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Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia

Primary Purpose

Immune Thrombocytopenia

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Hydroxychloroquine

vincristine

azathioprine

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Assiut university hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

hydroxychloroquine group

vincristine group

azathioprine group

Arm Description

hydroxychloroquine tablets 200mg ,two times/day for at least 6 month

vincristine ampoule , 1mg/ week, I.v drep over 2 hours for 4 weeks

azathioprine tablet 50mg, dose 100-150 mg daily for 6 month

Outcomes

Primary Outcome Measures

Platelet count

to detect response as the standard definition

side effects

any complication for any line of treatments line

Secondary Outcome Measures

anti- nuclear antibodies role

Detecting the predictors for chronic ITP especially ANA role

Anti-platelets antibodies role

Evaluation of the effect of the proposed drugs on the level of anti-platelet antibodies .

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 .

Full Information

NCT ID

NCT03229746

First Posted

July 23, 2017

Last Updated

June 27, 2018

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03229746

Brief Title

Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia

Official Title

Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

June 1, 2018 (Actual)

Study Completion Date

June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immune Thrombocytopenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

hydroxychloroquine group

Arm Type

Experimental

Arm Description

hydroxychloroquine tablets 200mg ,two times/day for at least 6 month

Arm Title

vincristine group

Arm Type

Active Comparator

Arm Description

vincristine ampoule , 1mg/ week, I.v drep over 2 hours for 4 weeks

Arm Title

azathioprine group

Arm Type

Active Comparator

Arm Description

azathioprine tablet 50mg, dose 100-150 mg daily for 6 month

Intervention Type

Drug

Intervention Name(s)

Hydroxychloroquine

Intervention Description

200mg twice daily orally for at least 12 weeks

Intervention Type

Drug

Intervention Name(s)

vincristine

Intervention Description

1mg intravenous weekly for 4 weeks

Intervention Type

Drug

Intervention Name(s)

azathioprine

Other Intervention Name(s)

imuran

Intervention Description

dose 100mg daily for at least 3 weeks

Primary Outcome Measure Information:

Title

Platelet count

Description

to detect response as the standard definition

Time Frame

Follow up untill response or death from any cause up to six months

Title

side effects

Description

any complication for any line of treatments line

Time Frame

Up to six months

Secondary Outcome Measure Information:

Title

anti- nuclear antibodies role

Description

Detecting the predictors for chronic ITP especially ANA role

Time Frame

before enrollment

Title

Anti-platelets antibodies role

Description

Evaluation of the effect of the proposed drugs on the level of anti-platelet antibodies .

Time Frame

after6 months

Title

Health quality life

Description

Time Frame

after 6 months of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Assiut university hospital

City

Assiut

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26588926

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.

Results Reference

background

PubMed Identifier

27935917

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.

Results Reference

background

PubMed Identifier

28295192

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. Erratum In: Br J Haematol. 2017 May;177(4):661.

Results Reference

background

PubMed Identifier

19200301

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.

Results Reference

background

PubMed Identifier

24254965

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.

Results Reference

result

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Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia

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