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Efficacy of Immunomudulatory Therapy With All-trans Retinoid Acid for Adults 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:
NCT01668615
First received: July 30, 2012
Last updated: October 21, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to determine whether All-trans retinoic acid (ATRA) are effective in the treatment of refractory idiopathic thrombocytopenic purpura (RITP).


Condition Intervention
Immune Thrombocytopenic Purpura
 Drug: all-trans-retinoid acid

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Efficacy of Immunomudulatory Therapy With All-trans Retinoid Acid for Adults With Chronic Immune Thrombocytopenia

Resource links provided by NLM:

Drug Information available for: Tretinoin
U.S. FDA Resources

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

Enrollment: 35
Study Start Date: January 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: all-trans-retinoid acid
    10 mg three times a day oral administration for 4 months
    Other Name: Tretinoin
Detailed Description:

Idiopathic thrombocytopenic purpura(ITP), an acquired immune disease is characterized by impaired generation of autoantibody-specific platelet. At least 30% adult patients turn into refractory ITP. The pathogenesis of ITP remains to be elucidated. Now ,CD4+ helper cells have been classified as belong to T-helper 1(TH1), T-helper 2(TH2), T-helper17and Regulory T cell(Tregs). All-trans retinoic acid(ATRA) mainly applied in skin disease and acute promyelocytic leukemia. Recently, ATRA is also a immunomodulator which can induce differentiation, proliferation, apoptosis of cells, and immunomudulatory. In the international, the investigators first treat RITP with ATRA. To investigate the therapeutic effects of ATRA on RITP, and using new index in the cells, cytokines and molecular biology of three in-depth study of its mechanism.

  Eligibility

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

35 patients of RITP who do not response to prednisone,immunosuppressive agents and/or splenectomy were observed in our study .

Criteria

Inclusion Criteria:

  • Clinical diagnosis of refratory idiopathic thrombocytopenic purpura
  • Hormone and immune suppression, splenectomy is invalid

Exclusion Criteria:

  • Other autoimmune diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668615

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: NCT01668615     History of Changes
Other Study ID Numbers: jsxys-123
Study First Received: July 30, 2012
Last Updated: October 21, 2012
Health Authority: China: National Natural Science Foundation

Keywords provided by First Affiliated Hospital of Suzhou Medical College:
idiopathicthrombocytopenic purpura
all-trans retinoic acid
regulory 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
Tretinoin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 16, 2013