SB497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Thrombocytopenia Due To Hepatitis C
A Double-Blind, Randomized, Placebo-Controlled, Multi-Centre, Dose-Ranging, Parallel Group, Phase II Study to Assess Efficacy, Safety/Tolerability, and Pharmacokinetics of a Thrombopoietin Receptor Agonist, SB-497115-GR, When Administered as 30, 50, and 75 mg Once Daily for 12 Weeks in Subjects With
1 other identifier
interventional
75
5 countries
30
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2005
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 13, 2005
CompletedFirst Posted
Study publicly available on registry
May 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedJune 4, 2012
March 1, 2011
1.5 years
May 13, 2005
May 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment response, assessed by the proportion of subjects with a shift from baseline platelet count (20, 000 to <70,000µL) to =100,000/µL after 4 weeks of study treatment.
4 weeks
Secondary Outcomes (1)
Mean increase in platelet counts and markers of thrombopoiesis. Safety and tolerability, population PK, pharmacodynamics. Effect of antiviral outcome measures during and after therapy.
4 weeks
Study Arms (4)
Arm B
ACTIVE COMPARATORSB-497115-GR 30mg 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.
Arm C
ACTIVE COMPARATORSB-497115-GR 50mg 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.
Arm D
ACTIVE COMPARATORSB-497115-GR 75mg 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.
Arm A
PLACEBO COMPARATORPlacebo 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.
Interventions
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.
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (30)
GSK Investigational Site
Denver, Colorado, 80262, United States
GSK Investigational Site
Boston, Massachusetts, 02215, United States
GSK Investigational Site
Detroit, Michigan, 48202, United States
GSK Investigational Site
St Louis, Missouri, 63104, United States
GSK Investigational Site
New York, New York, 10021, United States
GSK Investigational Site
Durham, North Carolina, 27710, United States
GSK Investigational Site
San Antonio, Texas, 78215, United States
GSK Investigational Site
Fairfax, Virginia, 22031, United States
GSK Investigational Site
Richmond, Virginia, 23249, United States
GSK Investigational Site
Clermont Ferrand Cédex 1, 63058, France
GSK Investigational Site
Clichy, 92118, France
GSK Investigational Site
Lyon, 69288, France
GSK Investigational Site
Lyon, 69437, France
GSK Investigational Site
Marseille, 13285, France
GSK Investigational Site
Nice, 06202, France
GSK Investigational Site
Paris, 75571, France
GSK Investigational Site
Pessac, 33604, France
GSK Investigational Site
Vandœuvre-lès-Nancy, 54511, France
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69120, Germany
GSK Investigational Site
Hamburg, Hamburg, 20246, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60590, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30625, Germany
GSK Investigational Site
Homburg, Saarland, 66421, Germany
GSK Investigational Site
Berlin, State of Berlin, 13353, Germany
GSK Investigational Site
San Juan, 00909-1711, Puerto Rico
GSK Investigational Site
Bristol, Gloucestershire, BS2 8HW, United Kingdom
GSK Investigational Site
Glasgow, Lanarkshire, G12 0YN, United Kingdom
GSK Investigational Site
Nottingham, Nottinghamshire, NG7 2UH, United Kingdom
GSK Investigational Site
London, NW3 2QG, United Kingdom
GSK Investigational Site
London, W2 1NY, United Kingdom
Related Publications (1)
McHutchison JG, Dusheiko G, Shiffman ML, Rodriguez-Torres M, Sigal S, Bourliere M, Berg T, Gordon SC, Campbell FM, Theodore D, Blackman N, Jenkins J, Afdhal NH; TPL102357 Study Group. Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C. N Engl J Med. 2007 Nov 29;357(22):2227-36. doi: 10.1056/NEJMoa073255.
PMID: 18046027BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2005
First Posted
May 16, 2005
Study Start
April 1, 2005
Primary Completion
October 1, 2006
Study Completion
November 1, 2006
Last Updated
June 4, 2012
Record last verified: 2011-03