Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-06-01

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.

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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.

Conditions

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Immune Thrombocytopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hydroxychloroquine group

hydroxychloroquine tablets 200mg ,two times/day for at least 6 month

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

200mg twice daily orally for at least 12 weeks

vincristine group

vincristine ampoule , 1mg/ week, I.v drep over 2 hours for 4 weeks

Group Type ACTIVE_COMPARATOR

vincristine

Intervention Type DRUG

1mg intravenous weekly for 4 weeks

azathioprine group

azathioprine tablet 50mg, dose 100-150 mg daily for 6 month

Group Type ACTIVE_COMPARATOR

azathioprine

Intervention Type DRUG

dose 100mg daily for at least 3 weeks

Interventions

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Hydroxychloroquine

200mg twice daily orally for at least 12 weeks

Intervention Type DRUG

vincristine

1mg intravenous weekly for 4 weeks

Intervention Type DRUG

azathioprine

dose 100mg daily for at least 3 weeks

Intervention Type DRUG

Other Intervention Names

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imuran

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No