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

PHASE2CompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

April 30, 2005

Primary Completion Date

October 31, 2006

Study Completion Date

November 30, 2006

Conditions
Hepatitis C, ChronicHepatitis CThrombocytopenia
Interventions
DRUG

SB497115

Approximately 160 subjects will be randomized equally to one of four treatment groups of approximately 40 subjects (A-D). Subjects will receive oral tablets of SB-497115-GR at 30mg, 50 mg, 75 mg or placebo administered once daily for a total of 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy.

OTHER

Placebo

Placebo administered orally daily for 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy.

Trial Locations (30)

10021

GSK Investigational Site, New York

13285

GSK Investigational Site, Marseille

13353

GSK Investigational Site, Berlin

20246

GSK Investigational Site, Hamburg

22031

GSK Investigational Site, Fairfax

23249

GSK Investigational Site, Richmond

27710

GSK Investigational Site, Durham

30625

GSK Investigational Site, Hanover

33604

GSK Investigational Site, Pessac

48202

GSK Investigational Site, Detroit

54511

GSK Investigational Site, Vandœuvre-lès-Nancy

60590

GSK Investigational Site, Frankfurt am Main

63058

GSK Investigational Site, Clermont Ferrand Cédex 1

63104

GSK Investigational Site, St Louis

66421

GSK Investigational Site, Homburg

69120

GSK Investigational Site, Heidelberg

69288

GSK Investigational Site, Lyon

69437

GSK Investigational Site, Lyon

75571

GSK Investigational Site, Paris

78215

GSK Investigational Site, San Antonio

80262

GSK Investigational Site, Denver

92118

GSK Investigational Site, Clichy

02215

GSK Investigational Site, Boston

06202

GSK Investigational Site, Nice

00909-1711

GSK Investigational Site, San Juan

BS2 8HW

GSK Investigational Site, Bristol

G12 0YN

GSK Investigational Site, Glasgow

NG7 2UH

GSK Investigational Site, Nottingham

NW3 2QG

GSK Investigational Site, London

W2 1NY

GSK Investigational Site, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY