Clinical Trial: Evaluating the Safety and Efficacy of AMG531 in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura(ITP)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Dose-Finding Study Evaluating the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
Brief Summary: The purposes of this study are: to determine a weekly dose that demonstrates a satisfactory safety profile and sustains elevated platelet counts within a targeted therapeutic level (a doubling of baseline platelet counts and within the range of greater than or equal to 50 x 10^9/L and less than or equal to 450 x 10^9/L in thrombocytopenic subjects with ITP; to assess Amgen megakaryopoiesis protein 2 [AMP2 (AMG 531)] pharmacokinetics (PK) in thrombocytopenic subjects with ITP.
Detailed Summary:
Sponsor: Amgen
Current Primary Outcome: Incidence and severity of all adverse events and evaluation of antibody status
Original Primary Outcome:
Current Secondary Outcome:
- Proportion of subjects who achieve a platelet level (a doubling of baseline counts and within the range of greater than or equal to 50 x 10^9/L and less than or equal to 450 x 10^9/L)
- Duration within the targeted therapeutic platelet range
Original Secondary Outcome:
Information By: Amgen
Dates:
Date Received: May 20, 2005
Date Started:
Date Completion:
Last Updated: November 20, 2008
Last Verified: November 2008
