Immune ThrombocytopeniaNCT01864512
Alteration of Different Immune Parameters in Immune Thrombocytopenia （ITP） Patients Receiving Eltrombopag Treatment
An observational study of Immune Thrombocytopenia, run by Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Immune Thrombocytopenia
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Subject is ≥18 years old.
- 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).
- 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.
- 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.
- Subjects treated with maintenance immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month.
- 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.
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- No history of clotting disorder, other than ITP.
- 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
- 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%.
- 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.
- -
Who cannot join
- 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).
- Any clinically relevant abnormality, other than ITP,which in the opinion of the investigator makes the subject unsuitable for participation in the study.
- Female subjects who are nursing or pregnant at screening or pre-dose on Day 1.
- History of alcohol/drug abuse or dependence within 12 months of the study.
- Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication.
- Subjects who have previously received eltrombopag therapy.
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- 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.
- Consumption of any herbal or dietary supplements, excluding vitamin or mineral supplements, within 1 week of the study start.
- History of platelet aggregation that prevents reliable measurement of platelet counts.
- 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.
- 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.
- Patients expected to require rescue on Day 1 of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter Study on the Alteration of Different Immune Parameters in ITP Patients Receiving Eltrombopag Treatment.
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.
Read the 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.
- Conditions
- Immune Thrombocytopenia
- Keywords
- Immune Thrombocytopenia, eltrombopag, immune regulation
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ITP patients receiving eltrombopag therapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of platelet response (Complete Response)
- 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.
Measured: The time frame is up to 6 weeks
Secondary outcomes (1)
Alteration of Different Immune Parameters
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2014 (estimated)
- Study completionApr 2014 (estimated)
Why it stopped: No eligible patient was enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences
- Responsible party
- Principal investigator, Ming Hou, Shandong University
- Investigators
- Jun Peng, Doctor, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864512
- Sponsor's protocol ID
- ITP-eltrombopag
- Status last verified
- Jun 2013
- First submitted
- 17 May 2013
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
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 Fcgamma 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.
PubMed 27281793
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study on the Alteration of Different Immune Parameters in ITP Patients Receiving Eltrombopag Treatment.
- ClinicalTrials.gov ID
- NCT01864512
- Acronym / sponsor ID
- ITP-eltrombopag
- Conditions
- Immune Thrombocytopenia
- Keywords
- Immune Thrombocytopenia, eltrombopag, immune regulation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No eligible patient was enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ITP patients receiving eltrombopag therapy | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- Subject is ≥18 years old.
- 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).
- 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.
- 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.
- Subjects treated with maintenance immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month.
Key exclusion criteria (12 listed)
- 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).
- Any clinically relevant abnormality, other than ITP,which in the opinion of the investigator makes the subject unsuitable for participation in the study.
- Female subjects who are nursing or pregnant at screening or pre-dose on Day 1.
- History of alcohol/drug abuse or dependence within 12 months of the study.
- Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Alteration of Different Immune Parameters
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
- Derived from this study: PubMed 27281793Liu 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 Fcgamma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Peng, Doctor principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Thrombocytopenia, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of platelet response (Complete Response) (time frame: The time frame is up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01864512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2016.