Alteration of Different Immune Parameters in Immune Thrombocytopenia （ITP） Patients Receiving Eltrombopag Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01864512|
Recruitment Status : Withdrawn (No eligible patient was enrolled.)
First Posted : May 29, 2013
Last Update Posted : April 20, 2016
|Condition or disease|
The primary objective of this study is to determine the efficacy of oral eltrombopag as a thrombopoietic agent treating previously treated chronic Chinese ITP patients and investigate the alteration of Different Immune Parameters after eltrombopag therapy.
Approximately 30 eligible subjects with primary ITP who have not responded to or have relapsed after previous treatment for ITP will be selected. The initial dose of eltrombopag administration is 25 mg orally once daily. During the 6 weeks follow-up, dose of investigational product will be adjusted according to the weekly subject platelet count, and a battery of immune parameters will be monitored at the end of each week. Additionally, the efficacy of oral eltrombopag for ITP will be assessed after 6 weeks administration.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||A Prospective, Multicenter Study on the Alteration of Different Immune Parameters in ITP Patients Receiving Eltrombopag Treatment.|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||April 2014|
|ITP patients receiving eltrombopag therapy|
- Evaluation of platelet response (Complete Response) [ Time Frame: The time frame is up to 6 weeks ]
- Complete response (CR)： A platelet count ≥ 100 * 10^9/L measured on two occasions > 7 days apart and the absence of bleeding.
- Response (R)： A platelet count ≥ 30 * 10^9/L and a greater than two fold increase in platelet count from baseline measured on two occasions > 7 days apart and the absence of bleeding.
- No response (NR)： A platelet count < 30 * 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.
- Alteration of Different Immune Parameters [ Time Frame: 6 weeks ]immune parameters,including expression of CD14,FcgammaRI,FcgammaRIIa/IIb and FcgammaRIII on monocyte/macrophages, will be determined once weekly till the end of the sixth week.
Biospecimen Retention: Samples With DNA
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): NCT01864512
|Qilu Hospital, Shandong University|
|Jinan, Shandong, China, 250012|
|Principal Investigator:||Jun Peng, Doctor||Qilu Hospital, Shandong University|