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

NCT02153060 | Completed Phase 2 DMC

• 1 other identifier: ITP-Dexamethasone
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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).

Conditions

Immune Thrombocytopenia

Keywords

immune thrombocytopenia; dexamethasone; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• Proposed criteria for assessing early response to ITP treatments

  1. Complete response (CR)： A platelet count ≥ 100 \* 10\^9/L measured on two occasions \> 7 days apart and the absence of bleeding. 2. 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. 3. 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

Secondary Outcomes (1)

• Safety

  1 years

Study Arms (2)

20mg dexamethasone group

EXPERIMENTAL

Dexamethasone 20 mg per day, 4 consecutive days

Drug: Dexamethasone

40mg dexamethasone group

EXPERIMENTAL

Dexamethasone 40 mg per day, 4 consecutive days

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

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

40mg dexamethasone group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (3)

• 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

• 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.

  PMID: 19846889 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

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Ming Hou, DR.

  Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 2, 2014
• Study Start: May 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 20, 2016

Record last verified: 2014-05

Locations

CN (1)