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

NCT00529568 | Completed Phase 3 Results

• 1 other identifier: TPL108390
• Study Type: interventional
• Target: 759
• Locations: 23 countries
• Sites: 227

Brief Summary

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).

Conditions

Hepatitis C, Chronic

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase

  Participants with SVR are defined as those with non-detectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at the end of treatment and all subsequent planned visits up to 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)

Secondary Outcomes (22)

• Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 100 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase

  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

  From Baseline up to Week 9 in the OL Phase

• Median Platelet Count at the Indicated Time Points During the OL Phase

  OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82)

• Median Platelet Count at the Indicated Time Points During the DB Phase

  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

  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)

Study Arms (2)

eltrombopag

EXPERIMENTAL

active treatment arm

Drug: eltrombopag

placebo

PLACEBO COMPARATOR

placebo control arm

Drug: placebo

Interventions

eltrombopag DRUG

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

eltrombopag

placebo DRUG

double-blind matched placebo control daily oral administration

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (227)

GSK Investigational Site

Birmingham, Alabama, 35294-0005, United States

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Tucson, Arizona, 85750, United States

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Anaheim, California, 92801, United States

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Arcadia, California, 91007, United States

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La Jolla, California, 92037, United States

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Los Angeles, California, 90017, United States

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Los Angeles, California, 90048, United States

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Lynwood, California, 90262, United States

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Sacramento, California, 95817, United States

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San Clemente, California, 92673, United States

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San Diego, California, 92123, United States

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San Mateo, California, 94403, United States

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Aurora, Colorado, 80045, United States

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New Haven, Connecticut, 06510, United States

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Washington D.C., District of Columbia, 20010, United States

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Washington D.C., District of Columbia, 20307, United States

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Bradenton, Florida, 34209, United States

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Jacksonville, Florida, 32207, United States

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Miami, Florida, 33125, United States

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Honolulu, Hawaii, 96817, United States

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Chicago, Illinois, 60612-3824, United States

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Indianapolis, Indiana, 46202, United States

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Lexington, Kentucky, 40536, United States

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New Orleans, Louisiana, 70112, United States

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Boston, Massachusetts, 02215, United States

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Burlington, Massachusetts, 01805, United States

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Worcester, Massachusetts, 01655, United States

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Detroit, Michigan, 48201, United States

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Detroit, Michigan, 48202, United States

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Jackson, Mississippi, 39202, United States

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St Louis, Missouri, 63104, United States

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St Louis, Missouri, 63110, United States

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Lebanon, New Hampshire, 03756, United States

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Manhasset, New York, 11030, United States

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New York, New York, 10016, United States

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New York, New York, 10021, United States

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Rochester, New York, 14642, United States

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Syracuse, New York, 13210, United States

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The Bronx, New York, 10468, United States

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Asheville, North Carolina, 28801, United States

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Durham, North Carolina, 27710, United States

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Kinston, North Carolina, 28501, United States

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Morganton, North Carolina, 28655, United States

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Tulsa, Oklahoma, 74104, United States

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Portland, Oregon, 97239, United States

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Hershey, Pennsylvania, 17033-0850, United States

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Philadelphia, Pennsylvania, 19104, United States

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Germantown, Tennessee, 38138, United States

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Mountain Home, Tennessee, 37684, United States

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Nashville, Tennessee, 37203, United States

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Nashville, Tennessee, 37205, United States

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Nashville, Tennessee, 37212, United States

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Dallas, Texas, 75203, United States

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Galveston, Texas, 77555-0435, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78215, United States

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Charlottesville, Virginia, 22908, United States

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Richmond, Virginia, 23249, United States

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Seattle, Washington, 98111, United States

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Garran, Australian Capital Territory, 2606, Australia

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Camperdown, New South Wales, 2050, Australia

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Randwick, New South Wales, 2031, Australia

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Cairns, Queensland, 4870, Australia

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Herston, Queensland, 4029, Australia

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Clayton, Victoria, 3168, Australia

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Fitzroy, Victoria, 3065, Australia

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Parkville, Victoria, 3050, Australia

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Prahran, Victoria, 3181, Australia

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Nedlands, Western Australia, 6009, Australia

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Brussels, 1200, Belgium

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Edegem, 2650, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Campinas, São Paulo, 13083-888, Brazil

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São Paulo, São Paulo, 04023900, Brazil

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Edmonton, Alberta, T6G 2C8, Canada

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Victoria, British Columbia, V8V 3P9, Canada

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Winnipeg, Manitoba, R3E 3P4, Canada

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Barrie, Ontario, L4M 7G1, Canada

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Hamilton, Ontario, L8L 2X2, Canada

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Hamilton, Ontario, L8N 4A6, Canada

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London, Ontario, N6A 5A5, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M5G 1X5, Canada

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Toronto, Ontario, M5G 2C4, Canada

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Toronto, Ontario, M5T 2S8, Canada

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Toronto, Ontario, M6H 3M1, Canada

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Montreal, Quebec, H2X 3J4, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Hradec Králové, 500 12, Czechia

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Olomouc, 775 20, Czechia

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Prague, 169 02, Czechia

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Al Mansurah, 35516, Egypt

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Cairo, Egypt

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Shebeen El-Kom, Menoufeya, 35111, Egypt

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Besançon, 25030, France

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Bondy, 93140, France

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Dijon, 21019, France

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Grenoble, 38043, France

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Lille, 59037, France

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Marseille, 13285, France

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Orléans, 45100, France

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Paris, 75571, France

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Paris, 75651, France

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Rouen, 76000, France

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Strasbourg, 67091, France

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Vandœuvre-lès-Nancy, 54511, France

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Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

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Heidelberg, Baden-Wurttemberg, 69120, Germany

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Mannheim, Baden-Wurttemberg, 68167, Germany

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Stuttgart, Baden-Wurttemberg, 70197, Germany

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Ulm, Baden-Wurttemberg, 89081, Germany

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Deggendorf, Bavaria, 94469, Germany

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Hof/Saale, Bavaria, 95028, Germany

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Munich, Bavaria, 81377, Germany

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Munich, Bavaria, 81675, Germany

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Regensburg, Bavaria, 93049, Germany

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Würzburg, Bavaria, 97080, Germany

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Beeskow, Brandenburg, 15848, Germany

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Hamburg, Hamburg, 20099, Germany

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Hamburg, Hamburg, 20246, Germany

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Frankfurt am Main, Hesse, 60590, Germany

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Frankfurt am Main, Hesse, 60596, Germany

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Kassel, Hesse, 34127, Germany

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Göttingen, Lower Saxony, 37075, Germany

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Hanover, Lower Saxony, 30159, Germany

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Hanover, Lower Saxony, 30625, Germany

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Rotenburg (Wümme), Lower Saxony, 27356, Germany

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Aachen, North Rhine-Westphalia, 52074, Germany

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Bochum, North Rhine-Westphalia, 44787, Germany

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Bonn, North Rhine-Westphalia, 53127, Germany

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Cologne, North Rhine-Westphalia, 50937, Germany

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Dortmund, North Rhine-Westphalia, 44263, Germany

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Düsseldorf, North Rhine-Westphalia, 40225, Germany

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Essen, North Rhine-Westphalia, 45122, Germany

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Herne, North Rhine-Westphalia, 44623, Germany

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Leverkusen, North Rhine-Westphalia, 51375, Germany

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Münster, North Rhine-Westphalia, 48143, Germany

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Oberhausen, North Rhine-Westphalia, 46045, Germany

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Siegen, North Rhine-Westphalia, 57072, Germany

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Mainz, Rhineland-Palatinate, 55131, Germany

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Chemnitz, Saxony, 09116, Germany

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Leipzig, Saxony, 04129, Germany

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Halle, Saxony-Anhalt, 06120, Germany

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Magdeburg, Saxony-Anhalt, 39120, Germany

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Berlin, State of Berlin, 10439, Germany

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Berlin, State of Berlin, 10969, Germany

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Berlin, State of Berlin, 12203, Germany

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Berlin, State of Berlin, 13353, Germany

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Athens, 10676, Greece

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Athens, 115 27, Greece

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Rio, Patras, 265 04, Greece

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Thessaloniki, 546 42, Greece

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Bangalore, 560054, India

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Chennai, 600 096, India

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Hyderabad, 500082, India

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Mumbai, 400 008, India

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Mumbai, 400 016, India

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Mumbai, 400036, India

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Haifa, 31096, Israel

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Haifa, 34362, Israel

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Jerusalem, 91120, Israel

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Nazareth, 16100, Israel

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Petah Tikva, 49100, Israel

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Rehovot, 76100, Israel

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Safed, 13110, Israel

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Tel Aviv, 64239, Israel

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Bari, Apulia, 70124, Italy

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San Giovanni Rotondo (FG), Apulia, 71013, Italy

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Catanzaro, Calabria, 88100, Italy

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Avellino, Campania, 83100, Italy

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Bologna, Emilia-Romagna, 40138, Italy

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Rome, Lazio, 00133, Italy

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Genoa, Liguria, 16132, Italy

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Brescia, Lombardy, 25123, Italy

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Milan, Lombardy, 20132, Italy

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Milan, Lombardy, 20157, Italy

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Palermo, Sicily, 90127, Italy

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Lahore, 54000, Pakistan

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Lahore, 54600, Pakistan

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Chorzów, 41-500, Poland

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Kielce, 25-317, Poland

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Racibórz, 47-400, Poland

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Szczecin, 71-455, Poland

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Warsaw, 01-201, Poland

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Wroclaw, 51-149, Poland

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Ponce, Puerto Rico, 00717, Puerto Rico

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San Juan, Puerto Rico, 00927, Puerto Rico

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Bucharest, 021105, Romania

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Constanța, 900709, Romania

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Moscow, 107014, Russia

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Saint Petersburg, 191167, Russia

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Samara, 443011, Russia

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St.Peterburg, 190103, Russia

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Bratislava, 811 07, Slovakia

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Bratislava, 833 05, Slovakia

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Košice, 041 66, Slovakia

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Martin, 036 59, Slovakia

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Busan, 614-735, South Korea

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Daegu, 700-721, South Korea

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Pusan, 602-739, South Korea

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Seoul, 120-752, South Korea

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Seoul, 135-720, South Korea

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A Coruña, 15006, Spain

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Alicante, 03010, Spain

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Barcelona, 08003, Spain

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Barcelona, 08035, Spain

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Madrid, 28006, Spain

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Madrid, 28007, Spain

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Madrid, 28034, Spain

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Málaga, 29010, Spain

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Palma de Mallorca, 07010, Spain

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Pontevedra, 36071, Spain

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Sabadell (Barcelona), 08208, Spain

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San Sebastián, 20014, Spain

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Seville, 41014, Spain

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Valencia, 46009, Spain

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Valencia, 46010, Spain

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Changhua, 500, Taiwan

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Chia-Yi Hsien, 613, Taiwan

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Kaohsiung City, 833, Taiwan

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Taichung, 404, Taiwan

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Taipei, 112, Taiwan

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Taiyuan Hsien, 333, Taiwan

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Donetsk, 83114, Ukraine

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Kiev, 01030, Ukraine

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Vinnitsa, 21021, Ukraine

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Related Publications (3)

• 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.

  PMID: 26173631 DERIVED

• 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.

  PMID: 25777337 DERIVED

• 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.

  PMID: 24126097 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C; Jacobs syndrome

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2007
• First Posted: September 14, 2007
• Study Start: October 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 5, 2013
• Results First Posted: May 17, 2012

Record last verified: 2013-03

Locations

SL (4); UA (3); KR (5); FR (12); BR (2); CZ (3); AU (10); IT (11); RO (2); RU (4); DE (42); US (59); BE (4); CA (14); GR (4); IN (6); IL (8); PA (2); PL (6); PR (2); ES (15); TW (6); EG (3)