Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis (UC)
A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Apremilast (CC-10004) for Treatment of Subjects With Active Ulcerative Colitis
調査の概要
詳細な説明
Approximately 165 participants (55 subjects per arm) will be randomized in a 1:1:1 ratio to receive oral apremilast (30 mg BID or 40 mg BID), or identically appearing placebo BID for up to 12 weeks, followed by 40 weeks of blinded treatment with apremilast (30 mg BID or 40 mg BID).
At the end of the Blinded Active-treatment Phase (Week 52), participants who have a Mayo endoscopy score ≤ 1 will have the opportunity to participate in the Extension Phase. Participants enrolled in the Extension Phase will receive apremilast for an additional 52 weeks (Weeks 52 to 104). With the implementation of Amendment 4, participants entering the Extension Phase will receive apremilast 30 mg BID. Subjects currently in the Extension Phase who are receiving apremilast 40 mg BID will be switched to 30 mg BID at the next scheduled visit.
研究の種類
入学 (実際)
段階
- フェーズ2
アクセスの拡大
連絡先と場所
研究場所
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Alabama
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Dothan、Alabama、アメリカ、36305
- Digestive Health Specialists of the Southeast
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California
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Los Angeles、California、アメリカ、90045
- Southern California Research Institute Medical Group, Inc.
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Connecticut
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Bristol、Connecticut、アメリカ、06010
- Connecticut Clinical Research Foundation
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Florida
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Boynton Beach、Florida、アメリカ、33426
- Consultants for Clinical Research of South Florida
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DeLand、Florida、アメリカ、32720
- Avail Clinical Research, LLC
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Lauderdale Lakes、Florida、アメリカ、33319
- Precision Clinical Research, LLC
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Miami、Florida、アメリカ、33126
- Pharmax Research Clinic, Inc.
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Naples、Florida、アメリカ、34102
- Gastroenterology Group Of Naples
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Port Orange、Florida、アメリカ、32127
- Advanced Medical Research Center
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Illinois
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Chicago、Illinois、アメリカ、60637
- University of Chicago Medical Center
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Iowa
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Iowa City、Iowa、アメリカ、52242
- University of Iowa Hospitals and Clinics
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Kentucky
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Louisville、Kentucky、アメリカ、40202
- University of Louisville
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Massachusetts
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Worcester、Massachusetts、アメリカ、01655
- UMASS medical center
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Michigan
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Chesterfield、Michigan、アメリカ、48047
- Clinical Research Institute of Michigan, LLC
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Troy、Michigan、アメリカ、48098
- Center for Digestive Health Research
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Mississippi
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Flowood、Mississippi、アメリカ、39232
- Gastrointestinal Associates PA
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New York
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Great Neck、New York、アメリカ、11021
- NYU Langone Long Island Clinical Research Associates
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Ohio
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Cincinnati、Ohio、アメリカ、45219
- Consultants for Clinical Research
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Tennessee
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Nashville、Tennessee、アメリカ、37211
- Quality Medical Research
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Texas
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Live Oak、Texas、アメリカ、78233
- Digestive Research Center/ Gastroenterology Consultants of San Antonio
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Pasadena、Texas、アメリカ、77505
- Digestive Health Specialist of Tyler
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San Antonio、Texas、アメリカ、78229
- San Antonio Gastroenterology
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Utah
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Salt Lake City、Utah、アメリカ、84132
- University of Utah
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Washington
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Seattle、Washington、アメリカ、98195
- University of Washington Medical Center
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Seattle、Washington、アメリカ、98104
- Harborview Medical Center
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Bologna、イタリア、40138
- Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi
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Milan、イタリア、20089
- IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center
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Palermo、イタリア、90146
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello
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Roma、イタリア、00168
- Complesso Integrato Columbus
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Roma、イタリア、00133
- Fondazione PTV Policlinico Tor Vergata
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Ivano-Frankivsk、ウクライナ、76018
- Ivano-Frankivsk Central City Clinical Hospital
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Ivano-Frankivsk、ウクライナ、58001
- Regional Clinical Hospital, Gastroenterology department, State Higher Education Institute Ivano-Frankivsk National Medical University
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Ivano-Frankivsk、ウクライナ、76008
- Ivano-Frankivsk Regional Clinical Hospital
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Kharkiv、ウクライナ、61037
- Kharkiv City Clinical Hospital 2
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Kirovograd、ウクライナ、25006
- Private Enterprise Private Manufacture Company Acinus
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Kremenchuk、ウクライナ、39617
- Kremenchuk City Hospital # 1 n.a O.T.Bohaievskyi
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Lviv、ウクライナ、79059
- Lviv Emergency Clinical Hospital, Therapeutics Department No. 1
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Odesa、ウクライナ、65025
- Municipal Institution Odesa Regional Clinical Hospital
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Uzhgorod、ウクライナ、88000
- Central City Clinical Hospital
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Vinnytsia、ウクライナ、21018
- Vinnytsia Regional Clinical Hospital n a M I Pyrohov
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Zaporizhzhia、ウクライナ、69600
- Municipal Institution Zaporizhzhia
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Groningen、オランダ、9713 GZ
- Universitair Medisch Centrum Groningen
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Rotterdam、オランダ、3083 AN
- Ikazia Ziekenhuis
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New South Wales
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Concord、New South Wales、オーストラリア、2139
- Concord Repatriation General Hospital
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Liverpool、New South Wales、オーストラリア、2170
- Liverpool Hospital
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Queensland
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South Brisbane、Queensland、オーストラリア、4101
- Mater Adult Hospital
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Victoria
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Footscray、Victoria、オーストラリア、3011
- Footscray Hospital
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Parkville、Victoria、オーストラリア、3050
- Royal Melbourne Hospital
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Manitoba
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Winnipeg、Manitoba、カナダ、R3A 1R9
- Winnipeg Regional Health Authority - Health Sciences Centre
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Ontario
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Hamilton、Ontario、カナダ、L8N 3Z5
- Hamilton Health Sciences Corporation, McMaster University Medical Centre
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Brno、チェコ、656 91
- Fakultni nemocnice u sv Anny v Brne
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Hradec Kralove、チェコ、500 05
- Fakultni Nemocnice Hradec Kralove
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Hradec Králové、チェコ、500 12
- Hepato-Gastroenterologie HK, s. r. o.
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Slany、チェコ、274 01
- Nemocnice Slany
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Berlin、ドイツ、14050
- DRK Kliniken Berlin Westend
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Frankfurt、ドイツ、60594
- Crohn-Colitis-Centre Rhein-Main
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Keil、ドイツ、24105
- Universitätsklinikum Schleswig-Holstein
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Minden、ドイツ、32423
- Gastroenterologische Praxis Minden
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Auckland、ニュージーランド、1023
- Auckland City Hospital
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Christchurch、ニュージーランド、8011
- Christchurch Hospital
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Dunedin、ニュージーランド、9016
- Dunedin Hospital
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Hamilton、ニュージーランド、3204
- Waikato Hospital
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Budapest、ハンガリー、1139
- Endomedix Kft.
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Budapest、ハンガリー、1136
- Pannonia Maganorvosi Centrum Kft.
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Debrecen、ハンガリー、4025
- Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja
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Mosonmagyaróvár、ハンガリー、9200
- Karolina Korhaz Rendelointezet
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Szeged、ハンガリー、6720
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
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Szekszárd、ハンガリー、7100
- Tolna Megyei Balassa Janos Korhaz
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Vác、ハンガリー、2600
- Jávorszky Ödön Kórház
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Amiens、フランス、80054
- Amiens University Hospital
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Clichy、フランス、92110
- Hôpital Beaujon
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Nantes、フランス、602 00
- CHRU Nantes
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Nice、フランス、06202
- CHU de Nice Archet I
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Pierre Bénite、フランス、69495
- Centre Hospitalier Lyon Sud
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Saint Priest en Jarez、フランス、42055
- Centre Hospitalier Universitaire de Saint Etienne
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Vandoeuvre les Nancy、フランス、54511
- CHRU Nancy
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Plovdiv、ブルガリア、4002
- Multiprofile Hospital for Active Treatment Kaspela
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Sofia、ブルガリア、1303
- Medical Center Asklepion - Humane Medicine Research EOOD
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Sofia、ブルガリア、1431
- University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
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Sofia、ブルガリア、1407
- University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia
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Sofia、ブルガリア、1527
- University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
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Sofia、ブルガリア、1784
- Clinic of Gastroenterology
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Varna、ブルガリア、9010
- Multiprofile Hospital for Active Treatment Sveta Marina EAD
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Bialystok、ポーランド、15-276
- Uniwersytecki Szpital Kliniczny w Bialymstoku
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Bydgoszcz、ポーランド、85-794
- Osrodek Badan Klinicznych CLINSANTE S.C.
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Czestochowa、ポーランド、42 202
- Centrum Medyczne Sw. Lukasza
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Katowice、ポーランド、40 659
- Economicus - NZOZ ALL-MEDICUS
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Sopot、ポーランド、81-756
- Endoskopia Sp. z o.o.
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Szczecin、ポーランド、71-685
- Sonomed Sp. z o.o.
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Torun、ポーランド、40 659
- Gastromed Kopon Zmudzinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii Spec. Gabinety Lekarskie
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Warsaw、ポーランド、00-632
- Centrum Zdrowia Matki, Dziecka i Mlodziezy
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Warszawa、ポーランド、03-563
- Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
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Wroclaw、ポーランド、03-580
- Lexmedica Drubajlo Hanna
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Wroclaw、ポーランド、53-333
- ARS Médica
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Kazan、ロシア連邦、420064
- Republican Clinical Hospital
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Moscow、ロシア連邦、115088
- Stolitsa-Medikl, LLC
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Rostov on Don、ロシア連邦、344022
- SEIHPE Rostov State Medical University of MoH of RF
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Saratov、ロシア連邦、410053
- Regional Clinical Hospital
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St Petersburg、ロシア連邦、129329
- Russian Medical Military Academy na SMKirov
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参加基準
適格基準
就学可能な年齢
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:
Subjects must satisfy the following criteria to be enrolled in the study:
- Male or female aged 18 and over at the time of signing the informed consent.
- Must understand and voluntarily sign an informed consent form prior to any study related assessments/procedures being conducted.
- Diagnosis of ulcerative colitis (UC) with a duration of at least 3 months prior to the Screening Visit..
- Total Mayo Score (TMS) ≥ 6 to ≤ 11 (range: 0-12) at baseline, prior to randomization in the study.
- Endoscopic subscore ≥ 2 (range: 0-3) on the Mayo score prior to randomization in the study.
- Subjects must have had a therapeutic failure, been intolerant to, or have a contraindication to, at least one of the following: oral aminosalicylates (ie, 5-aminosalicylic acid [5-ASA] compounds or sulfasalazine [SSZ]), budesonide, systemic corticosteroids, or immunosuppressants (eg, 6-mercaptopurine [6-MP], azathioprine [AZA], or methotrexate [MTX]).
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
- Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis.
- Ulcerative colitis restricted to the distal 15 cm or less (eg, ulcerative proctitis).
- Subjects who have had surgery as a treatment for UC or who, in the opinion of the Investigator, are likely to require surgery for UC during the study.
- Clinical signs suggestive of fulminant colitis or toxic megacolon.
- Prior use of any tumor necrosing factor (TNF) inhibitor (or any biologic agent).
- Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine or thalidomide.
- Use of intravenous (IV) corticosteroids within 2 weeks of the Screening Visit.
- Use of immunosuppressants (AZA, 6-MP or MTX) within 8 weeks of the Screening Visit.
- Use of topical treatment with 5-ASA or corticosteroid enemas or suppositories within 2 weeks of the Screening Visit.
- History of any clinically significant neurological, renal, hepatic, gastrointestinal, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that, in the investigator's opinion, would preclude participation in the 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：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 |
|---|---|
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実験的：Apremilast 30 mg PO BID
Apremilast 30 mg by mouth (PO) twice a day (BID) for 12 weeks After 12 weeks:
After 52 weeks, participants who are eligible for the Extension Phase will continue to receive the same dose of apremilast assigned at Wk 12 (30 mg BID or 40 mg BID) for an additional 52 weeks (Wk 104) |
他の名前：
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実験的：Apremilast 40 mg PO BID
Apremilast 40 mg by mouth (PO) twice a day (BID) for 12 weeks After 12 weeks, participants assigned to the 40 mg BID dose of apremilast at baseline will continue to receive apremilast 40 mg BID for an additional 40 weeks (Wk 52) After 52 weeks, participants who are eligible for the extension Phase will continue to receive apremilast 40 mg BID for an additional 52 weeks (Wk 104) |
他の名前：
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プラセボコンパレーター：Placebo BID
Identically matching placebo by mouth (PO) twice a day (BID) for 12 weeks. After 12 weeks all participants randomized to placebo at baseline will be re-randomized to receive apremilast 30 mg or 40 mg BID for an additional 40 weeks (Wk 52) After Wk 52, participants who are eligible for the extension phase will continue to receive the same dose of apremilast assigned at Wk 12 (30 mg BID or 40 mg BID) for an additional 52 weeks (Wk 104) |
他の名前：
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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 |
|---|---|---|
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Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score (TMS) at Week 12
時間枠：Week 12
|
Clinical remission was defined as a total Mayo score ≤ 2 points, with no individual subscore exceeding 1 point. The TMS is an instrument designed to measure disease activity of UC. The Mayo score ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease.
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Week 12
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score and the Reduction in the Rectal Bleeding Subscore at Week 12
時間枠：Week 12
|
Clinical response was defined as a decrease from baseline in the TMS of at least 3 points and at least 30%, along with a reduction in the rectal bleeding subscore (RBS) of at least 1 point or an absolute RBS of ≤ 1. The TMS is an instrument designed to measure disease activity of UC. The Mayo score ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease.
Rectal bleeding (subscore 0-3) was defined as: 0 = No blood seen
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Week 12
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Percentage of Participants Who Achieved an Endoscopic Remission at Week 12
時間枠：Week 12
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An endoscopic remission was defined as a Mayo endoscopic subscore (MES) of 0 at Week 12. The MES subscore findings were defined as: 0 = Normal or inactive disease
The endoscopy subscores consisted of findings that were centrally read through proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease. Two-sided 95% CIs for the within-group percentage were based on the Wilson score method. |
Week 12
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Percentage of Participants Who Achieved an Endoscopic Response at Week 12
時間枠：Week 12
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An endoscopic response is defined as a decrease from baseline of at least 1 point in the MES at Week 12. The Mayo endoscopy subscore findings were defined as: 0 = Normal or inactive disease
The endoscopy subscores consisted of findings that were centrally read through proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease. Two-sided 95% CIs for the within-group percentage were based on the Wilson score method. |
Week 12
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Percentage of Participants Who Achieved a Rectal Bleeding Subscore (RBS) of ≤ 1 at Week 12
時間枠：Week 12
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The RBS was measured as: 0 = No blood seen
The daily bleeding score represents the most severe bleeding of the day. Two-sided 95% CI for the within-group proportions are based on the Wilson score method. |
Week 12
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Percentage of Participants Who Achieved Clinical Remission in the Modified Mayo Subscore (MMS) at Week 12
時間枠：Week 12
|
Clinical remission was defined as a modified Mayo score of ≤ 2, with no individual subscore > 1, at Week 12.
The MMS was based on a modification of the total Mayo score (TMS) which included the stool frequency, rectal bleeding, and endoscopic subscores of the TMS and excluded the Physician's Global Assessment (PGA) subscore, since this was a global measure that is subjective in nature.
The MMS ranges from 0 to 9 points with higher scores indicating greater disease severity.
The endoscopy subscores was centrally reviewed.
Two-sided confidence intervals for the within-group percentage were based on the Wilson score method.
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Week 12
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Percentage of Participants Who Achieved Clinical Response in the Modified Mayo Subscore (MMS) at Week 12
時間枠：Week 12
|
Clinical response in the MMS was defined as a decrease from baseline in the MMS of at least 2 points and at least 25%, along with a reduction in the RBS of at least 1 point or an absolute RBS ≤ 1. The MMS was based on the stool frequency, rectal bleeding, and endoscopic subscores of the TMS and excluded the PGA subscore. The MMS ranges from 0 to 9 points with higher scores indicating greater disease severity. The RBS was measured as: 0 = No blood seen
The daily bleeding score represents the most severe bleeding of the day. The endoscopy subscores was centrally reviewed. Two-sided confidence intervals for the within-group percentage were based on the Wilson score method. |
Week 12
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Percentage of Participants Who Achieved Clinical Remission in the Partial Mayo Subscore (PMS) With no Individual Subscore >1 at Week 8
時間枠：Week 8
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Clinical remission in the partial Mayo subscore was defined as a PMS of 2 points or lower, with no individual subscore >1. The PMS is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores: Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease). Two-sided 95% CI for the within-group proportions are based on the Wilson score method. |
Week 8
|
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Percentage of Participants Who Achieved Clinical Response in the Partial Mayo Subscore at Week 8
時間枠：Week 8
|
Clinical response in the PMS was defined as a decrease from baseline in PMS of at least 2 points and at least 25%, with an accompanying decrease in the RBS of at least 1 point or an absolute RBS of 0 or 1. The PMS score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores: Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease). Two-sided 95% CI for the within-group proportions are based on the Wilson score method. |
Week 8
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The Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase
時間枠：From the first dose of investigational product (IP) and no later than 28 days after the last dose of IP for those who had completed the study or discontinued (D/C) early; maximum duration of exposure to treatment was 12.00 weeks
|
A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of apremilast and up to 28 days after the last apremilast dose or the last follow-up date, whichever occurred earlier.
A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.
The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain
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From the first dose of investigational product (IP) and no later than 28 days after the last dose of IP for those who had completed the study or discontinued (D/C) early; maximum duration of exposure to treatment was 12.00 weeks
|
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The Number of Participants Who Discontinued Apremilast Due to Treatment Emergent Adverse Events During the Placebo-Controlled Period
時間枠：From the first dose of IP and no later than 28 days after the last dose of IP for those who had completed the study or discontinued early; median duration of exposure to treatment was 12.00 weeks
|
A TEAE was defined as any AE occurring or worsening on or after the first treatment of apremilast and up to 28 days after the last apremilast dose or the last follow-up date, whichever occurred earlier.
A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.
The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain.
|
From the first dose of IP and no later than 28 days after the last dose of IP for those who had completed the study or discontinued early; median duration of exposure to treatment was 12.00 weeks
|
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The Number of Participants Who Experienced TEAEs During the Apremilast (APR) Exposure Period (Active Treatment Phase) Through Week 52
時間枠：From first dose of IP and no later than 28 days after last dose of IP for those who completed the active treatment phase or D/C early; median duration of exposure = 41.00, 44.15 and 40.00 weeks respectively for 30 mg, 40 mg and 30 mg/40 mg APR arms
|
A TEAE was defined as any AE occurring or worsening on or after the first treatment of apremilast and up to 28 days after the last apremilast dose or the last follow-up date, whichever occurred earlier.
A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.
The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain
|
From first dose of IP and no later than 28 days after last dose of IP for those who completed the active treatment phase or D/C early; median duration of exposure = 41.00, 44.15 and 40.00 weeks respectively for 30 mg, 40 mg and 30 mg/40 mg APR arms
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The Number of Participants Who Experienced TEAEs During Week 52 to Week 104 (Extension Phase)
時間枠：From the first dose of IP at Week 52 and no later than 28 days after the last dose of IP for those who completed the study or had discontinued early; median exposure of apremilast for the total apremilast group was 52 weeks.
|
A TEAE was defined as any AE occurring or worsening on or after the first treatment of apremilast and up to 28 days after the last apremilast dose or the last follow-up date, whichever occurred earlier.
A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.
The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain
|
From the first dose of IP at Week 52 and no later than 28 days after the last dose of IP for those who completed the study or had discontinued early; median exposure of apremilast for the total apremilast group was 52 weeks.
|
協力者と研究者
スポンサー
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 (実際)
研究の完了 (実際)
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 (見積もり)
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
- CC-10004-UC-001
- 2014-002981-64 (EudraCT番号)
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
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- 研究プロトコル
- 統計分析計画 (SAP)
- インフォームド コンセント フォーム (ICF)
- 臨床試験報告書（CSR）
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。