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

Information source: Shandong University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Immune Thrombocytopenia

Intervention: Dexamethasone (Drug); Dexamethasone (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Shandong University

Official(s) and/or principal investigator(s):
Ming Hou, DR., Principal Investigator, Affiliation: Shandong University

Overall contact:
Ming Hou, DR., Phone: +86-531-82169114, Ext: 9879, Email: houming@medmail.com.cn

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).

Clinical Details

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

Primary outcome: Proposed criteria for assessing early response to ITP treatments

Secondary outcome: Safety

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).

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Ming Hou, DR., Phone: +86-531-82169114, Ext: 9879, Email: houming@medmail.com.cn

Qilu Hospital, Shandong University, Jinan, Shandong 250012, China; Recruiting
Ming Hou, Dr., Phone: +86-531-82169114, Ext: 9879, Email: houming@medmail.com.cn
Ming Hou, Dr., Principal Investigator
Additional Information

Related publications:

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, K├╝hne 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.

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.

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.

Starting date: May 2014
Last updated: May 30, 2014

Page last updated: August 23, 2015

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