Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia

Last updated: June 27, 2018
Sponsor: Assiut University
Overall Status: Completed

Phase

4

Condition

Platelet Disorders

Immune (Idiopathic) Thrombocytopenic Purpura (Itp)

Thrombocytopenia And Thrombocytopenia Prevention

Treatment

N/A

Clinical Study ID

NCT03229746
17200058
  • Ages 18-70
  • All Genders

Study Summary

Hydroxychloroquine has been reported to have a clinically significant effect on the platelet count in systemic lupus thrombocytopenia. Its action may be due to its immune modulator effect. Immune thrombocytopenia (ITP) is known as an immune-mediated acquired disease characterized by transient or persistent decrease of the platelet count. However, refractory ITP is lacking of effective treatments and the efficacy of decitabine in ITP remains poorly understood. Data from this study may provide some idea of Hydroxychloroquine in the treatment of ITP in comparison to other lines of treatment as detected by the standardized definitions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • We will recruit patients with primary chronic ITP patients with ITP lasting for morethan 12 months which is proved to be refractory to the standard first line treatmentor need to treatment(s) (including, but not limited to, low dose of corticosteroids)to minimize the risk of clinically significant bleeding.

  • Subject or their guardian has signed and dated a written informed consent.

  • Subject experienced no toxicity or known contraindication to any line of treatments.

Exclusion

Exclusion Criteria:

  • pregnancy.

  • liver and kidney function impairment.

  • hepatitis c virus(HCV), human immunodeficiency virus (HIV), hepatitis B virusinfection.

  • patients with systemic lupus erythematosus and/or antiphospholipid syndrome

  • lymphoproliferative disorders.

  • an active malignancy

  • an arterial or venous thrombosis

  • Grade III-IV cardiovascular disease .

  • Recent history of alcohol/drug abuse.

  • Subjects recently treated with drugs that affect platelet function (including but notlimited to aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for > 3 consecutivedays within 2 weeks of the study start and until the end of the study.

Study Design

Total Participants: 40
Study Start date:
August 01, 2017
Estimated Completion Date:
June 01, 2018

Study Description

This study will include patients with chronic ITP attending the out patients clinic of Clinical Hematology Unit of Internal Medicine Department of Assiut university Hospital to evaluate the safety and efficacy of hydroxychloroquine in comparison to other lines of treatment as detected by the standardized definitions . Detect the predictors for chronic ITP especially anti-nuclear antibodies (ANA) role and the effect of the proposed drugs on the level of anti-platelet antibodies. Evaluation of the health-related quality of life after treatments to answer this question; Is the most effective drug is linked to the best quality of life.

Connect with a study center

  • Assiut university hospital

    Assiut,
    Egypt

    Site Not Available

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