NCT01672151

Brief Summary

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

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 Nov 2011

Shorter than P25 for all trials

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

November 1, 2011

Completed
9 months 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
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2012

Completed
Last Updated

August 24, 2012

Status Verified

August 1, 2012

Enrollment Period

9 months

First QC Date

August 17, 2012

Last Update Submit

August 23, 2012

Conditions

Immune Thrombocytopenic Purpura

Keywords

Refractory Immune Thrombocytopenic Purpurarapamycinregulatory T cells

Interventions

rapamycinDRUG

4mg oral administration on the first day, 2 mg/d oral administration for 3 months

Also known as: sirolimus

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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 .

You may qualify if:

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

You may not qualify if:

  • patients had a bad tolerance to rapamycin
  • platelet counts \< 10\*10E9/L during the treatment of rapamycin

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

Sirolimus

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)

MacrolidesLactonesOrganic Chemicals

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

August 17, 2012

First Posted

August 24, 2012

Study Start

November 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 24, 2012

Record last verified: 2012-08

Locations

CN(1)