Clinical Trial for Non-responders Who Previously Participated in Eltrombopag Studies TPL 103922 or TPL 108390

Completed · Phase 3

Conditions studied: Hepatitis C

In brief

The purpose of this study is to test the safety and tolerability of eltrombopag when used to increase and maintain platelet count. Platelet count to be maintained at a level sufficient to facilitate initiation of antiviral therapy, to minimize antiviral therapy dose reductions, and to avoid permanent discontinuation of antiviral therapy.

Key facts

Study ID

NCT00996216

Run by

GlaxoSmithKline

People needed

27

Starts

2009-09-01

Expected to finish

2013-02-01

Last updated by the study team

2013-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prior participation in protocol TPL103922 or TPL108390 and completed the Week 24 Follow Up Visit in TPL103922 or TPL108390
• Male or female ≥18 years old
• Evidence of chronic HCV infection
• While participating in TPL103922 or TPL108390, discontinued from study drug due to thrombocytopenia
• Appropriate candidate for antiviral therapy with pegylated interferon plus ribavirin
• Platelet count <75,000
• Fertile males and females must use two forms of effective contraception during treatment and for 24 weeks after treatment
• Ability to understand and comply with the protocol requirements and instructions
• Ability to provide written informed consent

You may not qualify if…

• Decompensated liver disease
• Known hypersensitivity, intolerance, or allergy to interferon, ribavirin, eltrombopag, or their ingredients
• History of clinically significant bleeding from oesophageal or gastric varices
• History of arterial or venous thrombosis and two or more of the following risk factors: hereditary thrombophilic disorders; hormone replacement therapy; systemic contraception (containing estrogen); smoking; diabetes; hypercholesterolemia; medication for hypertension or cancer
• Pre-existing cardiac disease (congestive heart failure Grade III/IV) or arrhythmias known to involve the risk of thromboembolic events (e.g. atrial fibrillation)
• Evidence of hepatocellular carcinoma
• HIV or Hepatitis B infection
• Therapy with anti-neoplastic or immunomodulatory treatment within six months prior to eltrombopag therapy
• Malignancy diagnosed or treated within the past five years. Except for localized basal or squamous cell carcinoma treated by local excision or malignancies that were adequately treated and, in the opinion of the oncologist, have an excellent chance of cancer-free survival.
• Pregnant or nursing women
• Men with a female partner who is pregnant
• History of alcohol/drug abuse or dependence within six months of the study start unless participating in a controlled rehabilitation programme.
• Treatment with an investigational drug or interferon within 30 days or 5 half-lives (whichever is longer) of the screening visit
• History or platelet clumping that prevents reliable measurement of platelet counts
• Evidence of portal vein thrombosis within three months of baseline visit

Where it is running

• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — New Haven, Connecticut, United States
• GSK Investigational Site — Honolulu, Hawaii, United States
• GSK Investigational Site — Manhasset, New York, United States
• GSK Investigational Site — Nashville, Tennessee, United States
• GSK Investigational Site — Seattle, Washington, United States
• GSK Investigational Site — Camperdown, New South Wales, Australia
• GSK Investigational Site — Randwick, New South Wales, Australia
• GSK Investigational Site — Herston, Queensland, Australia
• GSK Investigational Site — Toronto, Ontario, Canada
• GSK Investigational Site — Montreal, Quebec, Canada
• GSK Investigational Site — Marseille, France
• GSK Investigational Site — Nice, France
• GSK Investigational Site — Pessac, France
• GSK Investigational Site — Freiburg im Breisgau, Baden-Wurttemberg, Germany
• GSK Investigational Site — Ulm, Baden-Wurttemberg, Germany
• GSK Investigational Site — Munich, Bavaria, Germany
• GSK Investigational Site — Düsseldorf, North Rhine-Westphalia, Germany
• GSK Investigational Site — Berlin, State of Berlin, Germany
• GSK Investigational Site — Athens, Greece
• GSK Investigational Site — Bologna, Emilia-Romagna, Italy
• GSK Investigational Site — Genoa, Liguria, Italy
• GSK Investigational Site — Milan, Lombardy, Italy
• GSK Investigational Site — Lahore, Pakistan
• GSK Investigational Site — A Coruña, Spain

Full record on ClinicalTrials.gov

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