Clinical Trial: Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP) -A Multicenter Study in Subjects With Chronic ITP Receiving a Double-Blind, Placeb

Brief Summary: This is a Phase II/III multicenter study comprising of the double-blind, followed by open-label phases to evaluate and compare the efficacy and tolerability of eltrombopag (SB-497115-GR) in chronic ITP patients

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Number of Responders at Week 6 [ Time Frame: Week 6 ]
    A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter).
  • Percentage of Participants for Whom at Least 75% of Their Assessments During the Course of 26 Weeks of SB-497115-GR Treatment Met the Definition of Responders [ Time Frame: Week 26 ]
    A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.


Original Primary Outcome: Efficacy - The proportion of subjects achieving a platelet count(50,000/uL to 400,000/uL)after 6 weeks of study medication - The percentage of assessment visits during 26 weeks of each subject achieving the platelet count [ Time Frame: percentage of assessment visits during 26 weeks of each subject achiving the platelet count ]

Current Secondary Outcome:

  • Number of Participants Assessed as Responders in at Least 4 Assessments Between Weeks 2 and 6 [ Time Frame: Weeks 2 through 6 ]
    A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter) at at least 4 out of 5 scheduled visits.
  • Percentage of Responders at Each Visit [ Time Frame: Days 8, 15, 22, 29, 36, and 43 ]
    A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter).
  • Mean Platelet Count at Each Visit [ Time Frame: Baseline and Days 8, 15, 22, 29, 36, and 43 ]
    Blood taken from peripheral blood vessels was used for the measurement of platelet counts.
  • Mean Change From Baseline in Platelet Counts at Each Visit [ Time Frame: Baseline and Days 8, 15, 22, 29, 36, and 43 ]
    Change from baseline was calculated as values at Days 8, 15, 22, 29, 36, and 43 minus baseline value
  • Percentage of Participants With Bleeding Episodes Since the Last Visit [ Time Frame: Days 1, 8, 15, 22, 29, 36, and 43 ]
    When abnormal bleeding(s) was found since the last visit, it was recorded as a bleeding episode(s).
  • Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category [ Time Frame: Baseline and Days 8, 15, 22, 29, 36, and 43 ]
    Blood taken from peripheral blood vessels was used for the measurement of platelet counts.
  • Percentage of Responders at Each Visit [ Time Frame: Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26 ]
    A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.
  • Mean Platelet Counts of Participants at Each Visit [ Time Frame: Baseline; Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26 ]
    Blood taken from peripheral blood vessels was used for the measurement of platelet counts. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.
  • Mean Change From Baseline in Platelet Counts at Each Visit [ Time Frame: Baseline; Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26 ]
    Change from baseline was calculated as values at Days 8, 15, 22, 29, 36, and 43 and Weeks 10, 14, 18, 22, and 26 minus baseline value. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.
  • Mean Maximum Duration for Which Participants Maintained Platelet Counts >=50 x 10^9/Liter and <=400 x 10^9/Liter [ Time Frame: Weeks 1 through 26 ]
    Maximum duration is measured as the longest period (days) for which a participant continuously maintained platelet counts within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.
  • Mean Total Time for Which Participants Maintained Platelet Counts >=50 x 10^9/Liter and <=400 x 10^9/Liter [ Time Frame: Weeks 1 through 26 ]
    Total time is measured as the cumulative number of days over which platelet counts were maintained within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the

    Original Secondary Outcome: - Reduction of concomitant medication - Safety and tolerability - Pharmacokinetics and pharmacodynamics (platelet count) [ Time Frame: percentage of assessment visits during 26 weeks of each subject achiving the platelet count ]

    Information By: GlaxoSmithKline

    Dates:
    Date Received: October 5, 2007
    Date Started: September 2007
    Date Completion:
    Last Updated: March 29, 2011
    Last Verified: March 2011