Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia

Conditions
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Immune Thrombocytopenia

Intervention / Treatment
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* Drug: Hydroxychloroquine
* Drug: vincristine
* Drug: azathioprine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: We will recruit patients with primary chronic ITP patients with ITP lasting for more than 12 months which is proved to be refractory to the standard first line treatment or 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 Criteria: pregnancy. liver and kidney function impairment. hepatitis c virus(HCV), human immunodeficiency virus (HIV), hepatitis B virus infection. 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 not limited to aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for > 3 consecutive days within 2 weeks of the study start and until the end of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hydroxychloroquine group<br>hydroxychloroquine tablets 200mg ,two times/day for at least 6 month | Drug: Hydroxychloroquine<br>* 200mg twice daily orally for at least 12 weeks<br>|
| Active Comparator: vincristine group<br>vincristine ampoule , 1mg/ week, I.v drep over 2 hours for 4 weeks | Drug: vincristine<br>* 1mg intravenous weekly for 4 weeks<br>|
| Active Comparator: azathioprine group<br>azathioprine tablet 50mg, dose 100-150 mg daily for 6 month | Drug: azathioprine<br>* dose 100mg daily for at least 3 weeks<br>* Other names: imuran;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet count | to detect response as the standard definition | Follow up untill response or death from any cause up to six months | 
| side effects | any complication for any line of treatments line | Up to six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti- nuclear antibodies role | Detecting the predictors for chronic ITP especially ANA role | before enrollment | 
| Anti-platelets antibodies role | Evaluation of the effect of the proposed drugs on the level of anti-platelet antibodies . | after6 months | 
| Health quality life | The Arabic version of the 36-Item Short Form Survey Instrument (SF-36) questionnaire will be administered to all patients before & after treatment. This questionnaire is a validated one which assesses general health functioning . | after 6 months of treatment |