Immune Thrombocytopenia
Conditions
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.
Interventions
DRUGHydroxychloroquine
200mg twice daily orally for at least 12 weeks
DRUGvincristine
1mg intravenous weekly for 4 weeks
DRUGazathioprine
dose 100mg daily for at least 3 weeks
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 . |
Countries
Egypt
Outcome results
None listed