Skip to main content
OpenTrials
Completed

NCT Number: NCT03229746

Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydroxychloroquine

Drug

200mg twice daily orally for at least 12 weeks

Vincristine

Drug

1mg intravenous weekly for 4 weeks

azathioprine

Drug

dose 100mg daily for at least 3 weeks

Other names: imuran

Primary outcomes

  1. Platelet count

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

    to detect response as the standard definition

  2. side effects

    Time frame: Up to six months

    any complication for any line of treatments line

Secondary outcomes

  1. anti- nuclear antibodies role

    Time frame: before enrollment

    Detecting the predictors for chronic ITP especially ANA role

  2. Anti-platelets antibodies role

    Time frame: after6 months

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

  3. 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 .

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 26, 2017
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.