Clinical trial NCT03229746: Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia
Official title: Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Immune Thrombocytopenia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Platelet count
timeFrame: Follow up untill response or death from any cause up to six months
measure: side effects
timeFrame: Up to six months
Secondary outcomes:
measure: anti- nuclear antibodies role
timeFrame: before enrollment
measure: Anti-platelets antibodies role
timeFrame: after6 months
measure: Health quality life
timeFrame: after 6 months of treatment
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
References:
citation: Park YH, Yi HG, Lee MH, Kim CS, Lim JH. Clinical efficacy and tolerability of vincristine in splenectomized patients with refractory or relapsed immune thrombocytopenia: a retrospective single-center study. Int J Hematol. 2016 Feb;103(2):180-8. doi: 10.1007/s12185-015-1903-0. Epub 2015 Nov 20.
citation: Poudyal BS, Sapkota B, Shrestha GS, Thapalia S, Gyawali B, Tuladhar S. Safety and Efficacy of Azathioprine as a Second Line Therapy for Primary Immune Thrombocytopenic Purpura. JNMA J Nepal Med Assoc. 2016 Jul-Sep;55(203):16-21.
citation: Cooper N. State of the art - how I manage immune thrombocytopenia. Br J Haematol. 2017 Apr;177(1):39-54. doi: 10.1111/bjh.14515. Epub 2017 Mar 10.
citation: Michel M. Immune thrombocytopenic purpura: epidemiology and implications for patients. Eur J Haematol Suppl. 2009 Mar;(71):3-7. doi: 10.1111/j.1600-0609.2008.01206.x.
citation: Khellaf M, Chabrol A, Mahevas M, Roudot-Thoraval F, Limal N, Languille L, Bierling P, Michel M, Godeau B. Hydroxychloroquine is a good second-line treatment for adults with immune thrombocytopenia and positive antinuclear antibodies. Am J Hematol. 2014 Feb;89(2):194-8. doi: 10.1002/ajh.23609. Epub 2013 Nov 20.