NCT01668615

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2012

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 20, 2012

Completed
Last Updated

October 23, 2012

Status Verified

October 1, 2012

Enrollment Period

1.6 years

First QC Date

July 30, 2012

Last Update Submit

October 21, 2012

Conditions

Immune Thrombocytopenic Purpura

Keywords

idiopathicthrombocytopenic purpuraall-trans retinoic acidregulory T cells

Interventions

all-trans-retinoid acidDRUG

10 mg three times a day oral administration for 4 months

Also known as: Tretinoin

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Other autoimmune diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Institute of Hematology

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Tretinoin

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Vitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Officials

  • zhaoyue wang, doctor

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jiangsu Institute of hematology

Study Record Dates

First Submitted

July 30, 2012

First Posted

August 20, 2012

Study Start

January 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 23, 2012

Record last verified: 2012-10

Locations

CN(1)