SB497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Thrombocytopenia Due To Hepatitis C
Status:
Completed
Trial end date:
2006-11-01
Target enrollment:
Participant gender:
Summary
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.