Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Khellaf Mehdi, Henri Mondor University Hospital
ClinicalTrials.gov Identifier:
NCT01549184
First received: March 6, 2012
Last updated: March 20, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by Henri Mondor University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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...)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Henri Mondor University Hospital

Additional 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
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
Autoimmune Diseases
Blood Platelet Disorders
Connective Tissue Diseases
Hematologic Diseases
Immune System Diseases
Hydroxychloroquine
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Antirheumatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014