Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia

Immune Thrombocytopenia Clinical Trial

Official title:

Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03229746
• Other study ID #: 17200058
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: June 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• Hydroxychloroquine
200mg twice daily orally for at least 12 weeks
• vincristine
1mg intravenous weekly for 4 weeks
• azathioprine
dose 100mg daily for at least 3 weeks

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. Review. Erratum in: Br J Haematol. 2017 May;177(4):661. — View 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 Fe — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet count	to detect response as the standard definition	Follow up untill response or death from any cause up to six months
Primary	side effects	any complication for any line of treatments line	Up to six months
Secondary	anti- nuclear antibodies role	Detecting the predictors for chronic ITP especially ANA role	before enrollment
Secondary	Anti-platelets antibodies role	Evaluation of the effect of the proposed drugs on the level of anti-platelet antibodies .	after6 months
Secondary	Health quality life	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 .	after 6 months of treatment