Genentech および/または F. Hoffman-La Roche スポンサー付き研究に以前に登録されていた参加者を対象としたロールオーバー研究 (UmbrellaMAX)
Genentech および/または F. Hoffmann-La Roche Ltd の後援による研究に以前に登録された患者を対象とした非盲検多施設延長研究
The purpose of this extension study is to provide continued treatment with Roche investigational medicinal product (IMP[s]) monotherapy or Roche IMP(s) combined with other agent(s) or comparator agent(s) for eligible participants with cancer who are still on study treatment at the time of roll-over from the parent study and who do not have access to the study treatment locally.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
研究連絡先のバックアップ
- 名前：Reference Study ID Number: BX44273 https://forpatients.roche.com/ No attachments to email below.
- 電話番号：888-662-6728 (U.S. Only)
- メール：global-roche-genentech-trials@gene.com
研究場所
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Leicester、イギリス、LE1 5WW
- 募集
- Leicester Royal Infirmary
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Surrey、イギリス、SM2 5PT
- 完了
- Royal Marsden Hospital - Surrey
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Kyiv、ウクライナ、02000
- 募集
- Arensia Exploratory Medicine - Ukraine
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Ontario
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Toronto、Ontario、カナダ、M5G 1Z5
- 募集
- Princess Margaret Cancer Center
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Asvestochóri、ギリシャ、570 10
- 募集
- General Hospital "G.Papanikolaou"
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Cholargós、ギリシャ、155 62
- 募集
- Metropolitan General Hospital
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San José、コスタリカ、10103
- 積極的、募集していない
- Clinica CIMCA
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San José、コスタリカ、10108
- 積極的、募集していない
- ICIMED Instituto de Investigación en Ciencias Médicas
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Bangkok、タイ、10700
- 募集
- Siriraj Hospital
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Bangkok、タイ、10330
- 積極的、募集していない
- Chulalongkorn Hospital
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Chiang Mai、タイ、50200
- 積極的、募集していない
- Maharaj Nakorn Chiangmai Hospital
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Bordeaux、フランス、33076
- 募集
- Institut Bergonie
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Caen、フランス、14076
- 募集
- Centre Francois Baclesse
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Dijon、フランス、21000
- 募集
- Institut de Cancérologie de Bourgogne
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Lyon、フランス、69373
- 募集
- Centre Leon Berard
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Marseille、フランス、13005
- 募集
- Hopital de la Timone
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Montpellier、フランス、34298
- 募集
- Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
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Nantes、フランス、44093
- 募集
- CHU de Nantes - Hotel Dieu
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Nîmes、フランス、30029
- 完了
- Institut de cancerologie du Gard
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Paris、フランス、75005
- 募集
- Institut Curie
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Paris、フランス、75970
- 募集
- Hopital Tenon
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Saint-Herblain、フランス、44805
- 募集
- ICO - Site René Gauducheau
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Toulouse、フランス、31059
- 募集
- Institut Claudius Regaud
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Vandœuvre-lès-Nancy、フランス、54511
- 募集
- Hopitaux de Brabois - Gastro-Entereologie
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Villejuif、フランス、94800
- 募集
- Gustave Roussy
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Bouches-du-Rhône
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Marseille、Bouches-du-Rhône、フランス、13005
- 募集
- AP-HM- Hôpital de La Timone
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Charleroi、ベルギー、6060
- 完了
- GHdC Site Les Viviers
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Kortrijk、ベルギー、8500
- 積極的、募集していない
- AZ Groeninge
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Leuven、ベルギー、3000
- 積極的、募集していない
- UZ Leuven Gasthuisberg
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Leuven、ベルギー、3000
- 完了
- UZ Leuven Gasthuisberg
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Gda?sk、ポーランド、80-214
- 募集
- Uniwersyteckie Centrum Kliniczne
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Koszalin、ポーランド、75-581
- 募集
- Szpital Wojewódzki im. Miko?aja Kopernika
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Warsaw、ポーランド、02-781
- 募集
- Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
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Durango、メキシコ、34000
- 積極的、募集していない
- Consultorio de Especialidad en Urologia Privado
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Sinaloa
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Culiacán、Sinaloa、メキシコ
- 積極的、募集していない
- Centro Medico Culiacan SA de CV
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Yucatán
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Mérida、Yucatán、メキシコ、97070
- 完了
- Medical Care & Research
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Moscow Oblast
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Moscow、Moscow Oblast、ロシア、117997
- 積極的、募集していない
- Russian Scientific Center of Roentgenoradiology
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Moscow、Moscow Oblast、ロシア、125248
- 募集
- P.A. Herzen Oncological Inst.
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Moscow、Moscow Oblast、ロシア、121205
- 募集
- Moscow City Oncology Hospital #62
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Moskva、Moscow Oblast、ロシア、119991
- 募集
- I.M.Sechenov First Moscow State Medical University (1st MSMU)
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Beijing、中国、100142
- 募集
- Beijing Cancer Hospital
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Changchun、中国、130021
- 募集
- the First Hospital of Jilin University
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Chengdu、中国、610041
- 募集
- West China Hospital of Sichuan University
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Guangzhou、中国、510515
- 募集
- Nanfang Hospital, Southern Medical University
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Guangzhou、中国、510000
- 募集
- Cancer Center of Guangzhou Medical University
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Hangzhou、中国、310022
- 募集
- Zhejiang Cancer Hospital
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Hangzhou、中国、310014
- 募集
- Zhejiang People's Hospital
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Hangzhou、中国、310016
- 募集
- Sir Run Run Shaw Hospital Zhejiang University
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Harbin、中国、150081
- 募集
- Harbin Medical University Cancer Hospital
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Hefei、中国、230601
- 募集
- The Second Affiliated Hospital of Anhui Medical University
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Meizhou、中国、514031
- 募集
- Meizhou People's Hospital
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Nanchang、中国、330052
- 募集
- The 1st Affiliated Hospital of Nanchang Unversity
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Nanjing、中国、210029
- 募集
- Jiangsu Province Hospital of Chinese Medicine
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Shanghai、中国、200030
- 募集
- Shanghai Chest Hospital
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Shanghai、中国、200120
- 募集
- Fudan University Shanghai Cancer Center
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Shanghai、中国、201104
- 募集
- Shanghai Geriatric Medical Center
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Tianjin、中国、300060
- 募集
- Tianjin Cancer Hospital
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Xi'an、中国、710061
- 募集
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Xi'an、中国、710126
- 募集
- Xi'an International Medical Center Hospital
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Xiamen、中国、361003
- 募集
- The First Affiliated Hospital of Xiamen University
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Xinxiang、中国
- 募集
- The First Affiliated Hospital of Xinxiang Medical University
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Zhengzhou、中国、450008
- 募集
- Henan Cancer Hospital
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Hubei
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Wuhan、Hubei、中国、430048
- 募集
- Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
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Shaanxi
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XI 'an City, Shaanxi Province、Shaanxi、中国、710061
- 募集
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200032
- 募集
- Fudan University Shanghai Cancer Center
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Taichung、台湾、407
- 募集
- Taichung Veterans General Hospital
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Tainan、台湾、70457
- 募集
- National Cheng Kung University Hospital
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Taipei、台湾、110
- 募集
- National Taiwan University Hospital
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Taoyuan、台湾、333
- 積極的、募集していない
- Chang Gung Memorial Hospital - Linkou
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Chiba、日本、277-8577
- 募集
- National Cancer Center Hospital East
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Chuo-ku, Fukuoka-shi、日本、810-8563
- 募集
- National Hospital Organization Kyushu Medical Center
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Fukuoka、日本、812-8582
- 募集
- Kyushu University Hospital
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Kanagawa、日本、232-0024
- 積極的、募集していない
- Yokohama City University Medical Center
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Kanagawa、日本、241-8515
- 完了
- Kanagawa Cancer Center
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Kanagawa、日本、213-8587
- 募集
- Toranomon Branch Hospital
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Kashiwa-shi、日本、277-8577
- 募集
- National Cancer Center Hospital East
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Matsuyama、日本、791-0280
- 募集
- National Hospital Organization Shikoku Cancer Center
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Numakunai、日本、028-3695
- 募集
- Iwate Medical University Hospital
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Saitama、日本、362-0806
- 募集
- Saitama Cancer Center
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Sakaishi、日本、591-8555
- 募集
- NHO Kinki-Chuo Chest Medical Center
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Goyang-si、韓国、10408
- 募集
- National Cancer Center
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Gyeonggi-do、韓国、13496
- 募集
- CHA Bundang Medical Center
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Seongnam-si、韓国、463-707
- 完了
- Seoul National University Bundang Hospital
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Seoul、韓国、06351
- 募集
- Samsung Medical Center
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Seoul、韓国、05505
- 積極的、募集していない
- Asan Medical Center
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Eligible for continuing Roche IMP-based therapy at the time of roll-over from the parent study, as per the parent study protocol OR
- Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study as per the parent study protocol, with no access to commercially available comparator agent
- First dose of study treatment in this extension study will be received within 7 days of the treatment interruption window allowed by the parent study
- Continue to benefit from the Roche IMP-based therapy or comparator at the time of roll-over from the parent study as assessed by the investigator
- Ability to comply with the extension study protocol, per Investigator's judgement
Exclusion Criteria:
- Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study
- Study treatment or comparator agent is commercially marketed in the participant's country for the participant-specific disease and is accessible to the participant
- Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this extension study
- Permanent discontinuation of all study treatment(s) or comparator agent(s) for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable)
- Ongoing SAE(s) that has not resolved to baseline level or Grade ≤1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study. Potential participants with an ongoing SAE that has not resolved to baseline level or Grade 1 may be enrolled at the investigator's discretion, provided the event is deemed clinically stable and the investigator documents that the potential clinical benefit outweighs the risk to the potential participant.
- Concurrent participation in any therapeutic clinical trial (other than the parent study)
研究計画
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：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Roche IMP(s) Monotherapy
Participants will continue to receive Roche IMP(s) monotherapy as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first. |
Ipatasertib will be administered as a monotherapy at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
他の名前：
Atezolizumab will be administered as a monotherapy and in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants' discontinuation from the parent study.
他の名前：
Bevacizumab will be administered as a monotherapy or in combination with atezolizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
他の名前：
Entrectinib will be administered as a monotherapy at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
他の名前：
Inavolisib will be administered as a monotherapy or in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
他の名前：
Divarasib will be administered as a monotherapy or in combination with atezolizumab or bevacizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
他の名前：
Giredestrant will be administered as a monotherapy or in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
他の名前：
|
|
実験的：Roche Combined Agents
Participants will continue to receive Roche IMP(s) in combination with other agent(s) as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first. |
Atezolizumab will be administered as a monotherapy and in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants' discontinuation from the parent study.
他の名前：
Bevacizumab will be administered as a monotherapy or in combination with atezolizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
他の名前：
Inavolisib will be administered as a monotherapy or in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
他の名前：
Divarasib will be administered as a monotherapy or in combination with atezolizumab or bevacizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
他の名前：
Tiragolumab in combination with atezolizumab will be administered at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
他の名前：
Tiragolumab and Atezolizumab in fixed dose combination administered intravenously (IV) at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
他の名前：
Giredestrant will be administered as a monotherapy or in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
他の名前：
|
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 |
時間枠 |
|---|---|
|
ロシュ IMP ベースの治療および/または比較薬剤に継続的にアクセスできる参加者の数
時間枠：最長約10年
|
最長約10年
|
|
国立がん研究所の有害事象共通用語基準 (NCI CTCAE) バージョン 5.0 に従って評価された、選択された有害事象を有する参加者の数と重症度
時間枠：最長約10年
|
最長約10年
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Clinical Trials、Hoffmann-La Roche
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- BX44273
- 2022-003414-36 (EudraCT番号)
- 2023 (米国 NIH グラント/契約)
- 2023-504263-16-00 (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?
IPD プランの説明
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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
米国FDA規制機器製品の研究
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。