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Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia

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ClinicalTrials.gov Identifier: NCT03229746
Recruitment Status : Completed
First Posted : July 26, 2017
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Ghada E. M. Abdallah, Assiut University

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.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: Hydroxychloroquine Drug: vincristine Drug: azathioprine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2018


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 Name: imuran




Primary Outcome Measures :
  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 Outcome Measures :
  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 .




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03229746


Locations
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Egypt
Assiut university hospital
Assiut, Egypt
Sponsors and Collaborators
Assiut University

Publications of Results:
Other Publications:
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Responsible Party: Ghada E. M. Abdallah, Principal investegator, Assiut University
ClinicalTrials.gov Identifier: NCT03229746     History of Changes
Other Study ID Numbers: 17200058
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Vincristine
Azathioprine
Hydroxychloroquine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Antirheumatic Agents