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Alteration of Different Immune Parameters in Immune Thrombocytopenia (ITP) Patients Receiving Eltrombopag Treatment

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ClinicalTrials.gov Identifier: NCT01864512
Recruitment Status : Withdrawn (No eligible patient was enrolled.)
First Posted : May 29, 2013
Last Update Posted : April 20, 2016
Sponsor:
Collaborator:
Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Ming Hou, Shandong University

Tracking Information
First Submitted Date May 17, 2013
First Posted Date May 29, 2013
Last Update Posted Date April 20, 2016
Study Start Date March 2013
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 24, 2013)
Evaluation of platelet response (Complete Response) [ Time Frame: The time frame is up to 6 weeks ]
  1. Complete response (CR): A platelet count ≥ 100 * 10^9/L measured on two occasions > 7 days apart and the absence of bleeding.
  2. 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.
  3. 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01864512 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 24, 2013)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Alteration of Different Immune Parameters in Immune Thrombocytopenia (ITP) Patients Receiving Eltrombopag Treatment
Official Title A Prospective, Multicenter Study on the Alteration of Different Immune Parameters in ITP Patients Receiving Eltrombopag Treatment.
Brief Summary This project was undertaken by Qilu Hospital of Shandong University and other well-known hospitals in China. In order to report the alteration of Different Immune Parameters in ITP Patients Receiving Eltrombopag Treatment.
Detailed Description

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
The biospecimens were retained for PCR, western blotting and FACS analysis.
Sampling Method Probability Sample
Study Population Chinese chronic primary immune thrombocytopenia (ITP) adult subjects who have not responded to or have relapsed after previous treatment for ITP, including first line therapy and /or splenectomy.
Condition Immune Thrombocytopenia
Intervention Not Provided
Study Groups/Cohorts ITP patients receiving eltrombopag therapy
Publications * Liu XG, Liu S, Feng Q, Liu XN, Li GS, Sheng Z, Chen P, Liu Y, Wei Y, Dong XY, Qin P, Gao C, Ma C, Zhang L, Hou M, Peng J. Thrombopoietin receptor agonists shift the balance of Fcγ receptors toward inhibitory receptor IIb on monocytes in ITP. Blood. 2016 Aug 11;128(6):852-61. doi: 10.1182/blood-2016-01-690727. Epub 2016 Jun 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: April 18, 2016)
0
Original Estimated Enrollment
 (submitted: May 24, 2013)
30
Estimated Study Completion Date April 2014
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Subject is ≥18 years old.
  2. Diagnosed with ITP for at least 12 months prior to screening, and have a platelet count of <30 X109/L on Day 1 (or within 48 hours prior to dosing on Day 1).
  3. Patients who have no response or relapsed after splenectomy. Or patients who have not been splenectomised and have either not responded to one or more prior therapies (except splenectomy), or who have relapsed prior therapy.
  4. Previous therapy for ITP including rescue must have been completed at least 2 weeks prior to randomization, and other TPO-R agonists, such as romiplostim or recombinant human thrombopoietin (rhTPO), must have been completed for more than 30 days before enrollment.
  5. Subjects treated with maintenance immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month.
  6. No pre-existing cardiac disease within the last 3 months. No arrhythmia known to increase the risk of thrombolic events (e.g. atrial fibrillation), or patients with a Corrected QT interval (QTc) >450msec or QTc >480 for patients with a Bundle Branch Block.
  7. No history of clotting disorder, other than ITP.
  8. A complete blood count (CBC), within the reference range, with the following exceptions:

    • Platelets <30×109/L on Day 1 (or within 48hours of Day 1) is required for inclusion,
    • Hemoglobin: females and males 10.0 g/dl are eligible for inclusion,
    • Absolute neutrophil count (ANC) ≥1500/µL (1.5×109/L) is required for inclusion
  9. Blood chemistry test result no exceed normal by more than 20%. Total albumin must not be below the lower limit of normal (LLN) by more than 10%.
  10. Subject is non-childbearing potential of childbearing potential and use acceptable methods of contraception from two weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study.

    -

Exclusion Criteria:

  1. Patients with any prior history of arterial or venous thrombosis, AND ≥ two of the following risk factors: hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension, cancer, hereditary thrombophilic disorders (e.g., Factor V Leiden, ATIII deficiency, antiphospholipid syndrome, etc).
  2. Any clinically relevant abnormality, other than ITP,which in the opinion of the investigator makes the subject unsuitable for participation in the study.
  3. Female subjects who are nursing or pregnant at screening or pre-dose on Day 1.
  4. History of alcohol/drug abuse or dependence within 12 months of the study.
  5. Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication.
  6. Subjects who have previously received eltrombopag therapy.
  7. Subject has consumed aspirin, aspirin-containing compounds, salicylates, anticoagulants, quinine or non-steroidal anti-inflammatories (NSAIDs) for >3 consecutive days within 2 weeks of the study start and until the end of the study.
  8. Consumption of any herbal or dietary supplements, excluding vitamin or mineral supplements, within 1 week of the study start.
  9. History of platelet aggregation that prevents reliable measurement of platelet counts.
  10. An abnormality in bone marrow examination result, other than ITP, identified on the screening examination, which in the opinion of the investigator makes the subject unsuitable for participation in the study.
  11. Any laboratory or clinical evidence for HIV infection; any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subject screening. Laboratory test at screening show evidence for hepatitis C infection or hepatitis B infection.
  12. Patients expected to require rescue on Day 1 of the study.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01864512
Other Study ID Numbers ITP-eltrombopag
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ming Hou, Shandong University
Study Sponsor Shandong University
Collaborators Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Jun Peng, Doctor Qilu Hospital, Shandong University
PRS Account Shandong University
Verification Date June 2013