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

10. Oktober 2013 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

27

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Open-label eltrombopag
Open-label eltrombopag with dose titrations to support adequate platelet counts.
Arzneimittel: 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.
Andere Namen:
  • Promacta
Arzneimittel: Antiviral therapy
Combination of either peginterferon alfa-2a or alfa-2b with ribavirin at investigator's discretion.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Platelet Counts at the Indicated Time Points
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

GlaxoSmithKline

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2009

Primärer Abschluss (Tatsächlich)

1. Februar 2013

Studienabschluss (Tatsächlich)

1. Februar 2013

Studienanmeldedaten

Zuerst eingereicht

1. Oktober 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Oktober 2009

Zuerst gepostet (Schätzen)

16. Oktober 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

6. Dezember 2013

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Oktober 2013

Zuletzt verifiziert

1. August 2013

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 108392

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