Efficacy of Rapamycin Therapy With Chronic Immune Thrombocytopenia

Immune Thrombocytopenic Purpura Clinical Trial

— ITP  

Official title:

Efficacy of Rapamycin Therapy With Chronic Immune Thrombocytopenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01672151
• Other study ID #: jsxys456
• Status: Completed
• Phase: N/A
• First received: August 17, 2012
• Last updated: August 23, 2012
• Start date: November 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: First Affiliated Hospital of Suzhou Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational

Clinical Trial Summary

The aim of our study is to evaluate the efficacy of rapamycin with Refractory Immune Thrombocytopenic Purpura (RITP) and explore the further mechanism.

Description:

Rapamycin, an immunosuppressive drug, is widely used to prevent allograft rejection and autoimmune diseases. Many studies have shown that the drug contributes to the expansion of regulatory T cells and preserves the highly suppressive function of autoreactive T cells. Patients with RITP often display a decreased proportion of regulatory T cells by flow cytometer, therefore, the investigators will examine the efficacy of rapamycin in RITP patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical diagnoses of idiopathic thrombocytopenic purpura

• Hormone and immune suppression, splenectomy is invalid

Exclusion Criteria:

• patients had a bad tolerance to rapamycin

• platelet counts < 10*10E9/L during the treatment of rapamycin

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Drug:
• rapamycin
4mg oral administration on the first day, 2 mg/d oral administration for 3 months

Locations

Country	Name	City	State
China	Jiangsu Institute of Hematology	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Suzhou Medical College

Country where clinical trial is conducted

China,