Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia

June 27, 2018 updated by: Ghada E. M. Abdallah, Assiut University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hydroxychloroquine group
hydroxychloroquine tablets 200mg ,two times/day for at least 6 month
Drug: Hydroxychloroquine
200mg twice daily orally for at least 12 weeks
Active Comparator: vincristine group
vincristine ampoule , 1mg/ week, I.v drep over 2 hours for 4 weeks
Drug: vincristine
1mg intravenous weekly for 4 weeks
Active Comparator: azathioprine group
azathioprine tablet 50mg, dose 100-150 mg daily for 6 month
Drug: azathioprine
dose 100mg daily for at least 3 weeks
Other Names:
  • imuran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet count
Time Frame: Follow up untill response or death from any cause up to six months
to detect response as the standard definition
Follow up untill response or death from any cause up to six months
side effects
Time Frame: Up to six months
any complication for any line of treatments line
Up to six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anti- nuclear antibodies role
Time Frame: before enrollment
Detecting the predictors for chronic ITP especially ANA role
before enrollment
Anti-platelets antibodies role
Time Frame: after6 months
Evaluation of the effect of the proposed drugs on the level of anti-platelet antibodies .
after6 months
Health quality life
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 .
after 6 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

July 23, 2017

First Submitted That Met QC Criteria

July 24, 2017

First Posted (Actual)

July 26, 2017

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17200058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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