与後7時間
二重盲検期間：1日目の事前投与。 12週目の事前投与。 24週目の事前投与。前投与、0.5、1、3、5、36週目の投与後7時間
二重盲検期間：2,3-ジフォスホグリセ酸（2,3-dpg）の血中濃度
時間枠：二重盲検期間：1日目の事前投与。 12週目の事前投与。 24週目の事前投与。前投与、0.5、1、3、5、36週目の投与後7時間
二重盲検期間：1日目の事前投与。 12週目の事前投与。 24週目の事前投与。前投与、0.5、1、3、5、36週目の投与後7時間
Double-blind Period: Percentage of Participants Who Achieved TRR2
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Agios Pharmaceuticals, Inc.

捜査官

  • スタディチェア：Medical Affairs、Agios Pharmaceuticals, Inc.

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年11月30日

一次修了 (実際)

2024年4月11日

研究の完了 (推定)

2029年6月1日

試験登録日

最初に提出

2021年2月18日

QC基準を満たした最初の提出物

2021年2月22日

最初の投稿 (実際)

2021年2月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月28日

QC基準を満たした最後の更新が送信されました

2026年10月27日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • AG348-C-018
  • 2021-000212-34 (EudraCT番号)
  • 2024-512747-23-00 (Ctis)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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