Therapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With Dexamethasone

NCT02914054 | Completed Phase 2

• 1 other identifier: IUMS
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective, randomized, controlled clinical trial investigators' aim was to compare the efficacy and the adverse effect of 3 therapy cycles of HD-DXM versus conventional treatment with PDN for untreated adult patients with ITP. In this study standardized criteria and definitions were used according to consensus international working group guideline for ITPto compare clinical outcomes of the two corticosteroid treatment regimens and determine the superior regimen as a first line strategy for new primary ITP in adults

Conditions

ITP; Croticosteroid Therapy

Keywords

ITP

Outcome Measures

Primary Outcomes (1)

• platelet count

  6-12 months

Study Arms (2)

Conventional Prednisone receiving group

ACTIVE COMPARATOR

Patients in PDN arm received PDN

Drug: Prednisone

Dxamethasone receiving group

ACTIVE COMPARATOR

In HD-DXM arm, DXM was administered

Drug: High dose Dexamethasone pulses

Interventions

High dose Dexamethasone pulses DRUG

In HD-DXM arm, DXM was administered intravenously at 40 mg in 500cc normal saline (0.9% saline) during 1 hour for consecutive 4 days and then stopped. This cycle was repeated in 14 days interval to receive 3 cycles of treatment.

Dxamethasone receiving group

Prednisone DRUG

Patients in PDN arm received PDN orally at 1.0 mg/kg body weight daily for 4 consecutive weeks. After achieving responses the medication tapered gradually to less than 15mg daily or terminated over 4-6 weeks aimed at maintaining platelet count over 30 ×109/L.

Conventional Prednisone receiving group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The eligible patients for this study were aged 18 or older of both genders with newly diagnosed primary ITP according to the international working group (IWG) guideline(6). All patients included in the study were treatment naïve ITP within 3 months from diagnosis and a platelet count of no more the 30×10\^9/L, or more than 30×10\^9/L with presence of bleeding symptoms according to the grading score of bleeding

You may not qualify if:

• malignancy, pregnancy or lactation, liver and kidney failure, connective tissue disorders, seropositive detection of HIV, hepatitis B virus or hepatitis C virus or any recent viral infection, active infection, diabetes, hypertension, cardiovascular disorders, autoimmune hemolytic anemia, psychosis, osteoporosis, any corticosteroid or immunosuppressive therapy in 3 months before diagnosis and any previous ITP-specific therapy.

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead
• Adibvira: collaborator

Study Sites (1)

IUMS

Isfahan, 8133946651, Iran

Location

Related Publications (6)

• McKenzie CG, Guo L, Freedman J, Semple JW. Cellular immune dysfunction in immune thrombocytopenia (ITP). Br J Haematol. 2013 Oct;163(1):10-23. doi: 10.1111/bjh.12480. Epub 2013 Aug 12.

  PMID: 23937260 BACKGROUND

• Neunert C, Lim W, Crowther M, Cohen A, Solberg L Jr, Crowther MA; American Society of Hematology. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood. 2011 Apr 21;117(16):4190-207. doi: 10.1182/blood-2010-08-302984. Epub 2011 Feb 16.

  PMID: 21325604 BACKGROUND

• Cheng Y, Wong RS, Soo YO, Chui CH, Lau FY, Chan NP, Wong WS, Cheng G. Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone. N Engl J Med. 2003 Aug 28;349(9):831-6. doi: 10.1056/NEJMoa030254.

  PMID: 12944568 BACKGROUND

• Wei Y, Ji XB, Wang YW, Wang JX, Yang EQ, Wang ZC, Sang YQ, Bi ZM, Ren CA, Zhou F, Liu GQ, Peng J, Hou M. High-dose dexamethasone vs prednisone for treatment of adult immune thrombocytopenia: a prospective multicenter randomized trial. Blood. 2016 Jan 21;127(3):296-302; quiz 370. doi: 10.1182/blood-2015-07-659656. Epub 2015 Oct 19.

  PMID: 26480931 BACKGROUND

• Mazzucconi MG, Fazi P, Bernasconi S, De Rossi G, Leone G, Gugliotta L, Vianelli N, Avvisati G, Rodeghiero F, Amendola A, Baronci C, Carbone C, Quattrin S, Fioritoni G, D'Alfonso G, Mandelli F; Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) Thrombocytopenia Working Party. Therapy with high-dose dexamethasone (HD-DXM) in previously untreated patients affected by idiopathic thrombocytopenic purpura: a GIMEMA experience. Blood. 2007 Feb 15;109(4):1401-7. doi: 10.1182/blood-2005-12-015222. Epub 2006 Oct 31.

  PMID: 17077333 BACKGROUND

• Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kuhne T, Ruggeri M, George JN. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009 Mar 12;113(11):2386-93. doi: 10.1182/blood-2008-07-162503. Epub 2008 Nov 12.

  PMID: 19005182 BACKGROUND

MeSH Terms

Interventions

Prednisone

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Internal Medicine, Clinical researcher, Professional Doctor of medicine

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 26, 2016
• Study Start: October 1, 2016
• Primary Completion: September 15, 2017
• Study Completion: September 15, 2017
• Last Updated: September 18, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share

Locations

IR (1)