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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00516321 |
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 | Intervention | Phase |
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Thrombocytopenia Hepatitis C |
Drug: eltrombopag |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, 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 |
Estimated Enrollment: | 750 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male and female subjects, >18 years Evidence of chronic HCV infection Subjects who are appropriate candidates for pegIFN and ribavirin antiviral therapy A platelet count of <75,000/uL 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 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-Pugh score >6 or history of ascites or hepatic encephalopathy or current evidence of ascites Known hypersensitivity, intolerance or allergy to 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:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | TPL103922 |
Study First Received: | August 13, 2007 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00516321 |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
thrombopoietin hepatitis C Hepatitis C-related thrombocytopenia |
platelets peginterferon alfa-2a ribavirin |
Liver Diseases Hematologic Diseases Blood Platelet Disorders Ribavirin Interferons Benzocaine Hepatitis, Viral, Human |
Hepatitis Virus Diseases Thrombocytopathy Thrombocytopenia Digestive System Diseases Peginterferon alfa-2a Hepatitis C |
Anti-Infective Agents RNA Virus Infections Flaviviridae Infections |
Therapeutic Uses Antiviral Agents Pharmacologic Actions |