Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia

Assiut University

Status and phase: Completed; Phase 4

Conditions: Immune Thrombocytopenia

Treatments: Drug: vincristine; Drug: Hydroxychloroquine; Drug: azathioprine

Study type: Interventional

Funder types: Other

Identifiers

NCT03229746

17200058

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

hydroxychloroquine group

Experimental group

Description:

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

Treatment:

Drug: Hydroxychloroquine

vincristine group

Active Comparator group

Description:

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

Treatment:

Drug: vincristine

azathioprine group

Active Comparator group

Description:

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

Treatment:

Drug: azathioprine