Therapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With Dexamethasone

Sponsor

Isfahan University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT02914054

Collaborator

Adibvira (Other)

Enrollment

Location

Arms

11.5

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
ITP Croticosteroid Therapy	Drug: High dose Dexamethasone pulses Drug: Prednisone	Phase 2/Phase 3

Detailed Description

Therapy of Adults affected by idiopathic thrombocytopenic purpura with 3 cycles pulses of high-dose dexamethasone (HD-DXM): a prospective randomized clinical trial Alireza Sadeghi, Saeid Rezaei Jouzdani, Forough Hosseini

Introduction :

Idiopathic thrombocytopenic purpura(ITP) is an autoimmune disorder characterized by platelet destruction leading to decreased platelet count and an increased risk of bleeding. Mechanisms including autoantibody- mediated platelet destruction, cytotoxic T-lymphocyte platelet lysis, impaired platelet maturation and production has been identified in the pathogenesis of ITP.(1)The first line treatment of ITP is still corticosteroid therapy. Prednisone(PDN) is the standard corticosteroid therapy in ITP practical guideline usually given at 1 mg/kg per day for 4 weeks and then tapered.(2) Recent studies suggested pulsed high-dose dexamethasone given at a dose 40 mg/day to a 4-day course treatment as an alternative corticosteroid instead of prednisone to reduce the duration and the adverse effect of corticosteroid therapy.(3-5) A multicenter randomized clinical trial compared the 2 corticosteroid therapy and suggested that HD-DXM has more effective and better tolerance than PDN.(4) Another multicenter cohort study using repeated courses of HD-DXM (from 6 to 4 cycles, repeated each cycle 28 days to 14 days interval) confirmed the benefit as compared with conventional therapy and proposed as a first-line treatment for patients with ITP. Also there was no difference in overall response rate between the third and the fourth cycles of HD-DXM pulses therapy, using 3 therapy cycles with 14 days interval between each cycle, has been proposed for better safety and efficacy.(5) 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 ITP(6) to 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Therapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With 3 Cycles Pulses of High-dose Dexamethasone (HD-DXM)

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Sep 15, 2017

Actual Study Completion Date :

Sep 15, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional Prednisone receiving group Patients in PDN arm received PDN	Drug: Prednisone 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.
Active Comparator: Dxamethasone receiving group In HD-DXM arm, DXM was administered	Drug: High dose Dexamethasone pulses 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.

Arm

Intervention/Treatment

Active Comparator: Conventional Prednisone receiving group

Patients in PDN arm received PDN

Drug: Prednisone

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.

Active Comparator: Dxamethasone receiving group

In HD-DXM arm, DXM was administered

Drug: High dose Dexamethasone pulses

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.

Outcome Measures

Primary Outcome Measures

platelet count [6-12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IUMS	Isfahan		Iran, Islamic Republic of	8133946651

Sponsors and Collaborators

Isfahan University of Medical Sciences
Adibvira

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Saeid Rezaei Jouzdani, Resident of Internal Medicine, Clinical researcher, Professional Doctor of medicine, Isfahan University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT02914054

Other Study ID Numbers:

IUMS

First Posted:

Sep 26, 2016

Last Update Posted:

Sep 18, 2017

Last Verified:

Sep 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by Saeid Rezaei Jouzdani, Resident of Internal Medicine, Clinical researcher, Professional Doctor of medicine, Isfahan University of Medical Sciences

ITP

Additional relevant MeSH terms:

Purpura

Purpura, Thrombocytopenic

Purpura, Thrombocytopenic, Idiopathic

Dexamethasone

Prednisone

Study Results

No Results Posted as of Sep 18, 2017