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An Investigation of Dexamethasone With Different Doses in the Management of Immune Thrombocytopenia (ITP)

Primary Purpose

Immune Thrombocytopenia

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Dexamethasone

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring immune thrombocytopenia, dexamethasone, efficacy, safety

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Meet the diagnostic criteria for immune thrombocytopenia
Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 75 years
To show a platelet count <30 * 10^9/L, and with bleeding manifestations
Willing and able to sign written informed consent

Exclusion Criteria:

Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit
Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit
Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study
Current HIV infection or hepatitis B virus or hepatitis C virus infections
Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period
Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test
Patients who are deemed unsuitable for the study by the investigator

Sites / Locations

Qilu Hospital, Shandong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

20mg dexamethasone group

40mg dexamethasone group

Arm Description

Dexamethasone 20 mg per day, 4 consecutive days

Dexamethasone 40 mg per day, 4 consecutive days

Outcomes

Primary Outcome Measures

Proposed criteria for assessing early response to ITP treatments

Complete response (CR)： A platelet count ≥ 100 * 10^9/L measured on two occasions > 7 days apart and the absence of bleeding. Response (R)： A platelet count ≥ 30 * 10^9/L and a greater than two fold increase in platelet count from baseline measured on two occasions > 7 days apart and the absence of bleeding. No response (NR)： A platelet count < 30 * 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.

Secondary Outcome Measures

Safety

The type and frequency of therapy associated adverse events

Full Information

NCT ID

NCT02153060

First Posted

May 29, 2014

Last Updated

April 18, 2016

Sponsor

Shandong University

Collaborators

Chinese Academy of Medical Sciences, Shandong Provincial Hospital, The First Affiliated Hospital of Dalian Medical University, Peking Union Medical College Hospital, Shandong University of Traditional Chinese Medicine, Anhui Provincial Hospital, Second Hospital of Shanxi Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02153060

Brief Title

An Investigation of Dexamethasone With Different Doses in the Management of Immune Thrombocytopenia (ITP)

Official Title

A Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Different Doses of Dexamethasone for Management of Immune Thrombocytopenia (ITP)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong University

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The project was undertaking by Qilu Hospital of Shandong University and other 7 well-known hospitals in China. In order to report the efficacy and safety of different dose dexamethasone in treating the immune thrombocytopenia (ITP).

Detailed Description

The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 60 adults with ITP from 7 medical centers in China. Part of the participants are randomly selected to receive dexamethasone (given at a dose of 40mg per day for 4 consecutive days) ,the others are selected to receive dexamethasone(given at a dose of 20 mg daily for 4 days). Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of different dose dexamethasone for the treatment of adults with immune thrombocytopenia (ITP).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immune Thrombocytopenia

Keywords

immune thrombocytopenia, dexamethasone, efficacy, safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

20mg dexamethasone group

Arm Type

Experimental

Arm Description

Dexamethasone 20 mg per day, 4 consecutive days

Arm Title

40mg dexamethasone group

Arm Type

Experimental

Arm Description

Dexamethasone 40 mg per day, 4 consecutive days

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Dexamethasone was given at a dose of 40 mg,daily for 4 consecutive days

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Dexamethasone was given at a dose of 20 mg,daily for 4 consecutive days

Primary Outcome Measure Information:

Title

Proposed criteria for assessing early response to ITP treatments

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Safety

Description

The type and frequency of therapy associated adverse events

Time Frame

1 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Meet the diagnostic criteria for immune thrombocytopenia Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 75 years To show a platelet count <30 * 10^9/L, and with bleeding manifestations Willing and able to sign written informed consent Exclusion Criteria: Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study Current HIV infection or hepatitis B virus or hepatitis C virus infections Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test Patients who are deemed unsuitable for the study by the investigator

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Hou, DR.

Organizational Affiliation

Shandong University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Qilu Hospital, Shandong University

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250012

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

19005182

Citation

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.

Results Reference

background

PubMed Identifier

19846889

Citation

Provan D, Stasi R, Newland AC, Blanchette VS, Bolton-Maggs P, Bussel JB, Chong BH, Cines DB, Gernsheimer TB, Godeau B, Grainger J, Greer I, Hunt BJ, Imbach PA, Lyons G, McMillan R, Rodeghiero F, Sanz MA, Tarantino M, Watson S, Young J, Kuter DJ. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010 Jan 14;115(2):168-86. doi: 10.1182/blood-2009-06-225565. Epub 2009 Oct 21.

Results Reference

background

PubMed Identifier

12944568

Citation

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.

Results Reference

background

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An Investigation of Dexamethasone With Different Doses in the Management of Immune Thrombocytopenia (ITP)

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