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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 2 단계
확장된 액세스
연락처 및 위치
연구 장소
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Groningen, 네덜란드, 9713 GZ
- Universitair Medisch Centrum Groningen
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Rotterdam, 네덜란드, 3083 AN
- Ikazia Ziekenhuis
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Auckland, 뉴질랜드, 1023
- Auckland City Hospital
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Christchurch, 뉴질랜드, 8011
- Christchurch Hospital
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Dunedin, 뉴질랜드, 9016
- Dunedin Hospital
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Hamilton, 뉴질랜드, 3204
- Waikato Hospital
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Berlin, 독일, 14050
- DRK Kliniken Berlin Westend
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Frankfurt, 독일, 60594
- Crohn-Colitis-Centre Rhein-Main
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Keil, 독일, 24105
- Universitätsklinikum Schleswig-Holstein
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Minden, 독일, 32423
- Gastroenterologische Praxis Minden
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Kazan, 러시아 연방, 420064
- Republican Clinical Hospital
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Moscow, 러시아 연방, 115088
- Stolitsa-Medikl, LLC
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Rostov on Don, 러시아 연방, 344022
- SEIHPE Rostov State Medical University of MoH of RF
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Saratov, 러시아 연방, 410053
- Regional Clinical Hospital
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St Petersburg, 러시아 연방, 129329
- Russian Medical Military Academy na SMKirov
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Alabama
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Dothan, Alabama, 미국, 36305
- Digestive Health Specialists of the Southeast
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California
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Los Angeles, California, 미국, 90045
- Southern California Research Institute Medical Group, Inc.
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Connecticut
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Bristol, Connecticut, 미국, 06010
- Connecticut Clinical Research Foundation
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Florida
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Boynton Beach, Florida, 미국, 33426
- Consultants for Clinical Research of South Florida
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DeLand, Florida, 미국, 32720
- Avail Clinical Research, LLC
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Lauderdale Lakes, Florida, 미국, 33319
- Precision Clinical Research, LLC
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Miami, Florida, 미국, 33126
- Pharmax Research Clinic, Inc.
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Naples, Florida, 미국, 34102
- Gastroenterology Group Of Naples
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Port Orange, Florida, 미국, 32127
- Advanced Medical Research Center
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Illinois
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Chicago, Illinois, 미국, 60637
- University of Chicago Medical Center
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Iowa
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Iowa City, Iowa, 미국, 52242
- University of Iowa Hospitals and Clinics
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Kentucky
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Louisville, Kentucky, 미국, 40202
- University of Louisville
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Massachusetts
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Worcester, Massachusetts, 미국, 01655
- UMASS Medical Center
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Michigan
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Chesterfield, Michigan, 미국, 48047
- Clinical Research Institute of Michigan, LLC
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Troy, Michigan, 미국, 48098
- Center for Digestive Health Research
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Mississippi
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Flowood, Mississippi, 미국, 39232
- Gastrointestinal Associates PA
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New York
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Great Neck, New York, 미국, 11021
- NYU Langone Long Island Clinical Research Associates
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Ohio
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Cincinnati, Ohio, 미국, 45219
- Consultants for Clinical Research
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Tennessee
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Nashville, Tennessee, 미국, 37211
- Quality Medical Research
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Texas
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Live Oak, Texas, 미국, 78233
- Digestive Research Center/ Gastroenterology Consultants of San Antonio
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Pasadena, Texas, 미국, 77505
- Digestive Health Specialist of Tyler
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San Antonio, Texas, 미국, 78229
- San Antonio Gastroenterology
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Utah
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Salt Lake City, Utah, 미국, 84132
- University of Utah
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Washington
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Seattle, Washington, 미국, 98195
- University of Washington Medical Center
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Seattle, Washington, 미국, 98104
- Harborview Medical Center
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Plovdiv, 불가리아, 4002
- Multiprofile Hospital for Active Treatment Kaspela
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Sofia, 불가리아, 1303
- Medical Center Asklepion - Humane Medicine Research EOOD
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Sofia, 불가리아, 1431
- University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
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Sofia, 불가리아, 1407
- University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia
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Sofia, 불가리아, 1527
- University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
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Sofia, 불가리아, 1784
- Clinic of Gastroenterology
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Varna, 불가리아, 9010
- Multiprofile Hospital for Active Treatment Sveta Marina EAD
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Ivano-Frankivsk, 우크라이나, 76018
- Ivano-Frankivsk Central City Clinical Hospital
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Ivano-Frankivsk, 우크라이나, 58001
- Regional Clinical Hospital, Gastroenterology department, State Higher Education Institute Ivano-Frankivsk National Medical University
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Ivano-Frankivsk, 우크라이나, 76008
- Ivano-Frankivsk Regional Clinical Hospital
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Kharkiv, 우크라이나, 61037
- Kharkiv City Clinical Hospital 2
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Kirovograd, 우크라이나, 25006
- Private Enterprise Private Manufacture Company Acinus
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Kremenchuk, 우크라이나, 39617
- Kremenchuk City Hospital # 1 n.a O.T.Bohaievskyi
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Lviv, 우크라이나, 79059
- Lviv Emergency Clinical Hospital, Therapeutics Department No. 1
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Odesa, 우크라이나, 65025
- Municipal Institution Odesa Regional Clinical Hospital
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Uzhgorod, 우크라이나, 88000
- Central City Clinical Hospital
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Vinnytsia, 우크라이나, 21018
- Vinnytsia Regional Clinical Hospital n a M I Pyrohov
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Zaporizhzhia, 우크라이나, 69600
- Municipal Institution Zaporizhzhia
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Bologna, 이탈리아, 40138
- Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi
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Milan, 이탈리아, 20089
- IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center
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Palermo, 이탈리아, 90146
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello
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Roma, 이탈리아, 00168
- Complesso Integrato Columbus
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Roma, 이탈리아, 00133
- Fondazione Ptv Policlinico Tor Vergata
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Brno, 체코, 656 91
- Fakultni nemocnice u sv Anny v Brne
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Hradec Kralove, 체코, 500 05
- Fakultni nemocnice Hradec Kralove
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Hradec Králové, 체코, 500 12
- Hepato-Gastroenterologie HK, s. r. o.
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Slany, 체코, 274 01
- Nemocnice Slany
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Manitoba
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Winnipeg, Manitoba, 캐나다, R3A 1R9
- Winnipeg Regional Health Authority - Health Sciences Centre
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Ontario
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Hamilton, Ontario, 캐나다, L8N 3Z5
- Hamilton Health Sciences Corporation, McMaster University Medical Centre
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Bialystok, 폴란드, 15-276
- Uniwersytecki Szpital Kliniczny w Bialymstoku
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Bydgoszcz, 폴란드, 85-794
- Osrodek Badan Klinicznych CLINSANTE S.C.
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Czestochowa, 폴란드, 42 202
- Centrum Medyczne Sw. Lukasza
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Katowice, 폴란드, 40 659
- Economicus - NZOZ ALL-MEDICUS
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Sopot, 폴란드, 81-756
- Endoskopia Sp. z o.o.
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Szczecin, 폴란드, 71-685
- Sonomed Sp. z o.o.
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Torun, 폴란드, 40 659
- Gastromed Kopon Zmudzinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii Spec. Gabinety Lekarskie
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Warsaw, 폴란드, 00-632
- Centrum Zdrowia Matki, Dziecka i Mlodziezy
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Warszawa, 폴란드, 03-563
- Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
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Wroclaw, 폴란드, 03-580
- Lexmedica Drubajlo Hanna
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Wroclaw, 폴란드, 53-333
- ARS Médica
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Amiens, 프랑스, 80054
- Amiens University Hospital
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Clichy, 프랑스, 92110
- Hôpital Beaujon
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Nantes, 프랑스, 602 00
- CHRU Nantes
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Nice, 프랑스, 06202
- CHU de Nice Archet I
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Pierre Bénite, 프랑스, 69495
- Centre Hospitalier Lyon Sud
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Saint Priest en Jarez, 프랑스, 42055
- Centre Hospitalier Universitaire de Saint Etienne
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Vandoeuvre les Nancy, 프랑스, 54511
- CHRU Nancy
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Budapest, 헝가리, 1139
- Endomedix Kft.
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Budapest, 헝가리, 1136
- Pannonia Maganorvosi Centrum Kft.
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Debrecen, 헝가리, 4025
- Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja
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Mosonmagyaróvár, 헝가리, 9200
- Karolina Korhaz Rendelointezet
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Szeged, 헝가리, 6720
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
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Szekszárd, 헝가리, 7100
- Tolna Megyei Balassa János Kórház
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Vác, 헝가리, 2600
- Javorszky Odon Korhaz
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New South Wales
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Concord, New South Wales, 호주, 2139
- Concord Repatriation General Hospital
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Liverpool, New South Wales, 호주, 2170
- Liverpool Hospital
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Queensland
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South Brisbane, Queensland, 호주, 4101
- Mater Adult Hospital
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Victoria
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Footscray, Victoria, 호주, 3011
- Footscray Hospital
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Parkville, Victoria, 호주, 3050
- Royal Melbourne Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
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: 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) |
다른 이름들:
|
|
실험적: 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) |
다른 이름들:
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위약 비교기: 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) |
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score (TMS) at Week 12
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score and the Reduction in the Rectal Bleeding Subscore at Week 12
기간: Week 12
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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
기간: 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
기간: Week 12
|
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
기간: Week 12
|
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
기간: 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
기간: 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
기간: Week 8
|
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
기간: 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
기간: 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
|
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
|
|
The Number of Participants Who Discontinued Apremilast Due to Treatment Emergent Adverse Events During the Placebo-Controlled Period
기간: 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
|
|
The Number of Participants Who Experienced TEAEs During the Apremilast (APR) Exposure Period (Active Treatment Phase) Through Week 52
기간: 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)
기간: 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.
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CC-10004-UC-001
- 2014-002981-64 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구 프로토콜
- 통계 분석 계획(SAP)
- 정보에 입각한 동의서(ICF)
- 임상 연구 보고서(CSR)
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. .
위약에 대한 임상 시험
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Shanghai Lanyi Therapeutics Co., Ltd.완전한
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University of Texas Southwestern Medical Center아직 모집하지 않음
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Universidad Autonoma de Zacatecas모집하지 않고 적극적으로