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

Systemic Lupus Erythematosus Clinical Trial

— HCQITP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549184
• Other study ID #: HCQITP
• Secondary ID: HCQ ITP
• Status: Completed
• Phase: N/A
• First received: March 6, 2012
• Last updated: March 20, 2012
• Start date: December 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: Henri Mondor University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Lupus Erythematosus, Systemic
• Purpura, Thrombocytopenic, Idiopathic
• Systemic Lupus Erythematosus
• Thrombocytopenia
• Thrombocytosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henri Mondor University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 to achieve a response, concomittant(s) treatment(s), need for an emergency treatment	one year	Yes
Secondary	Tolerance of Hydroxychloroquine	allergy, myopathy HCQ induced	one year	Yes