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

Completed

• Conditions: Immune Thrombocytopenia; Systemic Lupus Erythematosus

• Registration Number: NCT01549184
• Lead Sponsor: Henri Mondor University Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-03
• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-03-08
• Study First Posted: 2012-03-09
• Last Update Submitted: 2012-03-20
• Last Update Posted: 2012-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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...)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	one year	Time to achieve a response, concomittant(s) treatment(s), need for an emergency treatment

Secondary Outcome Measures

Name	Time	Method
Tolerance of Hydroxychloroquine	one year	allergy, myopathy HCQ induced