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

Immune Thrombocytopenia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02153060
• Other study ID #: ITP-Dexamethasone
• Status: Completed
• Phase: Phase 2
• First received: May 29, 2014
• Last updated: April 18, 2016
• Start date: May 2014
• Est. completion date: August 2015

Study information

• Verified date: May 2014
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia

2. Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 75 years

3. To show a platelet count <30 * 10^9/L, and with bleeding manifestations

4. Willing and able to sign written informed consent

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit

2. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit

3. Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study

4. Current HIV infection or hepatitis B virus or hepatitis C virus infections

5. 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)

6. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period

7. 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

8. Patients who are deemed unsuitable for the study by the investigator

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia
• Thrombocytosis

Intervention

Drug:
• Dexamethasone
Dexamethasone was given at a dose of 40 mg,daily for 4 consecutive days
• Dexamethasone
Dexamethasone was given at a dose of 20 mg,daily for 4 consecutive days

Locations

Country	Name	City	State
China	Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (8)

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

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. Review. — View 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, Kühne 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months	No
Secondary	Safety	The type and frequency of therapy associated adverse events	1 years	Yes