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

Retrospective Analysis of the Safety and Efficacy of Hydroxychloroquine in Immune Thrombocytopenia Among 40 Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01549184

Acronym

HCQITP

Enrollment

Registered

2012-03-09

Start date

2010-12-31

Completion date

2011-12-31

Last updated

2012-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Thrombocytopenia, Systemic Lupus Erythematosus

Keywords

secondary ITP, hydroxychloroquine, Systemic Lupus Erythematosus

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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...)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Tolerance of Hydroxychloroquine	one year	allergy, myopathy HCQ induced

Outcome results