SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Refractory Immune Thrombocytopenic Purpura (ITP)
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|ClinicalTrials.gov Identifier: NCT00102739|
Recruitment Status : Completed
First Posted : February 2, 2005
Last Update Posted : April 15, 2013
|Condition or disease||Intervention/treatment||Phase|
|Purpura, Thrombocytopaenic, Idiopathic||Drug: SB497115||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||See Detailed Description|
|Study Start Date :||February 2005|
|Primary Completion Date :||January 2007|
|Study Completion Date :||January 2007|
- Treatment response, assessed by the proportion of patients with platelet counts of =50, 000/µL (compared with baseline count of <30, 000/µL) after 42 days of treatment.
- Safety, tolerability, PK, PD, symptoms associated with ITP, and QoL, odds of response vs placebo during weeks 2 to 6 of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102739
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|