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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 13, 2007 | ||||
| Last Updated Date | November 5, 2009 | ||||
| Start Date ICMJE | October 2007 | ||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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) | ||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||
| Change History | Complete list of historical versions of study NCT00516321 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. | ||||
| Original Secondary Outcome Measures ICMJE |
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 ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Subjects With Hepatitis C Related Liver Disease | ||||
| Official Title ICMJE | 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 | ||||
| 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). |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: eltrombopag | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 750 | ||||
| Estimated Completion Date | August 2011 | ||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Korea, Republic of, Netherlands, Pakistan, Poland, Puerto Rico, Romania, Russian Federation, Slovakia, Spain, Taiwan, Thailand, Ukraine, United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00516321 | ||||
| Responsible Party | Study Director, GSK | ||||
| Study ID Numbers ICMJE | TPL103922 | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | November 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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