Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia

NCT03229746 | Completed Phase 4 DMC

• 1 other identifier: 17200058
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (2)

• Platelet count

  to detect response as the standard definition

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

• side effects

  any complication for any line of treatments line

  Up to six months

Secondary Outcomes (3)

• anti- nuclear antibodies role

  before enrollment

• Anti-platelets antibodies role

  after6 months

• Health quality life

  after 6 months of treatment

Study Arms (3)

hydroxychloroquine group

EXPERIMENTAL

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

Drug: Hydroxychloroquine

vincristine group

ACTIVE COMPARATOR

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

Drug: vincristine

azathioprine group

ACTIVE COMPARATOR

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

Drug: azathioprine

Interventions

Hydroxychloroquine DRUG

200mg twice daily orally for at least 12 weeks

hydroxychloroquine group

vincristine DRUG

1mg intravenous weekly for 4 weeks

vincristine group

azathioprine DRUG

dose 100mg daily for at least 3 weeks

Also known as: imuran

azathioprine group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, Egypt

Location

Related Publications (5)

• 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.

  PMID: 26588926 BACKGROUND

• 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.

  PMID: 27935917 BACKGROUND

• 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.

  PMID: 28295192 BACKGROUND

• 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.

  PMID: 19200301 BACKGROUND

• 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.

  PMID: 24254965 RESULT

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Hydroxychloroquine; Vincristine; Azathioprine

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investegator

Study Record Dates

• First Submitted: July 23, 2017
• First Posted: July 26, 2017
• Study Start: August 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 28, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)