NCT01549184

Brief Summary

Retrospective study of the safety and efficacy of hydroxychloroquine among patients with immune Thrombopenia (ITP).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2010

Shorter than P25 for all trials

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

December 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
Last Updated

March 21, 2012

Status Verified

March 1, 2012

Enrollment Period

1 year

First QC Date

March 6, 2012

Last Update Submit

March 20, 2012

Conditions

Immune ThrombocytopeniaSystemic Lupus Erythematosus

Keywords

secondary ITPhydroxychloroquineSystemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

  • Number of patients achieving a response (Platelet count > 30x10^9/L and doubling of the baseline count) or a complete response (platelet count > 100x10^9/L for a t least 6 months)

    Time to achieve a response, concomittant(s) treatment(s), need for an emergency treatment

    one year

Secondary Outcomes (1)

  • Tolerance of Hydroxychloroquine

    one year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

40 patients with an immune thrombopenia with or without a definite SLE have been retrospectively studied. All the patients should have an ITP according to the ASH guidelines 2011 and have positive antinuclear antibodies (title \>1/160e on Hep2 cells).

You may qualify if:

  • Patients older than 18 years old
  • Immune Thrombopenia according to the American Society of Hematology (ASH) guidelines 2011
  • Positive antinuclear antibodies \> 1/160e on Hep2 cells

You may not qualify if:

  • Secondary ITP (eg HIV, HCV, HBV, lymphoproliferative disorders...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Khellaf M, Chabrol A, Mahevas M, Roudot-Thoraval F, Limal N, Languille L, Bierling P, Michel M, Godeau B. Hydroxychloroquine is a good second-line treatment for adults with immune thrombocytopenia and positive antinuclear antibodies. Am J Hematol. 2014 Feb;89(2):194-8. doi: 10.1002/ajh.23609. Epub 2013 Nov 20.

    PMID: 24254965DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, IdiopathicLupus Erythematosus, Systemic

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 SymptomsConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 9, 2012

Study Start

December 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 21, 2012

Record last verified: 2012-03