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

2013年10月10日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

27

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • California
      • San Diego、California、アメリカ、92123
        • GSK Investigational Site
    • Connecticut
      • New Haven、Connecticut、アメリカ、06520
        • GSK Investigational Site
    • Hawaii
      • Honolulu、Hawaii、アメリカ、96817
        • GSK Investigational Site
    • New York
      • Manhasset、New York、アメリカ、11030
        • GSK Investigational Site
    • Tennessee
      • Nashville、Tennessee、アメリカ、37212
        • GSK Investigational Site
    • Washington
      • Seattle、Washington、アメリカ、98111
        • GSK Investigational Site
  • イタリア
    • Emilia-Romagna
      • Bologna、Emilia-Romagna、イタリア、40138
        • GSK Investigational Site
    • Liguria
      • Genova、Liguria、イタリア、16132
        • GSK Investigational Site
    • Lombardia
      • Milano、Lombardia、イタリア、20157
        • GSK Investigational Site
  • オーストラリア
    • New South Wales
      • Camperdown、New South Wales、オーストラリア、2050
        • GSK Investigational Site
      • Randwick、New South Wales、オーストラリア、2031
        • GSK Investigational Site
    • Queensland
      • Herston、Queensland、オーストラリア、4029
        • GSK Investigational Site
  • カナダ
    • Ontario
      • Toronto、Ontario、カナダ、M5G 2N2
        • GSK Investigational Site
    • Quebec
      • Montreal、Quebec、カナダ、H2X 3J4
        • GSK Investigational Site
  • ギリシャ
      • Athens、ギリシャ、10676
        • GSK Investigational Site
  • スペイン
      • La Coruña、スペイン、15006
        • GSK Investigational Site
      • Madrid、スペイン、28029
        • GSK Investigational Site
      • Pontevedra、スペイン、36071
        • GSK Investigational Site
      • Valencia、スペイン、46010
        • GSK Investigational Site
  • ドイツ
      • Berlin、ドイツ、10969
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Freiburg、Baden-Wuerttemberg、ドイツ、79106
        • GSK Investigational Site
      • Ulm、Baden-Wuerttemberg、ドイツ、89081
        • GSK Investigational Site
    • Bayern
      • Muenchen、Bayern、ドイツ、81675
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Duesseldorf、Nordrhein-Westfalen、ドイツ、40225
        • GSK Investigational Site
  • パキスタン
      • Lahore、パキスタン、54600
        • GSK Investigational Site
  • フランス
      • Marseille Cedex 08、フランス、13285
        • GSK Investigational Site
      • Nice cedex 3、フランス、06202
        • GSK Investigational Site
      • Pessac Cedex、フランス、33604
        • GSK Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：非ランダム化
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Open-label eltrombopag
Open-label eltrombopag with dose titrations to support adequate platelet counts.
薬：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.
他の名前：
  • プロマクタ
薬：Antiviral therapy
Combination of either peginterferon alfa-2a or alfa-2b with ribavirin at investigator's discretion.

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
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Platelet Counts at the Indicated Time Points
時間枠：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
時間枠：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)
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

GlaxoSmithKline

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2009年9月1日

一次修了 (実際)

2013年2月1日

研究の完了 (実際)

2013年2月1日

試験登録日

最初に提出

2009年10月1日

QC基準を満たした最初の提出物

2009年10月15日

最初の投稿 (見積もり)

2009年10月16日

学習記録の更新

投稿された最後の更新 (見積もり)

2013年12月6日

QC基準を満たした最後の更新が送信されました

2013年10月10日

最終確認日

2013年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 108392

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。

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