Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assiut University
• Treatments: Azathioprine; Hydroxychloroquine; Vincristine

Criteria

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.