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Status:

COMPLETED

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

Lead Sponsor:

GlaxoSmithKline

Conditions:

Hepatitis C, Chronic

Hepatitis C

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 fo...

Detailed Description

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 Ag...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • 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.
  • Exclusion criteria:
  • 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.

Exclusion

    Key Trial Info

    Start Date :

    April 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2006

    Estimated Enrollment :

    75 Patients enrolled

    Trial Details

    Trial ID

    NCT00110799

    Start Date

    April 1 2005

    End Date

    November 1 2006

    Last Update

    June 4 2012

    Active Locations (30)

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    Page 1 of 8 (30 locations)

    1

    GSK Investigational Site

    Denver, Colorado, United States, 80262

    2

    GSK Investigational Site

    Boston, Massachusetts, United States, 02215

    3

    GSK Investigational Site

    Detroit, Michigan, United States, 48202

    4

    GSK Investigational Site

    St Louis, Missouri, United States, 63104