Loading clinical trials...

Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Subjects With Hepatitis C Related Liver Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT00516321•GlaxoSmithKline

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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, antithrombin III (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

Locations (191)

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

La Jolla, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

San Clemente, California, United States

GSK Investigational Site

Aurora, Colorado, United States

GSK Investigational Site

New Haven, Connecticut, United States

GSK Investigational Site

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

Key Dates

Start Date

October 1, 2007

Primary Completion Date

April 1, 2011

Completion Date

May 1, 2011

Last Updated

November 5, 2013

Enrollment

687

ACTUAL participants

Conditions

Hepatitis C, Chronic

Interventions

eltrombopag

DRUG

placebo

DRUG

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

NCT05870969

Carcinoma, HepatocellularHepatitis C, Chronic+3 more

View study

COMPLETEDPHASE4

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

NCT03987503

Hepatitis C, Chronic

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir

Safety And Efficacy Of Oral PF-4136309 In Patients With Chronic Hepatitis C Infection And Abnormal Liver Enzymes

Addition of ISIS 14803 to Therapy With Peginterferon and Ribavirin for Chronic Hepatitis C (HCV) Patients Not Responding Adequately to the Two Drugs

The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection