The Alteration of Macrophage Function in the Spleen Tissues From Patients With Primary Immune Thrombocytopenia

Withdrawn

• Conditions: Immune Thrombocytopenia

• Registration Number: NCT01869049
• Lead Sponsor: Shandong University

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 on the macrophage function in the spleen tissue of primary immune thrombocytopenia (ITP).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Status Verified: 2013-04
• Study First Submitted: 2013-04-03
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-06-05
• Primary Completion: 2013-09
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of platelet response (Complete Response)	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)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Macrophage Function	two weeks	Measure the platelet phagocytosis ability of macrophage in vitro

Trial Locations

Locations (1)

Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China