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

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

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Key information

Conditions

Immune Thrombocytopenia Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Connective Tissue Diseases Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Lupus Erythematosus, Systemic Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Skin and Connective Tissue Diseases Systemic Lupus Erythematosus Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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...)

Treatment and study plan

Primary outcomes

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 frame: one year

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

Secondary outcomes

Tolerance of Hydroxychloroquine

Time frame: one year

allergy, myopathy HCQ induced

Sponsors and collaborators

Lead sponsor

Henri Mondor University Hospital

Other

Registry information

Official study title

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

Acronym: HCQITP

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Mar 9, 2012
Registry last updated: Mar 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting