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Eltrombopag Phase III study to Initiate and Maintain Interferon Antiviral Treatment to Subjects With Hepatitis C Related Liver Disease
 
 
  This study is not yet open for patient recruitment.
Verified by GlaxoSmithKline August 2007 Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00516321
 
Purpose 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).
 
Condition: Thrombocytopenia,Hepatitis C
Drug: eltrombopag
Phase III
 
MedlinePlus related topics: Bleeding Disorders; Hepatitis
Genetics Home Reference related topics: Bleeding Disorders
 
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
 
Official Title: 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 Further study details as provided by GlaxoSmithKline:
 
Primary Outcome Measures:
· SVR rate defined as percentage of subjects with non-detectable HCV-RNA at 24 weeks post-completion of the planned treatment period (i.e., Week 48 for genotype 2/3 or Week 72 for non-genotype 2/3) [Time Frame: 24 Weeks]
 
Secondary Outcome Measures:
· Proportion of subjects with a shift in platelet count from <75,000/μL to >/=90,000/μL. Adverse events, laboratory abnormalities, ocular examinations, 12-lead ECGs, and clinical monitoring/observation. [Time Frame: 24 Weeks]
 
Total Enrollment: 750
 
Study start: August 2007
 
Eligibility Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both Criteria
 
Inclusion Criteria:
· Male and female subjects, aged >/=18 years.
· Chronic HCV infection (i.e. detectable HCV RNA).
· Suitable for treatment with peginterferon alfa-2a and ribavirin combination antiviral therapy.
· An entry platelet count of <75,000/μL
· Haemoglobin concentration >/=11.0g/dL for men or >/=10.0g/dL for women. · Absolute neutrophil count >/=750/mm3 and no history of infections associated with neutropenia.
 
Exclusion Criteria:
· Non-responders to previous treatment with peginterferon and ribavirin who failed to achieve a SVR for reasons other than thrombocytopenia, despite an optimal course (dose and duration) of combination therapy with peginterferon and ribavirin.
· Decompensated liver disease, e.g. Child-Turcotte-Pugh score >6, or history of ascites or hepatic encephalopathy or current evidence of ascites. · Infection with Human Immunodeficiency Virus (HIV) or active Hepatitis B Virus (HBV) infection.
· History of alcohol/drug abuse or dependence within 6 months of the study start (unless participating in a controlled rehabilitation programme). · Pregnant or nursing women, or males with a female partner who is pregnant.
 
Location and Contact Information Please refer to this study by ClinicalTrials.gov identifier NCT00516321
 
United States, Arizona
GSK Clinical Trials Call Center, Tucson, Arizona, 85724, United States Thomas Boyer 877-379-3718
 
United States, California
GSK Clinical Trials Call Center, San Clemente, California, 92673, United States Tarek Hassanein 877-379-3718
 
GSK Clinical Trials Call Center, Sacramento, California, 95825, United States Mary Pauly 877-379-3718
 
GSK Clinical Trials Call Center, La Jolla, California, 92037, United States Paul Pockros 877-379-3718
 
GSK Clinical Trials Call Center, Los Angeles, California, 90048, United States Fred Poordad 877-379-3718
 
United States, Colorado
GSK Clinical Trials Call Center, Englewood, Colorado, 80113, United States Marcelo Kugelmas 877-379-3718
 
GSK Clinical Trials Call Center, Denver, Colorado, 80262, United States Gregory Everson 877-379-3718
 
United States, Connecticut
GSK Clinical Trials Call Center, New Haven, Connecticut, 06520, United States Joseph Lim 877-379-3718
 
United States, District of Columbia
GSK Clinical Trials Call Center, Washington, District of Columbia, 20010, United States Averell Sherker 877-379-3718
 
United States, Florida
GSK Clinical Trials Call Center, Miami, Florida, 33125, United States Lennox Jeffers 877-379-3718
 
United States, Georgia
GSK Clinical Trials Call Center, Atlanta, Georgia, 30309, United States Raymond Rubin 877-379-3718 Ext. 158
 
United States, Kentucky
GSK Clinical Trials Call Center, Lexington, Kentucky, 40536, United States Alvaro Koch 877-379-3718
 
GSK Clinical Trials Call Center, Louisville, Kentucky, 40202, United States Luis Marsano 877-379-3718
 
United States, Maryland
GSK Clinical Trials Call Center, Lutherville, Maryland, 21093, United States Paul Thuluvath 877-379-3718
 
United States, Massachusetts
GSK Clinical Trials Call Center, Worcester, Massachusetts, 01655, United States Gyongyi Szabo 877-379-3718
 
GSK Clinical Trials Call Center, Burlington, Massachusetts, 01805, United States Frederic Gordon 877-379-3718
 
United States, Missouri
GSK Clinical Trials Call Center, St. Louis, Missouri, 63104, United States Bruce Bacon 877-379-3718
 
GSK Clinical Trials Call Center, St. Louis, Missouri, 63130, United States Mauricio Lisker-Melman 877-379-3718
 
United States, New York
GSK Clinical Trials Call Center, Bronx, New York, 10468, United States Norbert Brau 877-379-3718 Ext. 3874
 
GSK Clinical Trials Call Center, Syracuse, New York, 13210, United States Robert Lewis 877-379-3718
 
GSK Clinical Trials Call Center, Rochester, New York, 14642, United States Benedict Maliakkal 877-379-3718
 
GSK Clinical Trials Call Center, Valhalla, New York, 10595, United States Edward Lebovics 877-379-3718
 
United States, North Carolina
GSK Clinical Trials Call Center, Durham, North Carolina, 27710, United States John McHutchison 877-379-3718
 
United States, Ohio
GSK Clinical Trials Call Center, Cincinnati, Ohio, 45267, United States Guy Neff 877-379-3718
 
United States, Pennsylvania
GSK Clinical Trials Call Center, Hershey, Pennsylvania, 17033, United States Thomas Riley 877-379-3718
 
United States, Texas
GSK Clinical Trials Call Center, San Antonio, Texas, 78215, United States Eric Lawitz 877-379-3718
 
GSK Clinical Trials Call Center, Houston, Texas, 77030, United States Boris Yoffe 877-379-3718 Ext. 5619
 
United States, Virginia GSK Clinical Trials Call Center, Fairfax, Virginia, 22031, United States Vinod Rustgi 877-379-3718 Ext. 16
 
GSK Clinical Trials Call Center, Richmond, Virginia, 23298, United States Mitchell Shiffman 877-379-3718
 
Canada, Alberta
GSK Clinical Trials Call Center, Calgary, Alberta, T2N 4N1, Canada GSK Clinical Trials Call Center 1-877-379-3718
 
Canada, British Columbia
GSK Clinical Trials Call Center, Victoria, British Columbia, V8V 3P9, Canada GSK Clinical Trials Call Center 1-877-379-3718
 
Canada, Ontario
GSK Clinical Trials Call Center, Richmond Hill, Ontario, L4C 4Z3, Canada GSK Clinical Trials Call Center 1-877-379-3718
 
GSK Clinical Trials Call Center, Toronto, Ontario, M5G 1X3, Canada GSK Clinical Trials Call Center 1-877-379-3718
 
GSK Clinical Trials Call Center, Toronto, Ontario, M5T 2S8, Canada GSK Clinical Trials Call Center 1-877-379-3718
 
GSK Clinical Trials Call Center, Barrie, Ontario, L4M 5G1, Canada GSK Clinical Trials Call Center 1-877-379-3718
 
GSK Clinical Trials Call Center, Ottawa, Ontario, K1N 6N5, Canada GSK Clinical Trials Call Center 1-877-379-3718 Ext. 274
 
GSK Clinical Trials Call Center, Hamilton, Ontario, L8N 4A6, Canada GSK Clinical Trials Call Center 1-877-379-3718
 
GSK Clinical Trials Call Center, Ottawa, Ontario, K1H 8L6, Canada GSK Clinical Trials Call Center 1-877-379-3718 Ext. 72723
 
GSK Clinical Trials Call Center, Toronto, Ontario, M5G 2C4, Canada GSK Clinical Trials Call Center 1-877-379-3718 Ext. 2099
 
GSK Clinical Trials Call Center, Hamilton, Ontario, L8L 2X2, Canada GSK Clinical Trials Call Center 1-877-379-3718
 
GSK Clinical Trials Call Center, Windsor, Ontario, N9A 1C9, Canada GSK Clinical Trials Call Center 1-877-379-3718
 
GSK Clinical Trials Call Center, London, Ontario, N6A 5A5, Canada GSK Clinical Trials Call Center 1-877-379-3718 Ext. 34712
 
Canada, Quebec
GSK Clinical Trials Call Center, Montreal, Quebec, H3T 1E2, Canada GSK Clinical Trials Call Center 1-877-379-3718 Ext. 5429
 
Study chairs or principal investigators
 
GSK Clinical Trials, MD, Study Director, GlaxoSmithKline
 
 
 
 
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