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

Immune Thrombocytopenia Clinical Trial

— ITP  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01869049
• Other study ID #: ITP-Spleen
• Secondary ID: 81070396
• Status: Withdrawn
• Phase: N/A
• First received: April 3, 2013
• Last updated: April 18, 2016
• Start date: November 2012

Study information

• Verified date: April 2013
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia
• Thrombocytosis

Locations

Country	Name	City	State
China	Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The time frame is up to 3 months per subject	Yes
Primary	Evaluation of platelet response (R)	R. A response (R) was defined as a sustained (= 3 months) platelet count = 30×10^9/L without recurrence of thrombocytopenia	The time frame is up to 3 months per subject	Yes
Primary	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.	The time frame is up to 3 months per subject	Yes
Secondary	Macrophage Function	Measure the platelet phagocytosis ability of macrophage in vitro	two weeks	No