이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Clinical Trial for Non-responders Who Previously Participated in Eltrombopag Studies TPL 103922 or TPL 108390 (ENABLE-ALL)

2013년 10월 10일 업데이트: GlaxoSmithKline

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

The purpose of this study is to test the safety and tolerability of eltrombopag when used to increase and maintain platelet count. Platelet count to be maintained at a level sufficient to facilitate initiation of antiviral therapy, to minimize antiviral therapy dose reductions, and to avoid permanent discontinuation of antiviral therapy.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

27

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 그리스
      • Athens, 그리스, 10676
        • GSK Investigational Site
  • 독일
      • Berlin, 독일, 10969
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Freiburg, Baden-Wuerttemberg, 독일, 79106
        • GSK Investigational Site
      • Ulm, Baden-Wuerttemberg, 독일, 89081
        • GSK Investigational Site
    • Bayern
      • Muenchen, Bayern, 독일, 81675
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Duesseldorf, Nordrhein-Westfalen, 독일, 40225
        • GSK Investigational Site
  • 미국
    • California
      • San Diego, California, 미국, 92123
        • GSK Investigational Site
    • Connecticut
      • New Haven, Connecticut, 미국, 06520
        • GSK Investigational Site
    • Hawaii
      • Honolulu, Hawaii, 미국, 96817
        • GSK Investigational Site
    • New York
      • Manhasset, New York, 미국, 11030
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, 미국, 37212
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, 미국, 98111
        • GSK Investigational Site
  • 스페인
      • La Coruña, 스페인, 15006
        • GSK Investigational Site
      • Madrid, 스페인, 28029
        • GSK Investigational Site
      • Pontevedra, 스페인, 36071
        • GSK Investigational Site
      • Valencia, 스페인, 46010
        • GSK Investigational Site
  • 이탈리아
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, 이탈리아, 40138
        • GSK Investigational Site
    • Liguria
      • Genova, Liguria, 이탈리아, 16132
        • GSK Investigational Site
    • Lombardia
      • Milano, Lombardia, 이탈리아, 20157
        • GSK Investigational Site
  • 캐나다
    • Ontario
      • Toronto, Ontario, 캐나다, M5G 2N2
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, 캐나다, H2X 3J4
        • GSK Investigational Site
  • 파키스탄
      • Lahore, 파키스탄, 54600
        • GSK Investigational Site
  • 프랑스
      • Marseille Cedex 08, 프랑스, 13285
        • GSK Investigational Site
      • Nice cedex 3, 프랑스, 06202
        • GSK Investigational Site
      • Pessac Cedex, 프랑스, 33604
        • GSK Investigational Site
  • 호주
    • New South Wales
      • Camperdown, New South Wales, 호주, 2050
        • GSK Investigational Site
      • Randwick, New South Wales, 호주, 2031
        • GSK Investigational Site
    • Queensland
      • Herston, Queensland, 호주, 4029
        • 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:

  • Prior participation in protocol TPL103922 or TPL108390 and completed the Week 24 Follow Up Visit in TPL103922 or TPL108390
  • Male or female ≥18 years old
  • Evidence of chronic HCV infection
  • While participating in TPL103922 or TPL108390, discontinued from study drug due to thrombocytopenia
  • Appropriate candidate for antiviral therapy with pegylated interferon plus ribavirin
  • Platelet count <75,000
  • Fertile males and females must use two forms of effective contraception during treatment and for 24 weeks after treatment
  • Ability to understand and comply with the protocol requirements and instructions
  • Ability to provide written informed consent

Exclusion Criteria:

  • Decompensated liver disease
  • Known hypersensitivity, intolerance, or allergy to interferon, ribavirin, eltrombopag, or their ingredients
  • History of clinically significant bleeding from oesophageal or gastric varices
  • History of arterial or venous thrombosis and two or more of the following risk factors: hereditary thrombophilic disorders; hormone replacement therapy; systemic contraception (containing estrogen); smoking; diabetes; hypercholesterolemia; medication for hypertension or cancer
  • Pre-existing cardiac disease (congestive heart failure Grade III/IV) or arrhythmias known to involve the risk of thromboembolic events (e.g. atrial fibrillation)
  • Evidence of hepatocellular carcinoma
  • HIV or Hepatitis B infection
  • Therapy with anti-neoplastic or immunomodulatory treatment within six months prior to eltrombopag therapy
  • Malignancy diagnosed or treated within the past five years. Except for localized basal or squamous cell carcinoma treated by local excision or malignancies that were adequately treated and, in the opinion of the oncologist, have an excellent chance of cancer-free survival.
  • Pregnant or nursing women
  • Men with a female partner who is pregnant
  • History of alcohol/drug abuse or dependence within six months of the study start unless participating in a controlled rehabilitation programme.
  • Treatment with an investigational drug or interferon within 30 days or 5 half-lives (whichever is longer) of the screening visit
  • History or platelet clumping that prevents reliable measurement of platelet counts
  • Evidence of portal vein thrombosis within three months of 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: 무작위화되지 않음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Open-label eltrombopag
Open-label eltrombopag with dose titrations to support adequate platelet counts.
의약품: Eltrombopag
Eltrombopag starting at 25 mg dose and titrated in Part 1 of study to 50, 75, 100 mg. Platelet count must reach sufficient level to allow initiation of antiviral therapy. Eltrombopag dose may be adjusted during antiviral treatment phase of study to maintain platelet count to continue antiviral therapy without adjustment to antiviral dose.
다른 이름들:
  • 프로막타
의약품: Antiviral therapy
Combination of either peginterferon alfa-2a or alfa-2b with ribavirin at investigator's discretion.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1
기간: From the start of investigational product up to the start of antiviral therapy (up to 9 weeks; median of 21 days)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.
From the start of investigational product up to the start of antiviral therapy (up to 9 weeks; median of 21 days)
Number of Participants With Any AE and Any SAE in Part 2
기간: From the date of initiation of antiviral therapy (Antiviral Baseline Visit [between Study Day 14 and Study Day 65]) to the completion of the follow-up period (up to Week 96/WD)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.
From the date of initiation of antiviral therapy (Antiviral Baseline Visit [between Study Day 14 and Study Day 65]) to the completion of the follow-up period (up to Week 96/WD)
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1
기간: From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)
Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.
From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2
기간: From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)
Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.
From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1
기간: From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)
Blood samples were collected for the measurement of hematology parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.
From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2
기간: From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)
Blood samples were collected for the measurement of hematology chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.
From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)
Number of Participants With a Decrease in Visual Acuity During Parts 1 and 2
기간: From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)
Visual acuity (VA) is defined as acuteness or clearness of vision.
From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)
Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2
기간: From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)
LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.
From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)
Number of Participants With a logMAR Change >=0.15 During Parts 1 and 2
기간: From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)
LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.
From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

2차 결과 측정

결과 측정
측정값 설명
기간
Platelet Counts at the Indicated Time Points
기간: From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)
Blood samples were collected for the measurement of platelet count. For each participant, the duration of Part 1 treatment varies between 2 and 9 weeks.
From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)
Number of Particpants Who Initiated Antiviral Therapy
기간: From the start of the investigational product up to 9 weeks (median of 21 days)
The number of participants who completed the Pre-antiviral Phase (Part 1) and proceeded to the Antiviral Phase (Part 2) are summarized.
From the start of the investigational product up to 9 weeks (median of 21 days)
Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR)
기간: From the start of investigational product in Part 2 up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)
SVR is defined as non-detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the planned treatment period (i.e., Week 48 or 72 for genotype 2/3 or Week 72 for non-genotype 2/3). RVR is defined as undetectable HCV RNA after 4 weeks of antiviral treatment. EVR is defined as clinically significant reduction in HCV RNA (>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. ETR is defined as undetectable HCV RNA at the end of antiviral treatment.
From the start of investigational product in Part 2 up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

GlaxoSmithKline

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

2009년 9월 1일

기본 완료 (실제)

2013년 2월 1일

연구 완료 (실제)

2013년 2월 1일

연구 등록 날짜

최초 제출

2009년 10월 1일

QC 기준을 충족하는 최초 제출

2009년 10월 15일

처음 게시됨 (추정)

2009년 10월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 12월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 10월 10일

마지막으로 확인됨

2013년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 108392

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. .

C 형 간염에 대한 임상 시험

Eltrombopag에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Bulgaria

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다