Assiut university hospital
Asyut, Egypt
NCT Number: NCT03229746
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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Notify Me18 year–70 year
All sexes
Interventional
Phase 4
Asyut, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
200mg twice daily orally for at least 12 weeks
1mg intravenous weekly for 4 weeks
dose 100mg daily for at least 3 weeks
Other names: imuran
Time frame: Follow up untill response or death from any cause up to six months
to detect response as the standard definition
Time frame: Up to six months
any complication for any line of treatments line
Time frame: before enrollment
Detecting the predictors for chronic ITP especially ANA role
Time frame: after6 months
Evaluation of the effect of the proposed drugs on the level of anti-platelet antibodies .
Time frame: 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 .
Assiut University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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