SB497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Thrombocytopenia Due To Hepatitis C

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C, Chronic, Hepatitis C, Thrombocytopenia

In brief

SB497115 is an oral agent which activates the thrombopoietin receptor and increases platelet counts in healthy volunteers. This study is examining several different doses of SB497115 as a treatment for patients with chronic hepatitis C-related thrombocytopenia who are potential candidates for antiviral treatment with pegylated interferon and ribavirin. The study will be conducted in two phases, Parts 1 and 2. In Part 1, study subjects will be randomized to 4 weeks of SB-497115-GR or placebo administered daily without antiviral therapy. Subjects who successfully complete Part 1 (platelet count 70,000/µL for Pegasys and platelet count 100,000/µL for PEG-Intron) will then proceed to Part 2. In Part 2, subjects will receive an additional 8 weeks of SB-497115-GR or placebo administered daily with antiviral therapy.

Key facts

Study ID

NCT00110799

Run by

GlaxoSmithKline

People needed

75

Starts

2005-04-01

Expected to finish

2006-11-01

Last updated by the study team

2012-06-04

Who can join

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

You may qualify if…

• Chronic low platelet count between 20,000 and <70,000/µL.
• Prior liver biopsy indicating chronic hepatitis within the previous 5 years or radiographic evidence of cirrhosis and / or endoscopic evidence of non-bleeding esophageal or gastric varices.

You may not qualify if…

• History of heart attack or abnormal heart function.
• History of thrombosis within 1 year.
• History of alcohol or drug abuse or dependence within 1 year.
• Use of aspirin, aspirin-containing compounds, salicylates, antacids.
• History of HIV infection or active infection with Hepatitis B or C.
• Females who are pregnant.
• Patients using non-steroidal anti-inflammatory drugs during the study and within 3 weeks prior to starting the study.

Where it is running

• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Detroit, Michigan, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — Durham, North Carolina, United States
• GSK Investigational Site — San Antonio, Texas, United States
• GSK Investigational Site — Fairfax, Virginia, United States
• GSK Investigational Site — Richmond, Virginia, United States
• GSK Investigational Site — Clermont Ferrand Cédex 1, France
• GSK Investigational Site — Clichy, France
• GSK Investigational Site — Lyon, France
• GSK Investigational Site — Lyon, France
• GSK Investigational Site — Marseille, France
• GSK Investigational Site — Nice, France
• GSK Investigational Site — Paris, France
• GSK Investigational Site — Pessac, France
• GSK Investigational Site — Vandœuvre-lès-Nancy, France
• GSK Investigational Site — Heidelberg, Baden-Wurttemberg, Germany
• GSK Investigational Site — Hamburg, Free and Hanseatic City of Hamburg, Germany
• GSK Investigational Site — Frankfurt am Main, Hesse, Germany
• GSK Investigational Site — Hanover, Lower Saxony, Germany
• GSK Investigational Site — Homburg, Saarland, Germany
• GSK Investigational Site — Berlin, State of Berlin, Germany
• GSK Investigational Site — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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