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Retrospective Analysis of the Safety and Efficacy of Hydroxychloroquine in Immune Thrombocytopenia (HCQITP)

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ClinicalTrials.gov Identifier: NCT01549184
Recruitment Status : Completed
First Posted : March 9, 2012
Last Update Posted : March 21, 2012
Sponsor:
Information provided by (Responsible Party):
Khellaf Mehdi, Henri Mondor University Hospital

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

Condition or disease
Immune Thrombocytopenia Systemic Lupus Erythematosus

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 Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Analysis of the Safety and Efficacy of Hydroxychloroquine in Immune Thrombocytopenia Among 40 Patients
Study Start Date : December 2010
Primary Completion Date : December 2011
Study Completion Date : December 2011





Primary Outcome Measures :
  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 Frame: one year ]
    Time to achieve a response, concomittant(s) treatment(s), need for an emergency treatment


Secondary Outcome Measures :
  1. Tolerance of Hydroxychloroquine [ Time Frame: one year ]
    allergy, myopathy HCQ induced



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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).
Criteria

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...)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Khellaf Mehdi, Principal Investigator, Henri Mondor University Hospital
ClinicalTrials.gov Identifier: NCT01549184     History of Changes
Other Study ID Numbers: HCQITP
HCQ ITP ( Other Identifier: Referral center for autoimmune cytopenia among adults )
First Posted: March 9, 2012    Key Record Dates
Last Update Posted: March 21, 2012
Last Verified: March 2012

Keywords provided by Khellaf Mehdi, Henri Mondor University Hospital:
secondary ITP
hydroxychloroquine
Systemic Lupus Erythematosus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents