Retrospective Analysis of the Safety and Efficacy of Hydroxychloroquine in Immune Thrombocytopenia (HCQITP)
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Purpose
Retrospective study of the safety and efficacy of hydroxychloroquine among patients with immune Thrombopenia (ITP).
| Condition |
|---|
|
Immune Thrombocytopenia Systemic Lupus Erythematosus |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Retrospective Analysis of the Safety and Efficacy of Hydroxychloroquine in Immune Thrombocytopenia Among 40 Patients |
- 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 ] [ Designated as safety issue: Yes ]Time to achieve a response, concomittant(s) treatment(s), need for an emergency treatment
- Tolerance of Hydroxychloroquine [ Time Frame: one year ] [ Designated as safety issue: Yes ]allergy, myopathy HCQ induced
| Enrollment: | 40 |
| Study Start Date: | December 2010 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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).
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...)
Contacts and Locations More Information
No publications provided
| Responsible Party: | Khellaf Mehdi, Principal Investigator, Henri Mondor University Hospital |
| ClinicalTrials.gov Identifier: | NCT01549184 History of Changes |
| Other Study ID Numbers: | HCQITP, HCQ ITP |
| Study First Received: | March 6, 2012 |
| Last Updated: | March 20, 2012 |
| Health Authority: | France: Committee for the Protection of Personnes |
Keywords provided by Henri Mondor University Hospital:
|
secondary ITP hydroxychloroquine Systemic Lupus Erythematosus |
Additional relevant MeSH terms:
|
Lupus Erythematosus, Systemic Thrombocytopenia Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Blood Platelet Disorders Hematologic Diseases Hydroxychloroquine Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 19, 2013