Efficacy of Rapamycin Therapy With Chronic Immune Thrombocytopenia (ITP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhaoyue Wang, First Affiliated Hospital of Suzhou Medical College
ClinicalTrials.gov Identifier:
NCT01672151
First received: August 17, 2012
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention
Immune Thrombocytopenic Purpura
Drug: rapamycin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Efficacy of Rapamycin Therapy With Chronic Immune Thrombocytopenia

Resource links provided by NLM:


Further study details as provided by First Affiliated Hospital of Suzhou Medical College:

Enrollment: 35
Study Start Date: November 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: rapamycin
    4mg oral administration on the first day, 2 mg/d oral administration for 3 months
    Other Name: sirolimus
Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

35 patients using rapamycin therapy were observed before and after treatment,who did not response to any other administrations including prednisone and immunosuppressive drugs, even splenectomy .

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01672151

Locations
China, Jiangsu
Jiangsu Institute of Hematology
Suzhou, Jiangsu, China, 215006
Sponsors and Collaborators
First Affiliated Hospital of Suzhou Medical College
Investigators
Study Director: zhaoyue wang, doctor
  More Information

No publications provided

Responsible Party: Zhaoyue Wang, Jiangsu Institute of hematology, First Affiliated Hospital of Suzhou Medical College
ClinicalTrials.gov Identifier: NCT01672151     History of Changes
Other Study ID Numbers: jsxys456
Study First Received: August 17, 2012
Last Updated: August 23, 2012
Health Authority: China: National Natural Science Foundation

Keywords provided by First Affiliated Hospital of Suzhou Medical College:
Refractory Immune Thrombocytopenic Purpura
rapamycin
regulatory T cells

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014