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

NCT ID: NCT00529568

Last Updated: 2013-11-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

759 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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Hepatitis C, Chronic

Keywords

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hepatitis C ribavirin Hepatitis C-related thrombocytopenia thrombopoietin peginterferon alfa-2b platelets

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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eltrombopag

active treatment arm

Group Type EXPERIMENTAL

eltrombopag

Intervention Type DRUG

double-blind active treatment daily oral administation at dose of 25, 50, 75, or 100 mg

placebo

placebo control arm

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

double-blind matched placebo control daily oral administration

Interventions

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eltrombopag

double-blind active treatment daily oral administation at dose of 25, 50, 75, or 100 mg

Intervention Type DRUG

placebo

double-blind matched placebo control daily oral administration

Intervention Type DRUG

Eligibility Criteria

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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, 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Birmingham, Alabama, United States

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Tucson, Arizona, United States

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Anaheim, California, United States

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Arcadia, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Lynwood, California, United States

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Sacramento, California, United States

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San Clemente, California, United States

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San Diego, California, United States

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San Mateo, California, United States

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Aurora, Colorado, United States

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New Haven, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Bradenton, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Honolulu, Hawaii, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Lexington, Kentucky, United States

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New Orleans, Louisiana, United States

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Boston, Massachusetts, United States

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Burlington, Massachusetts, United States

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Worcester, Massachusetts, United States

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Detroit, Michigan, United States

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Detroit, Michigan, United States

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Jackson, Mississippi, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Lebanon, New Hampshire, United States

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Manhasset, New York, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Syracuse, New York, United States

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The Bronx, New York, United States

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Asheville, North Carolina, United States

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Durham, North Carolina, United States

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Kinston, North Carolina, United States

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Morganton, North Carolina, United States

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Tulsa, Oklahoma, United States

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Portland, Oregon, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Germantown, Tennessee, United States

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Mountain Home, Tennessee, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Galveston, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Charlottesville, Virginia, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Garran, Australian Capital Territory, Australia

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Camperdown, New South Wales, Australia

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Randwick, New South Wales, Australia

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Cairns, Queensland, Australia

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Herston, Queensland, Australia

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Clayton, Victoria, Australia

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Fitzroy, Victoria, Australia

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Parkville, Victoria, Australia

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Prahran, Victoria, Australia

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Nedlands, Western Australia, Australia

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Brussels, , Belgium

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Edegem, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Campinas, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Edmonton, Alberta, Canada

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Victoria, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Barrie, Ontario, Canada

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Hamilton, Ontario, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Hradec Králové, , Czechia

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Olomouc, , Czechia

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Prague, , Czechia

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Al Mansurah, , Egypt

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Cairo, , Egypt

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Shebeen El-Kom, Menoufeya, , Egypt

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Besançon, , France

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Bondy, , France

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Dijon, , France

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Grenoble, , France

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Lille, , France

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Marseille, , France

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Orléans, , France

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Paris, , France

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Paris, , France

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Rouen, , France

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Strasbourg, , France

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Vandœuvre-lès-Nancy, , France

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Freiburg im Breisgau, Baden-Wurttemberg, Germany

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Heidelberg, Baden-Wurttemberg, Germany

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Mannheim, Baden-Wurttemberg, Germany

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Stuttgart, Baden-Wurttemberg, Germany

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Ulm, Baden-Wurttemberg, Germany

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Deggendorf, Bavaria, Germany

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Hof/Saale, Bavaria, Germany

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Munich, Bavaria, Germany

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Munich, Bavaria, Germany

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Regensburg, Bavaria, Germany

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Würzburg, Bavaria, Germany

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Beeskow, Brandenburg, Germany

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Hamburg, City state of Hamburg, Germany

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Hamburg, City state of Hamburg, Germany

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Frankfurt am Main, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Kassel, Hesse, Germany

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Göttingen, Lower Saxony, Germany

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Hanover, Lower Saxony, Germany

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Hanover, Lower Saxony, Germany

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Rotenburg (Wümme), Lower Saxony, Germany

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Aachen, North Rhine-Westphalia, Germany

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Bochum, North Rhine-Westphalia, Germany

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Bonn, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Dortmund, North Rhine-Westphalia, Germany

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Düsseldorf, North Rhine-Westphalia, Germany

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Essen, North Rhine-Westphalia, Germany

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Herne, North Rhine-Westphalia, Germany

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Leverkusen, North Rhine-Westphalia, Germany

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Münster, North Rhine-Westphalia, Germany

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Oberhausen, North Rhine-Westphalia, Germany

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Siegen, North Rhine-Westphalia, Germany

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Mainz, Rhineland-Palatinate, Germany

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Chemnitz, Saxony, Germany

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Leipzig, Saxony, Germany

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Halle, Saxony-Anhalt, Germany

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Magdeburg, Saxony-Anhalt, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Athens, , Greece

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Athens, , Greece

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Rio, Patras, , Greece

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Thessaloniki, , Greece

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Bangalore, , India

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Chennai, , India

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Hyderabad, , India

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Mumbai, , India

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Mumbai, , India

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Mumbai, , India

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Haifa, , Israel

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Haifa, , Israel

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Jerusalem, , Israel

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Nazareth, , Israel

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Petah Tikva, , Israel

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Rehovot, , Israel

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Safed, , Israel

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Tel Aviv, , Israel

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Bari, Apulia, Italy

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San Giovanni Rotondo (FG), Apulia, Italy

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Catanzaro, Calabria, Italy

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Avellino, Campania, Italy

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Bologna, Emilia-Romagna, Italy

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Rome, Lazio, Italy

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Genoa, Liguria, Italy

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Brescia, Lombardy, Italy

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Milan, Lombardy, Italy

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Milan, Lombardy, Italy

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Palermo, Sicily, Italy

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Lahore, , Pakistan

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Lahore, , Pakistan

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Chorzów, , Poland

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Kielce, , Poland

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Racibórz, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Ponce, Puerto Rico, Puerto Rico

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San Juan, Puerto Rico, Puerto Rico

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Bucharest, , Romania

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Constanța, , Romania

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Moscow, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

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St.Peterburg, , Russia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Martin, , Slovakia

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Busan, , South Korea

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Daegu, , South Korea

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Pusan, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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A Coruña, , Spain

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Alicante, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Palma de Mallorca, , Spain

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Pontevedra, , Spain

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Sabadell (Barcelona), , Spain

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San Sebastián, , Spain

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Seville, , Spain

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Valencia, , Spain

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Valencia, , Spain

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Changhua, , Taiwan

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Chia-Yi Hsien, , Taiwan

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Kaohsiung City, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Taiyuan Hsien, , Taiwan

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Donetsk, , Ukraine

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Kiev, , Ukraine

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Vinnitsa, , Ukraine

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Countries

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Argentina Netherlands New Zealand United States Australia Belgium Brazil Canada Czechia Egypt France Germany Greece India Israel Italy Pakistan Poland Puerto Rico Romania Russia Slovakia South Korea Spain Taiwan Ukraine

References

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Saleh MI, Obeidat AR, Anter HA, Khanfar AA. Eltrombopag dose predictors in thrombocytopenic subjects with hepatitis C virus infection. Clin Exp Pharmacol Physiol. 2015 Oct;42(10):1030-5. doi: 10.1111/1440-1681.12451.

Reference Type DERIVED
PMID: 26173631 (View on PubMed)

Giannini EG, Afdhal NH, Sigal SH, Muir AJ, Reddy KR, Vijayaraghavan S, Elkashab M, Romero-Gomez M, Dusheiko GM, Iyengar M, Vasey SY, Campbell FM, Theodore D. Non-cirrhotic thrombocytopenic patients with hepatitis C virus: Characteristics and outcome of antiviral therapy. J Gastroenterol Hepatol. 2015 Aug;30(8):1301-8. doi: 10.1111/jgh.12942.

Reference Type DERIVED
PMID: 25777337 (View on PubMed)

Afdhal NH, Dusheiko GM, Giannini EG, Chen PJ, Han KH, Mohsin A, Rodriguez-Torres M, Rugina S, Bakulin I, Lawitz E, Shiffman ML, Tayyab GU, Poordad F, Kamel YM, Brainsky A, Geib J, Vasey SY, Patwardhan R, Campbell FM, Theodore D. Eltrombopag increases platelet numbers in thrombocytopenic patients with HCV infection and cirrhosis, allowing for effective antiviral therapy. Gastroenterology. 2014 Feb;146(2):442-52.e1. doi: 10.1053/j.gastro.2013.10.012. Epub 2013 Oct 12.

Reference Type DERIVED
PMID: 24126097 (View on PubMed)

Other Identifiers

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TPL108390

Identifier Type: -

Identifier Source: org_study_id