Retrospective Analysis of the Safety and Efficacy of Hydroxychloroquine in Immune Thrombocytopenia

NCT ID: NCT01549184

Last Updated: 2012-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-12-31

Brief Summary

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

Detailed Description

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Hydroxychloroquine (HCQ) is usually used in Patients with Systemic Lupus Erythematosus (SLE) in order to treat mainly arthralgia or skin manifestations of this disease. A few studies have previously shown that HCQ could also be useful for treating autoimmune cytopenia and particularly autoimmune thrombopenia associated with SLE. In this retrospective study, the investigators have selected patients followed in our center and who have received HCQ either for an authentic SLE or because they had positive antinuclear antibodies (\> 1/160e on HEP2 cells) without a definite SLE according to the American College of Rheumatology.

The main goal of this study is to compare the efficacy of HCQ in these two subgroups of patients.

Conditions

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Immune Thrombocytopenia Systemic Lupus Erythematosus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Secondary ITP (eg HIV, HCV, HBV, lymphoproliferative disorders...)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henri Mondor University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Khellaf Mehdi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 24254965 (View on PubMed)

Other Identifiers

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HCQ ITP

Identifier Type: OTHER

Identifier Source: secondary_id

HCQITP

Identifier Type: -

Identifier Source: org_study_id

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