- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01672151
Efficacy of Rapamycin Therapy With Chronic Immune Thrombocytopenia (ITP)
August 23, 2012 updated by: Zhaoyue Wang, First Affiliated Hospital of Suzhou Medical College
The aim of our study is to evaluate the efficacy of rapamycin with Refractory Immune Thrombocytopenic Purpura (RITP) and explore the further mechanism.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
35
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Suzhou, Jiangsu, China, 215006
- Jiangsu Institute of Hematology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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 .
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
August 17, 2012
First Submitted That Met QC Criteria
August 23, 2012
First Posted (Estimate)
August 24, 2012
Study Record Updates
Last Update Posted (Estimate)
August 24, 2012
Last Update Submitted That Met QC Criteria
August 23, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Skin Manifestations
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Purpura
- Purpura, Thrombocytopenic
- Purpura, Thrombocytopenic, Idiopathic
- Thrombocytopenia
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- jsxys456
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Immune Thrombocytopenic Purpura
-
argenxRecruitingIdiopathic Thrombocytopenic Purpura | Immune Thrombocytopenic Purpura | ITP | Immune Thrombocytopenia (ITP) | Idiopathic Thrombocytopenic Purpura (ITP) | Immune Thrombocytopenic Purpura ( ITP ) | ITP - Immune ThrombocytopeniaSpain, Romania, Poland, Germany, United Kingdom, Italy
-
Harbour BioMed (Guangzhou) Co. Ltd.CompletedPrimary Immune Thrombocytopenic PurpuraChina
-
Novartis PharmaceuticalsCompletedImmune Thrombocytopenic Purpura (ITP)Spain, Italy, Greece, Switzerland, United Kingdom, France, Turkey, Russian Federation, Brazil, Austria, Mexico, Oman, Chile, United States, Japan
-
Institute of Hematology & Blood Diseases Hospital...RecruitingPrimary Immune Thrombocytopenic PurpuraChina
-
Momenta Pharmaceuticals, Inc.TerminatedImmune Thrombocytopenic Purpura (ITP)United States, Poland, Hungary, Netherlands, Italy, Belgium, Spain
-
National Institute of Blood and Marrow Transplant...NovartisUnknownImmune Thrombocytopenic Purpura (ITP)Pakistan
-
Instituto Grifols, S.A.CompletedImmune (Idiopathic) Thrombocytopenic PurpuraSpain, Russian Federation, United Kingdom
-
Assiut UniversityNot yet recruitingPediatric Mmune Thrombocytopenic Purpura
-
AmgenCompletedThrombocytopenia | Immune Thrombocytopenia | Idiopathic Thrombocytopenic Purpura | Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Thrombocytopenic PurpuraUnited States, Canada, Australia
-
Neufeld, Ellis J, MD, PhDGenentech, Inc.; Biogen; Glaser Pediatric Research Network; Terrana ITP Research...CompletedImmune Thrombocytopenic Purpura (ITP) | Idiopathic Thrombocytopenic Purpura (ITP)United States
Clinical Trials on rapamycin
-
University Hospital, LilleMinistry of Health, FranceRecruitingPediatric | Lymphatic MalformationFrance
-
AFT Pharmaceuticals, Ltd.Not yet recruiting
-
Santen Inc.MacuSight, Inc.CompletedDiabetic Macular EdemaUnited States
-
Santen Inc.MacuSight, Inc.Completed
-
Christopher StrouseRecruitingMultiple MyelomaUnited States
-
Deutsches Herzzentrum MuenchenCompletedCoronary Heart DiseaseGermany
-
Johns Hopkins UniversityMacuSight, Inc.CompletedPanuveitis | Uveitis | Posterior Uveitis | Intermediate UveitisUnited States
-
Clinica Universidad de Navarra, Universidad de...Completed
-
National Cancer Institute (NCI)CompletedRecurrent Breast Carcinoma | Stage IV Breast Cancer AJCC v6 and v7 | Stage III Breast Cancer AJCC v7 | Stage IIIA Breast Cancer AJCC v7 | Stage IIIB Breast Cancer AJCC v7 | Stage IIIC Breast Cancer AJCC v7United States
-
National Cancer Institute (NCI)National Comprehensive Cancer NetworkCompletedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue SarcomaUnited States