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

10. Oktober 2013 aktualisiert von: 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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

687

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

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

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mittlere Thrombozytenzahl zu den angegebenen Zeitpunkten während der OL-Phase
Zeitfenster: OL-Phase: Baseline; Tag 1; Wochen 1, 2, 3, 4, 5, 6, 7, 8 und 9; Antiviraler Ausgangswert (bis Woche 10); Ende der Behandlung (bis Woche 48); 4-wöchiges Follow-up (FU) (bis Woche 62); 12-wöchige FU (bis Woche 70); und 24-wöchiges FU (bis Woche 82)
Zur Messung der Thrombozytenzahl wurde Blut aus peripheren Blutgefäßen verwendet. Die Beurteilung „Letzte Behandlung“ bezieht sich auf die tatsächliche Beurteilung der letzten Behandlung, nicht unbedingt auf die vom Prüfer eingegebene Beurteilung „Ende der Behandlung“.
OL-Phase: Baseline; Tag 1; Wochen 1, 2, 3, 4, 5, 6, 7, 8 und 9; Antiviraler Ausgangswert (bis Woche 10); Ende der Behandlung (bis Woche 48); 4-wöchiges Follow-up (FU) (bis Woche 62); 12-wöchige FU (bis Woche 70); und 24-wöchiges FU (bis Woche 82)
Zeit bis zur ersten Dosisreduktion der Peginterferon Alfa-2a- und Ribavirin-Therapie in der DB-Phase
Zeitfenster: Vom Ausgangswert bis Woche 48 oder Woche 72 (für Teilnehmer mit Genotyp 2/3) oder bis Woche 72 (für Teilnehmer mit Nicht-Genotyp 2/3)
Die Zeit bis zur ersten Dosisreduktion wurde als der Zeitraum von der ersten Dosis bis zur ersten Dosisreduktion berechnet.
Vom Ausgangswert bis Woche 48 oder Woche 72 (für Teilnehmer mit Genotyp 2/3) oder bis Woche 72 (für Teilnehmer mit Nicht-Genotyp 2/3)
Mittlere Änderung des systolischen Blutdrucks (SBP) und des diastolischen Blutdrucks (DBP) gegenüber dem Ausgangswert zu den angegebenen Zeitpunkten während der DB-Phase
Zeitfenster: DB-Phase: Baseline; Wochen 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 und 44; Ende der Behandlung (bis Woche 48); 4-wöchiges Follow-up (FU) (bis Woche 52); 12-wöchige FU (bis Woche 60); und 24-wöchiges FU (bis Woche 72)
Der Blutdruck des Teilnehmers wurde zu den angegebenen Zeitpunkten während der Studie gemessen. Der systolische Blutdruck ist ein Maß für den Blutdruck, während das Herz schlägt. Der diastolische Blutdruck ist ein Maß für den Blutdruck bei entspanntem Herzen. Die mittlere Änderung gegenüber dem Ausgangswert wurde als Wert zu den angegebenen Zeitpunkten minus dem Wert zum Ausgangswert berechnet.
DB-Phase: Baseline; Wochen 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 und 44; Ende der Behandlung (bis Woche 48); 4-wöchiges Follow-up (FU) (bis Woche 52); 12-wöchige FU (bis Woche 60); und 24-wöchiges FU (bis Woche 72)
Mittlere Änderung der Herzfrequenz gegenüber dem Ausgangswert zu den angegebenen Zeitpunkten während der DB-Phase
Zeitfenster: DB-Phase: Baseline; Wochen 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 und 44; Ende der Behandlung (bis Woche 48); 4-wöchiges Follow-up (FU) (bis Woche 52); 12-wöchige FU (bis Woche 60); und 24-wöchiges FU (bis Woche 72)
Die Herzfrequenz wurde bei den Teilnehmern zu den angegebenen Zeitpunkten gemessen. Die mittlere Änderung gegenüber dem Ausgangswert wurde als Wert zu den angegebenen Zeitpunkten minus dem Wert zum Ausgangswert berechnet.
DB-Phase: Baseline; Wochen 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 und 44; Ende der Behandlung (bis Woche 48); 4-wöchiges Follow-up (FU) (bis Woche 52); 12-wöchige FU (bis Woche 60); und 24-wöchiges FU (bis Woche 72)
Mittlere Gewichtsveränderung gegenüber dem Ausgangswert zu den angegebenen Zeitpunkten während der DB-Phase
Zeitfenster: DB-Phase: Baseline; Wochen 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 und 44; Ende der Behandlung (bis Woche 48); 4-wöchiges Follow-up (FU) (bis Woche 52); 12-wöchige FU (bis Woche 60); und 24-wöchiges FU (bis Woche 72)
Das Gewicht der Teilnehmer wurde zu den angegebenen Zeitpunkten aufgezeichnet. Die mittlere Änderung gegenüber dem Ausgangswert wurde als Wert zu den angegebenen Zeitpunkten minus dem Wert zum Ausgangswert berechnet.
DB-Phase: Baseline; Wochen 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 und 44; Ende der Behandlung (bis Woche 48); 4-wöchiges Follow-up (FU) (bis Woche 52); 12-wöchige FU (bis Woche 60); und 24-wöchiges FU (bis Woche 72)
Mittlere Änderung des Body-Mass-Index (BMI) gegenüber dem Ausgangswert zu den angegebenen Zeitpunkten während der DB-Phase
Zeitfenster: DB-Phase: Baseline; Wochen 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 und 44; Ende der Behandlung (bis Woche 48); 4-wöchiges Follow-up (FU) (bis Woche 52); 12-wöchige FU (bis Woche 60); und 24-wöchiges FU (bis Woche 72)
Der BMI der Teilnehmer wurde zu den angegebenen Zeitpunkten als Körpergewicht in Kilogramm geteilt durch Körpergröße in Metern zum Quadrat berechnet. Die mittlere Änderung gegenüber dem Ausgangswert wurde als Wert zu den angegebenen Zeitpunkten minus dem Wert zum Ausgangswert berechnet.
DB-Phase: Baseline; Wochen 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 und 44; Ende der Behandlung (bis Woche 48); 4-wöchiges Follow-up (FU) (bis Woche 52); 12-wöchige FU (bis Woche 60); und 24-wöchiges FU (bis Woche 72)
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

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Studienaufzeichnungsdaten

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Haupttermine studieren

Studienbeginn

1. Oktober 2007

Primärer Abschluss (Tatsächlich)

1. April 2011

Studienabschluss (Tatsächlich)

1. Mai 2011

Studienanmeldedaten

Zuerst eingereicht

13. August 2007

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. August 2007

Zuerst gepostet (Schätzen)

15. August 2007

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

5. November 2013

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Oktober 2013

Zuletzt verifiziert

1. August 2012

Mehr Informationen

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Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • TPL103922

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