Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia
- Conditions
- Immune Thrombocytopenia
- Interventions
- Registration Number
- NCT03229746
- Lead Sponsor
- Assiut University
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description vincristine group vincristine vincristine ampoule , 1mg/ week, I.v drep over 2 hours for 4 weeks azathioprine group azathioprine azathioprine tablet 50mg, dose 100-150 mg daily for 6 month hydroxychloroquine group Hydroxychloroquine hydroxychloroquine tablets 200mg ,two times/day for at least 6 month
- Primary Outcome Measures
Name Time Method Platelet count Follow up untill response or death from any cause up to six months to detect response as the standard definition
side effects Up to six months any complication for any line of treatments line
- Secondary Outcome Measures
Name Time Method anti- nuclear antibodies role before enrollment Detecting the predictors for chronic ITP especially ANA role
Anti-platelets antibodies role after6 months Evaluation of the effect of the proposed drugs on the level of anti-platelet antibodies .
Health quality life after 6 months of treatment 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 .
Trial Locations
- Locations (1)
Assiut university hospital
🇪🇬Assiut, Egypt