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Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Subjects With Hepatitis C Related Liver Disease

2013년 10월 10일 업데이트: GlaxoSmithKline

Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a Plus Ribavirin

The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR).

연구 개요

상태

완전한

정황

만성 C형 간염

개입 / 치료

연구 유형

중재적

등록 (실제)

687

단계

3단계

연락처 및 위치

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

연구 장소

네덜란드
- - Amsterdam, 네덜란드, 1081 HV
    - GSK Investigational Site
  - Nijmegen, 네덜란드, 6525 GA
    - GSK Investigational Site
  - Rotterdam, 네덜란드, 3015 CE
    - GSK Investigational Site
대만
- - Kaohsiung, 대만, 80708
    - GSK Investigational Site
  - Taichung, 대만, 407
    - GSK Investigational Site
  - Tainan, 대만, 704
    - GSK Investigational Site
  - Taipei, 대만, 100
    - GSK Investigational Site
대한민국
- - Busan, 대한민국, 614-735
    - GSK Investigational Site
  - Incheon, 대한민국, 400-711
    - GSK Investigational Site
  - Seoul, 대한민국, 135-710
    - GSK Investigational Site
독일
- - Berlin, 독일, 13353
    - GSK Investigational Site
  - Berlin, 독일, 12203
    - GSK Investigational Site
- Baden-Wuerttemberg
  - Freiburg, Baden-Wuerttemberg, 독일, 79106
    - GSK Investigational Site
  - Heidelberg, Baden-Wuerttemberg, 독일, 69120
    - GSK Investigational Site
  - Stuttgart, Baden-Wuerttemberg, 독일, 70197
    - GSK Investigational Site
  - Ulm, Baden-Wuerttemberg, 독일, 89081
    - GSK Investigational Site
- Bayern
  - Deggendorf, Bayern, 독일, 94469
    - GSK Investigational Site
  - Hof/Saale, Bayern, 독일, 95028
    - GSK Investigational Site
  - Muenchen, Bayern, 독일, 81377
    - GSK Investigational Site
  - Regensburg, Bayern, 독일, 93053
    - GSK Investigational Site
  - Wuerzburg, Bayern, 독일, 97080
    - GSK Investigational Site
- Brandenburg
  - Beeskow, Brandenburg, 독일, 15848
    - GSK Investigational Site
- Hessen
  - Frankfurt, Hessen, 독일, 60590
    - GSK Investigational Site
  - Kassel, Hessen, 독일, 34127
    - GSK Investigational Site
- Niedersachsen
  - Goettingen, Niedersachsen, 독일, 37075
    - GSK Investigational Site
  - Hannover, Niedersachsen, 독일, 30159
    - GSK Investigational Site
  - Hannover, Niedersachsen, 독일, 30625
    - GSK Investigational Site
- Nordrhein-Westfalen
  - Aachen, Nordrhein-Westfalen, 독일, 52074
    - GSK Investigational Site
  - Bochum, Nordrhein-Westfalen, 독일, 44787
    - GSK Investigational Site
  - Bonn, Nordrhein-Westfalen, 독일, 53127
    - GSK Investigational Site
  - Dortmund, Nordrhein-Westfalen, 독일, 44263
    - GSK Investigational Site
  - Duesseldorf, Nordrhein-Westfalen, 독일, 40225
    - GSK Investigational Site
  - Essen, Nordrhein-Westfalen, 독일, 45122
    - GSK Investigational Site
  - Herne, Nordrhein-Westfalen, 독일, 44623
    - GSK Investigational Site
  - Koeln, Nordrhein-Westfalen, 독일, 50937
    - GSK Investigational Site
  - Leverkusen, Nordrhein-Westfalen, 독일, 51375
    - GSK Investigational Site
  - Muenster, Nordrhein-Westfalen, 독일, 48143
    - GSK Investigational Site
  - Siegen, Nordrhein-Westfalen, 독일, 57072
    - GSK Investigational Site
- Rheinland-Pfalz
  - Mainz, Rheinland-Pfalz, 독일, 55131
    - GSK Investigational Site
- Sachsen
  - Leipzig, Sachsen, 독일, 04103
    - GSK Investigational Site
  - Leipzig, Sachsen, 독일, 04129
    - GSK Investigational Site
- Sachsen-Anhalt
  - Halle, Sachsen-Anhalt, 독일, 06120
    - GSK Investigational Site
  - Magdeburg, Sachsen-Anhalt, 독일, 39120
    - GSK Investigational Site
러시아 연방
- - Moscow, 러시아 연방, 129110
    - GSK Investigational Site
  - Moscow, 러시아 연방, 110020
    - GSK Investigational Site
  - Mosocow, 러시아 연방, 117593
    - GSK Investigational Site
  - Smolensk, 러시아 연방, 214018
    - GSK Investigational Site
루마니아
- - Bucharest, 루마니아, 021105
    - GSK Investigational Site
  - Constanta, 루마니아, 900708
    - GSK Investigational Site
미국
- Alabama
  - Birmingham, Alabama, 미국, 35294-0005
    - GSK Investigational Site
- Arizona
  - Tucson, Arizona, 미국, 85750
    - GSK Investigational Site
- Arkansas
  - Little Rock, Arkansas, 미국, 72205-7199
    - GSK Investigational Site
- California
  - La Jolla, California, 미국, 92037
    - GSK Investigational Site
  - Los Angeles, California, 미국, 90017
    - GSK Investigational Site
  - Los Angeles, California, 미국, 90048
    - GSK Investigational Site
  - San Clemente, California, 미국, 92673
    - GSK Investigational Site
- Colorado
  - Aurora, Colorado, 미국, 80045
    - GSK Investigational Site
- Connecticut
  - New Haven, Connecticut, 미국, 06520
    - GSK Investigational Site
- District of Columbia
  - Washington, District of Columbia, 미국, 20010
    - GSK Investigational Site
  - Washington, District of Columbia, 미국, 20307
    - GSK Investigational Site
- Florida
  - Bradenton, Florida, 미국, 34209
    - GSK Investigational Site
  - Gainsville, Florida, 미국, 32610
    - GSK Investigational Site
  - Miami, Florida, 미국, 33136
    - GSK Investigational Site
  - Orlando, Florida, 미국, 32803
    - GSK Investigational Site
- Georgia
  - Atlanta, Georgia, 미국, 30309
    - GSK Investigational Site
- Hawaii
  - Honolulu, Hawaii, 미국, 96817
    - GSK Investigational Site
- Kentucky
  - Louisville, Kentucky, 미국, 40202
    - GSK Investigational Site
- Maryland
  - Baltimore, Maryland, 미국, 21202
    - GSK Investigational Site
- Massachusetts
  - Burlington, Massachusetts, 미국, 01805
    - GSK Investigational Site
  - Worcester, Massachusetts, 미국, 01655
    - GSK Investigational Site
- Michigan
  - Ann Arbor, Michigan, 미국, 48109
    - GSK Investigational Site
  - Detroit, Michigan, 미국, 48201
    - GSK Investigational Site
- Mississippi
  - Jackson, Mississippi, 미국, 39202
    - GSK Investigational Site
- Missouri
  - St. Louis, Missouri, 미국, 63110
    - GSK Investigational Site
- New York
  - Bronx, New York, 미국, 10468
    - GSK Investigational Site
  - Manhasset, New York, 미국, 11030
    - GSK Investigational Site
  - New York, New York, 미국, 10021
    - GSK Investigational Site
  - Rochester, New York, 미국, 14642
    - GSK Investigational Site
  - Syracuse, New York, 미국, 13210
    - GSK Investigational Site
  - Valhalla, New York, 미국, 10595
    - GSK Investigational Site
- North Carolina
  - Asheville, North Carolina, 미국, 28801
    - GSK Investigational Site
  - Durham, North Carolina, 미국, 27705
    - GSK Investigational Site
- Oklahoma
  - Tulsa, Oklahoma, 미국, 74104
    - GSK Investigational Site
- Oregon
  - Portland, Oregon, 미국, 97239
    - GSK Investigational Site
- Pennsylvania
  - Hershey, Pennsylvania, 미국, 17033-0850
    - GSK Investigational Site
  - Philadelphia, Pennsylvania, 미국, 19104
    - GSK Investigational Site
- Tennessee
  - Jackson, Tennessee, 미국, 38301
    - GSK Investigational Site
  - Nashville, Tennessee, 미국, 37212
    - GSK Investigational Site
  - Nashville, Tennessee, 미국, 37203
    - GSK Investigational Site
  - Nashville, Tennessee, 미국, 37205
    - GSK Investigational Site
- Texas
  - Galveston, Texas, 미국, 77555-0435
    - GSK Investigational Site
  - Houston, Texas, 미국, 77030
    - GSK Investigational Site
  - San Antonio, Texas, 미국, 78215
    - GSK Investigational Site
- Virginia
  - Charlottesville, Virginia, 미국, 22908
    - GSK Investigational Site
  - Fairfax, Virginia, 미국, 22031
    - GSK Investigational Site
  - Richmond, Virginia, 미국, 23249
    - GSK Investigational Site
벨기에
- - Bruxelles, 벨기에, 1200
    - GSK Investigational Site
  - Edegem, 벨기에, 2650
    - GSK Investigational Site
  - Gent, 벨기에, 9000
    - GSK Investigational Site
  - Leuven, 벨기에, 3000
    - GSK Investigational Site
브라질
- - São Paulo, 브라질, 04023900
    - GSK Investigational Site
- São Paulo
  - Campinas, São Paulo, 브라질, 13083-888
    - GSK Investigational Site
스페인
- - Barcelona, 스페인, 08025
    - GSK Investigational Site
  - Granada, 스페인, 18012
    - GSK Investigational Site
  - L'Hospitalet de Llobregat. Barcelona, 스페인, 08907
    - GSK Investigational Site
  - La Coruña, 스페인, 15006
    - GSK Investigational Site
  - Madrid, 스페인, 28006
    - GSK Investigational Site
  - Madrid, 스페인, 28007
    - GSK Investigational Site
  - Madrid, 스페인, 28034
    - GSK Investigational Site
  - Madrid, 스페인, 28029
    - GSK Investigational Site
  - San Sebastián, 스페인, 20014
    - GSK Investigational Site
  - Sevilla, 스페인, 41014
    - GSK Investigational Site
  - Valencia, 스페인, 46010
    - GSK Investigational Site
슬로바키아
- - Bratislava, 슬로바키아, 833 05
    - GSK Investigational Site
  - Bratislava, 슬로바키아, 811 07
    - GSK Investigational Site
  - Kosice, 슬로바키아, 041 66
    - GSK Investigational Site
  - Martin, 슬로바키아, 036 59
    - GSK Investigational Site
영국
- - London, 영국, NW3 2QG
    - GSK Investigational Site
  - London, 영국, W2 1NY
    - GSK Investigational Site
  - Plymouth, 영국, PL6 8DH
    - GSK Investigational Site
- Lanarkshire
  - Glasgow, Lanarkshire, 영국, G12 0YN
    - GSK Investigational Site
우크라이나
- - Donetsk, 우크라이나, 83114
    - GSK Investigational Site
  - Kyiv, 우크라이나, 04112
    - GSK Investigational Site
  - Kyiv, 우크라이나, 01030
    - GSK Investigational Site
  - Vinnytsia, 우크라이나, 21021
    - GSK Investigational Site
이스라엘
- - Haifa, 이스라엘, 31096
    - GSK Investigational Site
  - Jerusalem, 이스라엘, 91120
    - GSK Investigational Site
  - Petach Tikva, 이스라엘, 49100
    - GSK Investigational Site
  - Safed, 이스라엘, 13110
    - GSK Investigational Site
  - Tel Aviv, 이스라엘, 64239
    - GSK Investigational Site
이탈리아
- Calabria
  - Catanzaro, Calabria, 이탈리아, 88100
    - GSK Investigational Site
- Campania
  - Avellino, Campania, 이탈리아, 83100
    - GSK Investigational Site
- Emilia-Romagna
  - Bologna, Emilia-Romagna, 이탈리아, 40138
    - GSK Investigational Site
- Lazio
  - Roma, Lazio, 이탈리아, 00133
    - GSK Investigational Site
- Liguria
  - Genova, Liguria, 이탈리아, 16132
    - GSK Investigational Site
- Lombardia
  - Brescia, Lombardia, 이탈리아, 25123
    - GSK Investigational Site
  - Milano, Lombardia, 이탈리아, 20132
    - GSK Investigational Site
  - Milano, Lombardia, 이탈리아, 20157
    - GSK Investigational Site
- Puglia
  - Bari, Puglia, 이탈리아, 70124
    - GSK Investigational Site
  - San Giovanni Rotondo (FG), Puglia, 이탈리아, 71013
    - GSK Investigational Site
- Sicilia
  - Palermo, Sicilia, 이탈리아, 90127
    - GSK Investigational Site
인도
- - Bangalore, 인도
    - GSK Investigational Site
  - Chennai, 인도, 600 096
    - GSK Investigational Site
  - Mumbai, 인도, 400036
    - GSK Investigational Site
체코 공화국
- - Praha 4, 체코 공화국, 140 21
    - GSK Investigational Site
  - Praha 6, 체코 공화국, 169 02
    - GSK Investigational Site
캐나다
- Alberta
  - Calgary, Alberta, 캐나다, T2N 4Z6
    - GSK Investigational Site
- British Columbia
  - Victoria, British Columbia, 캐나다, V8V 3P9
    - GSK Investigational Site
- Manitoba
  - Winnipeg, Manitoba, 캐나다, R3E 3P4
    - GSK Investigational Site
- Ontario
  - Barrie, Ontario, 캐나다, L4M 7G1
    - GSK Investigational Site
  - Hamilton, Ontario, 캐나다, L8N 4A6
    - GSK Investigational Site
  - Hamilton, Ontario, 캐나다, L8L 2X2
    - GSK Investigational Site
  - Ottawa, Ontario, 캐나다, K1N 6N5
    - GSK Investigational Site
  - Ottawa, Ontario, 캐나다, K1H 8L6
    - GSK Investigational Site
  - Toronto, Ontario, 캐나다, M5T 2S8
    - GSK Investigational Site
  - Toronto, Ontario, 캐나다, M5G 1X5
    - GSK Investigational Site
  - Toronto, Ontario, 캐나다, M5G 2C4
    - GSK Investigational Site
  - Toronto, Ontario, 캐나다, M6H 3M1
    - GSK Investigational Site
- Quebec
  - Montreal, Quebec, 캐나다, H2X 2P4
    - GSK Investigational Site
  - Montreal, Quebec, 캐나다, H2X 3J4
    - GSK Investigational Site
태국
- - Bangkok, 태국, 10330
    - GSK Investigational Site
  - Bangkok, 태국, 10700
    - GSK Investigational Site
  - Chiangmai, 태국, 50200
    - GSK Investigational Site
  - Khon Kaen, 태국, 40002
    - GSK Investigational Site
  - Songkla, 태국, 90110
    - GSK Investigational Site
파키스탄
- - Lahore, 파키스탄, 54600
    - GSK Investigational Site
  - Lahore, 파키스탄, 54000
    - GSK Investigational Site
폴란드
- - Bydgoszcz, 폴란드, 85-030
    - GSK Investigational Site
  - Chorzow, 폴란드, 41-500
    - GSK Investigational Site
  - Kielce, 폴란드, 25-317
    - GSK Investigational Site
  - Szczecin, 폴란드, 71-455
    - GSK Investigational Site
  - Wroclaw, 폴란드, 51-149
    - GSK Investigational Site
푸에르토 리코
- - Ponce, 푸에르토 리코, 00717
    - GSK Investigational Site
  - San Juan, 푸에르토 리코, 00927
    - GSK Investigational Site
프랑스
- - Besançon, 프랑스, 25030
    - GSK Investigational Site
  - Dijon cedex, 프랑스, 21019
    - GSK Investigational Site
  - Marseille, 프랑스, 13385
    - GSK Investigational Site
  - Montpellier, 프랑스, 34295
    - GSK Investigational Site
  - Nice, 프랑스, 06202
    - GSK Investigational Site
  - Pessac Cedex, 프랑스, 33604
    - GSK Investigational Site
  - Strasbourg, 프랑스, 67091
    - GSK Investigational Site
  - Toulouse, 프랑스, 31300
    - GSK Investigational Site
  - Toulouse cedex 9, 프랑스, 31059
    - GSK Investigational Site
호주
- Australian Capital Territory
  - Garran, Australian Capital Territory, 호주, 2606
    - GSK Investigational Site
- New South Wales
  - Camperdown, New South Wales, 호주, 2050
    - GSK Investigational Site
  - Randwick, New South Wales, 호주, 2031
    - GSK Investigational Site
- Victoria
  - Fitzroy, Victoria, 호주, 3065
    - GSK Investigational Site
  - Heidelberg, Victoria, 호주, 3084
    - GSK Investigational Site
  - Melbourne, Victoria, 호주, 3168
    - GSK Investigational Site
- Western Australia
  - Nedlands, Western Australia, 호주, 6009
    - GSK Investigational Site
홍콩
- - Pokfulam, 홍콩
    - GSK Investigational Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

Male and female subjects, >18 years Evidence of chronic hepatitis C virus (HCV) infection Subjects who are appropriate candidates for peginterferon (pegIFN) and ribavirin antiviral therapy A platelet count of <75,000/mcL Haemoglobin >11.0g/dL for men or >10.0g/dL for women Absolute neutrophil count (ANC) >750/mm3 and no history of infections associated with neutropenia Creatinine clearance >50mL/minute All fertile males and females must use two forms of effective contraception between them during treatment and during the 24 weeks after treatment end Subject is able to understand, consent and comply with protocol requirements and instructions and is likely to complete the study as planned

Exclusion criteria:

Non-responders to previous treatment with pegIFN and ribavirin who failed to achieve a sustained virologic response (SVR) for reasons other than thrombocytopenia, despite an optimal course (dose and duration) of combination therapy with pegIFN and ribavirin Decompensated liver disease, e.g. Child-Pugh score >6 or history of ascites or hepatic encephalopathy or current evidence of ascites Known hypersensitivity, intolerance or allergy to interferon (IFN), ribavirin, eltrombopag or any of their ingredients Serious cardiac, cerebrovascular, or pulmonary disease that would preclude treatment with pegIFN and ribavirin

Subjects with a history of any one of the following:

Suicide attempt or hospitalisation for depression in the past 5 years Any current severe or poorly controlled psychiatric disorder

The following subjects are eligible for study participation, but must be assessed and followed (if recommended) by a mental health professional:

Subjects who have had a severe or poorly controlled psychiatric disorder more than 6 months ago but less than 5 years ago
Seizure disorder that has not been well controlled History of clinically significant bleeding from oesophageal or gastric varices Subjects with haemoglobinopathies, e.g. sickle cell anaemia, thalassemia major Any prior history of arterial or venous thrombosis AND two or more of the following risk factors: hereditary thrombophilic disorders (e.g. Factor V Leiden, antithrombin III (ATIII) deficiency, etc), hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension or cancer Pre-existing cardiac disease (New York Heart Association (NYHA) Grade III/IV), or arrhythmias known to involve the risk of thromboembolic events, or corrected QT interval (QTc) >450 msec Evidence of hepatocellular carcinoma Laboratory evidence of infection with human immunodeficiency virus (HIV) or active Hepatitis B Virus (HBV) infection Any disease condition associated with active bleeding or requiring anticoagulation with heparin or warfarin Therapy with any anti-neoplastic or immuno-modulatory treatment <6 months prior to the first dose of eltrombopag Subjects who have had a malignancy diagnosed and/or treated within the past 5 years, except for subjects with localised basal or squamous cell carcinoma treated by local excision or subjects with malignancies who have been adequately treated and, in the opinion of the oncologist, have an excellent chance of cancer-free survival Pregnant or nursing women Males with a female partner who is pregnant History of alcohol/drug abuse or dependence within 6 months of the study start (unless participating in a controlled rehabilitation programme) Treatment with an investigational drug or IFN within 30 days or 5 half-lives (whichever is longer) of the screening visit History of platelet clumping that prevents reliable measurement of platelet counts History of major organ transplantation with an existing functional graft Thyroid dysfunction not adequately controlled Subjects planning to have cataract surgery Evidence of portal vein thrombosis on abdominal imaging within 3 months of the baseline visit

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위
중재 모델: 병렬 할당
마스킹: 네 배로

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase 기간: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)	Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the treatment period of the DB Phase.	From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

2차 결과 측정

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

GlaxoSmithKline

간행물 및 유용한 링크

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

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2007년 10월 1일

기본 완료 (실제)

2011년 4월 1일

연구 완료 (실제)

2011년 5월 1일

연구 등록 날짜

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2007년 8월 13일

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2007년 8월 13일

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2007년 8월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 11월 5일

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2013년 10월 10일

마지막으로 확인됨

2012년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

TPL103922

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만성 C형 간염에 대한 임상 시험

Hospital Clinic of Barcelona
AstraZeneca

완전한

TIcaGrEloR 및 ABSORB 생체흡수성 혈관 스캐폴드 이식으로 성공적인 만성 전폐쇄 재개통술 후 혈관 기능 회복 (TIGER-BVS)

CTO(Chronic Total Occlusion)를 위한 PCI(Percutaneous Coronary Intervention)를 받을 예정인 환자

스페인
University College Cork
Dupont Applied Biosciences

모병

제왕절개로 태어난 영아의 미생물 누락 (MiMIC)

C 섹션

아일랜드
Meir Medical Center

완전한

시신경유두의 디지털 스테레오 이미지의 C/D 비율을 측정하는 재현 가능한 새로운 방법

디지털 스테레오 광 디스크 이미지에서 C/D 비율을 측정하는 새로운 기술 개발 | C/D 측정의 관찰자 내 재현성 | C/D 측정의 관찰자 간 가변성
University Hospital, Grenoble
Clinical Investigation Centre for Innovative Technology Network

완전한

기존 외과 진료에서 C-ARM ARCO FP-Rk521 S 평가

C. 수술 절차

프랑스
National Taiwan University Hospital

완전한

산부인과 환자에서 척추마취 정도와 복부둘레 및 체간 길이의 관계

C/S 산부인과

대만
Haisco Pharmaceutical Group Co., Ltd.

완전한

건강한 피험자와 LDL-C가 상승한 피험자에서 HSK31679를 평가하기 위한 단일 용량 및 다중 용량 상승 연구

건강한 | 상승된 LDL-C

중국
Cairo University

완전한

초음파 강화 봉독이 선택된 서혜부 탈장술 후 합병증에 미치는 영향

합병증; C, 장(내장)

이집트
University Hospital, Caen

완전한

Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA) (EMOA)

C. 수술 절차; 심장병 환자

프랑스
University of Sao Paulo General Hospital
InCor Heart Institute; Chinese Academy of Medical Sciences, Fuwai Hospital; Beneficência... 그리고 다른 협력자들

알려지지 않은

심장 수술 절차의 고위험 환자: HiriSCORE (HiriSCORE)

C. 수술 절차; 심장병 환자

브라질
Hongwen Ji

완전한

심장 수술에서 Tranexamic Acid의 전향적 시도

C. 수술 절차; 심장병 환자

중국

eltrombopag에 대한 임상 시험

GlaxoSmithKline

완전한

2상, 만성 간질환을 앓고 있는 일본 혈소판감소증 환자에서 엘트롬보팍의 약동학 연구

간 질환

일본
University Children's Hospital Basel
Novartis Pharmaceuticals; Stiftung zur Förderung medizinischer und biologischer Forschung; University of Erlangen-Nürnberg, Department of Biology

모집하지 않고 적극적으로

ITP에서 Eltrombopag를 사용한 면역 조절 (iROM2)

원발성 면역 혈소판 감소증(ITP)

스위스
The First Affiliated Hospital of Soochow University

모병

BMFS에서 Eltrombopag Post HSCT의 사용

줄기 세포 이식 합병증

중국
Safaa AA Khaled
Assiut University

완전한

재생불량성 빈혈에서 트롬보포이에틴 모방제와 면역억제제 병용 요법

재생 불량성 빈혈

이집트

결과 측정	측정값 설명	기간
OL 단계 동안 표시된 시점에서 중간 혈소판 수 기간: OL 단계: 기준선; 1일; 1, 2, 3, 4, 5, 6, 7, 8 및 9주; 항바이러스 베이스라인(10주차까지); 치료 종료(48주차까지); 4주 후속 조치(FU)(최대 62주차); 12주 FU(최대 70주); 및 24주 FU(최대 82주차)	혈소판 측정에는 말초혈관에서 채취한 혈액을 사용하였다. Last On Treatment 평가는 조사자가 입력한 End of Treatment 평가가 아니라 실제 마지막 치료 평가를 의미합니다.	OL 단계: 기준선; 1일; 1, 2, 3, 4, 5, 6, 7, 8 및 9주; 항바이러스 베이스라인(10주차까지); 치료 종료(48주차까지); 4주 후속 조치(FU)(최대 62주차); 12주 FU(최대 70주); 및 24주 FU(최대 82주차)
DB 단계에서 페그인터페론 알파-2a 및 리바비린 요법의 초회 용량 감소까지의 시간 기간: 기준선부터 48주차 또는 72주차(유전자형 2/3형 참가자의 경우) 또는 72주차(비유전자형 2/3형 참가자의 경우)까지	첫 번째 용량 감소까지의 시간은 첫 번째 용량부터 첫 번째 용량 감소까지의 기간으로 계산되었습니다.	기준선부터 48주차 또는 72주차(유전자형 2/3형 참가자의 경우) 또는 72주차(비유전자형 2/3형 참가자의 경우)까지
DB 단계 동안 표시된 시점에서 수축기 혈압(SBP) 및 이완기 혈압(DBP)의 기준선으로부터의 평균 변화 기간: DB 단계: 기준선; 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 및 44주; 치료 종료(48주차까지); 4주 후속 조치(FU)(최대 52주차); 12주 FU(최대 60주차); 및 24주 FU(최대 72주차)	참가자의 혈압은 연구 중 표시된 시점에서 측정되었습니다. 수축기 혈압은 심장이 뛰는 동안의 혈압을 측정한 것입니다. 이완기 혈압은 심장이 이완되어 있을 때의 혈압을 측정한 것입니다. 기준선으로부터의 평균 변화는 표시된 시점의 값에서 기준선의 값을 뺀 값으로 계산되었습니다.	DB 단계: 기준선; 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 및 44주; 치료 종료(48주차까지); 4주 후속 조치(FU)(최대 52주차); 12주 FU(최대 60주차); 및 24주 FU(최대 72주차)
DB 단계 동안 표시된 시점에서 심박수의 기준선으로부터의 평균 변화 기간: DB 단계: 기준선; 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 및 44주; 치료 종료(48주차까지); 4주 후속 조치(FU)(최대 52주차); 12주 FU(최대 60주차); 및 24주 FU(최대 72주차)	표시된 시점에서 참가자의 심박수를 측정했습니다. 기준선으로부터의 평균 변화는 표시된 시점의 값에서 기준선의 값을 뺀 값으로 계산되었습니다.	DB 단계: 기준선; 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 및 44주; 치료 종료(48주차까지); 4주 후속 조치(FU)(최대 52주차); 12주 FU(최대 60주차); 및 24주 FU(최대 72주차)
DB 단계 동안 표시된 시점에서 무게의 기준선으로부터의 평균 변화 기간: DB 단계: 기준선; 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 및 44주; 치료 종료(48주차까지); 4주 후속 조치(FU)(최대 52주차); 12주 FU(최대 60주차); 및 24주 FU(최대 72주차)	참가자의 체중은 표시된 시점에 기록되었습니다. 기준선으로부터의 평균 변화는 표시된 시점의 값에서 기준선의 값을 뺀 값으로 계산되었습니다.	DB 단계: 기준선; 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 및 44주; 치료 종료(48주차까지); 4주 후속 조치(FU)(최대 52주차); 12주 FU(최대 60주차); 및 24주 FU(최대 72주차)
DB 단계 동안 표시된 시점에서 체질량 지수(BMI)의 기준선으로부터의 평균 변화 기간: DB 단계: 기준선; 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 및 44주; 치료 종료(48주차까지); 4주 후속 조치(FU)(최대 52주차); 12주 FU(최대 60주차); 및 24주 FU(최대 72주차)	참가자의 BMI는 표시된 시점에서 체중(킬로그램)을 키의 제곱으로 나눈 값으로 계산되었습니다. 기준선으로부터의 평균 변화는 표시된 시점의 값에서 기준선의 값을 뺀 값으로 계산되었습니다.	DB 단계: 기준선; 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 및 44주; 치료 종료(48주차까지); 4주 후속 조치(FU)(최대 52주차); 12주 FU(최대 60주차); 및 24주 FU(최대 72주차)
Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 90 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase 기간: From Baseline up to Week 9 in the OL Phase	Participants were assessed for a shift from a baseline platelet count of <75 Gi/L to a count >=90 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw.	From Baseline up to Week 9 in the OL Phase
Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase 기간: From Baseline up to Week 9 in the OL Phase	In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was <90 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained <90 Gi/L. Participants who achieved platelet count >=90 Gi/L on any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase.	From Baseline up to Week 9 in the OL Phase
Median Platelet Count at the Indicated Time Points During the DB Phase 기간: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)	Blood taken from peripheral blood vessels was used for the measurement of platelet counts.	DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy During the DB Phase 기간: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)	The minimum platelet count with antiviral therapy was categorized as follows: <25 Gi/L; >=25 to <50 Gi/L; >=50 to <90 Gi/L; >=90 to <150 Gi/L; >=150 Gi/L to <200 Gi/L; >=200 Gi/L to <400 Gi/L; and >=400 Gi/L.	From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase 기간: From Baseline up to Week 12	RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12.	From Baseline up to Week 12
Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase 기간: From Baseline up to Week 12	EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment.	From Baseline up to Week 12
Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase 기간: From Baseline up to Week 36 or Week 60 (for participants with Genotype 2/3) or up to Week 60 (for participants with Non-Genotype 2/3)	ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment.	From Baseline up to Week 36 or Week 60 (for participants with Genotype 2/3) or up to Week 60 (for participants with Non-Genotype 2/3)
Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase 기간: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)	Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin.	From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase 기간: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)	The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (mcg). For peginterferon dose modification, downward adjustments in one level increments was considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 mcg. Where dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 mcg was generally adequate. In some cases, a dose reduction to 90 mcg or 45mcg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved.	From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase 기간: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)	The following participants were considered to have discontinued from antiviral therapy: participants who were lost to follow-up; participants who withdrew for any reason; participants who died; participants who otherwise did not complete their planned course of antiviral therapy for any reason. The planned duration of antiviral therapy was 48 weeks for participants with Non-Genotype 2/3 and 24 or 48 weeks for participants with Genotype 2/3.	From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Number of Participants (Par.) Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) During the DB Phase 기간: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)	There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. Genotyping of the IL28B polymorphisms (rs12979860 and rs8099917) was conducted. IL28B genotype distribution by response to antiviral therapy (SVR and RVR) for both treatment arms was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.	From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Number of Par. With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) During the DB Phase 기간: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)	Blood samples for the assessment of clinical chemistry parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.	From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS During the DB Phase 기간: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)	Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.	From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication During the DB Phase 기간: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)	Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral.	From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase 기간: DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)	Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The investigator assigned an ECG status of normal, abnormal, CS, or NCS; a status of "abnormal" alone indicates that the investigator did not determine if ECG was CS or NCS. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.	DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)
Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase 기간: End of Treatment (up to Week 52); and 24-week FU (up to Week 72)	Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS or a NCS change from baseline in ECG status was reported, as determined by the Investigator based on a reasonable standard of clinical judgment. "Not applicable" indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS.	End of Treatment (up to Week 52); and 24-week FU (up to Week 72)