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

10 de octubre de 2013 actualizado por: 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).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

687

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Recuento medio de plaquetas en los puntos de tiempo indicados durante la fase OL
Periodo de tiempo: Fase OL: Línea base; Día 1; Semanas 1, 2, 3, 4, 5, 6, 7, 8 y 9; Línea de base antiviral (hasta la semana 10); Fin del Tratamiento (hasta la Semana 48); seguimiento de 4 semanas (FU) (hasta la semana 62); FU de 12 semanas (hasta la semana 70); y FU de 24 semanas (hasta la semana 82)
La sangre extraída de los vasos sanguíneos periféricos se usó para la medición de los recuentos de plaquetas. La evaluación del último tratamiento se refiere a la evaluación del último tratamiento real, no necesariamente a la evaluación del final del tratamiento ingresada por el investigador.
Fase OL: Línea base; Día 1; Semanas 1, 2, 3, 4, 5, 6, 7, 8 y 9; Línea de base antiviral (hasta la semana 10); Fin del Tratamiento (hasta la Semana 48); seguimiento de 4 semanas (FU) (hasta la semana 62); FU de 12 semanas (hasta la semana 70); y FU de 24 semanas (hasta la semana 82)
Tiempo hasta la reducción de la primera dosis de terapia con peginterferón alfa-2a y ribavirina en la fase DB
Periodo de tiempo: Desde el inicio hasta la semana 48 o la semana 72 (para participantes con genotipo 2/3) o hasta la semana 72 (para participantes sin genotipo 2/3)
El tiempo hasta la primera reducción de dosis se calculó como el período de tiempo desde la primera dosis hasta la primera reducción de dosis.
Desde el inicio hasta la semana 48 o la semana 72 (para participantes con genotipo 2/3) o hasta la semana 72 (para participantes sin genotipo 2/3)
Cambio medio desde el inicio en la presión arterial sistólica (PAS) y la presión arterial diastólica (PAD) en los puntos de tiempo indicados durante la fase DB
Periodo de tiempo: Fase DB: Línea de base; Semanas 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 y 44; Fin del Tratamiento (hasta la Semana 48); seguimiento de 4 semanas (FU) (hasta la semana 52); FU de 12 semanas (hasta la semana 60); y FU de 24 semanas (hasta la semana 72)
La presión arterial del participante se midió en los puntos de tiempo indicados durante el estudio. La presión arterial sistólica es una medida de la presión arterial mientras el corazón late. La presión arterial diastólica es una medida de la presión arterial mientras el corazón está relajado. El cambio medio desde la línea de base se calculó como el valor en los puntos de tiempo indicados menos el valor en la línea de base.
Fase DB: Línea de base; Semanas 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 y 44; Fin del Tratamiento (hasta la Semana 48); seguimiento de 4 semanas (FU) (hasta la semana 52); FU de 12 semanas (hasta la semana 60); y FU de 24 semanas (hasta la semana 72)
Cambio medio desde el inicio en la frecuencia cardíaca en los puntos de tiempo indicados durante la fase DB
Periodo de tiempo: Fase DB: Línea de base; Semanas 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 y 44; Fin del Tratamiento (hasta la Semana 48); seguimiento de 4 semanas (FU) (hasta la semana 52); FU de 12 semanas (hasta la semana 60); y FU de 24 semanas (hasta la semana 72)
La frecuencia cardíaca se midió en los participantes en los puntos de tiempo indicados. El cambio medio desde la línea de base se calculó como el valor en los puntos de tiempo indicados menos el valor en la línea de base.
Fase DB: Línea de base; Semanas 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 y 44; Fin del Tratamiento (hasta la Semana 48); seguimiento de 4 semanas (FU) (hasta la semana 52); FU de 12 semanas (hasta la semana 60); y FU de 24 semanas (hasta la semana 72)
Cambio medio desde el inicio en el peso en los puntos de tiempo indicados durante la fase DB
Periodo de tiempo: Fase DB: Línea de base; Semanas 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 y 44; Fin del Tratamiento (hasta la Semana 48); seguimiento de 4 semanas (FU) (hasta la semana 52); FU de 12 semanas (hasta la semana 60); y FU de 24 semanas (hasta la semana 72)
El peso de los participantes se registró en los puntos de tiempo indicados. El cambio medio desde la línea de base se calculó como el valor en los puntos de tiempo indicados menos el valor en la línea de base.
Fase DB: Línea de base; Semanas 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 y 44; Fin del Tratamiento (hasta la Semana 48); seguimiento de 4 semanas (FU) (hasta la semana 52); FU de 12 semanas (hasta la semana 60); y FU de 24 semanas (hasta la semana 72)
Cambio medio desde el inicio en el índice de masa corporal (IMC) en los puntos de tiempo indicados durante la fase DB
Periodo de tiempo: Fase DB: Línea de base; Semanas 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 y 44; Fin del Tratamiento (hasta la Semana 48); seguimiento de 4 semanas (FU) (hasta la semana 52); FU de 12 semanas (hasta la semana 60); y FU de 24 semanas (hasta la semana 72)
El IMC de los participantes se calculó en los puntos de tiempo indicados como el peso corporal en kilogramos dividido por la altura en metros al cuadrado. El cambio medio desde la línea de base se calculó como el valor en los puntos de tiempo indicados menos el valor en la línea de base.
Fase DB: Línea de base; Semanas 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 y 44; Fin del Tratamiento (hasta la Semana 48); seguimiento de 4 semanas (FU) (hasta la semana 52); FU de 12 semanas (hasta la semana 60); y FU de 24 semanas (hasta la semana 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

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Patrocinador

GlaxoSmithKline

Publicaciones y enlaces útiles

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Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de octubre de 2007

Finalización primaria (Actual)

1 de abril de 2011

Finalización del estudio (Actual)

1 de mayo de 2011

Fechas de registro del estudio

Enviado por primera vez

13 de agosto de 2007

Primero enviado que cumplió con los criterios de control de calidad

13 de agosto de 2007

Publicado por primera vez (Estimar)

15 de agosto de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

5 de noviembre de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

10 de octubre de 2013

Última verificación

1 de agosto de 2012

Más información

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Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • TPL103922

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