Immune ThrombocytopeniaITPNCT01869049
The Alteration of Macrophage Function in the Spleen Tissues From Patients With Primary Immune Thrombocytopenia
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 on the macrophage function in the spleen tissue of primary immune thrombocytopenia (ITP). Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Immune Thrombocytopenia
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Sep 2013
- 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chinese Adult with primary immune thrombocytopenia
Who may be able to join
- adult ITP patients whose platelet counts remain less than 10 x 10^9/L
- patients whose platelet counts remain less than 30 x 10^9/L and who continue to experience excessive bleeding after 4 to 6 weeks of appropriate medical treatment
- patients who have experienced a transient response to primary treatment and have platelet counts less than 30 x 10^9/L after 3 months
- require continuous glucocorticoid therapy to maintain safe platelet counts
- Willing and able to sign written informed consent.
Who cannot join
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
- Current HIV infection or hepatitis B virus or hepatitis C virus infections.
- Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
- Female patients who are pregnant.
- Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
- Patients who are deemed unsuitable for the study by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on the Alteration of Macrophage Function in the Spleen Tissue From Patients With Primary Immune Thrombocytopenia (ITP): a Multicenter, Perspective, Clinical Trial
This project was undertaken by Qilu Hospital of Shandong University and other well-known hospitals in China. In order to report the alteration on the macrophage function in the spleen tissue of primary immune thrombocytopenia (ITP).
- Conditions
- Immune Thrombocytopenia
- Keywords
- Immune Thrombocytopenia, macrophage, spleen tissue
- 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 accepted splenectomy | Not described | |
| Trauma with spleen rupture underwent splenectomy | 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)
CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L without recurrence of thrombocytopenia
Measured: The time frame is up to 3 months per subject
Evaluation of platelet response (R)
- A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia
Measured: The time frame is up to 3 months per subject
Evaluation of platelet response (No Response)
NR.No response (NR) was defined as 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 3 months per subject
Secondary outcomes (1)
Macrophage Function
Measure the platelet phagocytosis ability of macrophage in vitro
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startNov 2012
- Primary completionSep 2013 (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.
- 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
- Responsible party
- Principal investigator, Ming Hou, Shandong University
- Investigators
- Jun Peng, dr., Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869049
- Sponsor's protocol ID
- ITP-Spleen
- Other IDs
- 81070396
- Acronym
- ITP
- Status last verified
- Apr 2013
- First submitted
- 3 Apr 2013
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
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 Study on the Alteration of Macrophage Function in the Spleen Tissue From Patients With Primary Immune Thrombocytopenia (ITP): a Multicenter, Perspective, Clinical Trial
- ClinicalTrials.gov ID
- NCT01869049
- Acronym / sponsor ID
- ITP / ITP-Spleen
- Conditions
- Immune Thrombocytopenia
- Keywords
- Immune Thrombocytopenia, macrophage, spleen tissue
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No eligible patient was enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (estimated)
- First posted
- 5 Jun 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 on the macrophage function in the spleen tissue of primary immune thrombocytopenia (ITP).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ITP patients accepted splenectomy | – | – |
| Trauma with spleen rupture underwent splenectomy | – | – |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese Adult with primary immune thrombocytopenia
Key inclusion criteria (5 listed)
- adult ITP patients whose platelet counts remain less than 10 x 10^9/L
- patients whose platelet counts remain less than 30 x 10^9/L and who continue to experience excessive bleeding after 4 to 6 weeks of appropriate medical treatment
- patients who have experienced a transient response to primary treatment and have platelet counts less than 30 x 10^9/L after 3 months
- require continuous glucocorticoid therapy to maintain safe platelet counts
- Willing and able to sign written informed consent.
Key exclusion criteria (6 listed)
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
- Current HIV infection or hepatitis B virus or hepatitis C virus infections.
- Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
- Female patients who are pregnant.
- Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
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 3 months per subject
CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L without recurrence of thrombocytopenia
Evaluation of platelet response (R)
Time frame: The time frame is up to 3 months per subject
R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia
Evaluation of platelet response (No Response)
Time frame: The time frame is up to 3 months per subject
NR.No response (NR) was defined as 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
Macrophage Function
Time frame: two 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.
Related trials for Immune Thrombocytopenia
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RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
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RecruitingPhase 3
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
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RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
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RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
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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, dr. 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 5 inclusion and 6 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 3 months per subject). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.