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Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP)

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ClinicalTrials.gov Identifier: NCT02642380
Recruitment Status : Withdrawn (No eligible patient was enrolled.)
First Posted : December 30, 2015
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Ming Hou, Shandong University

Brief Summary:
The project was organized by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of different cycles of high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: Dexamethasone (4 cycles) Drug: Dexamethasone (1 cycle) Phase 4

Detailed Description:

The investigators are undertaking a multicenter, randomized, controlled trial of 200 primary ITP adult patients from 11 medical centers in China. One part of the participants are randomly selected to receive four cycles of high-dose dexamethasone (given orally at a dose of 40mg per day for 4 consecutive days every 14 days for 4 cycles), comparing the others with one cycle (given orally at a dose of 40 mg per day for 4 consecutive 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 cycles of high-dose dexamethasone therapy for the treatment of adults with ITP.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP): a Prospective, Randomized Controlled Trial
Study Start Date : November 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018


Arm Intervention/treatment
Experimental: 4 cycles
Oral administration of dexamethasone 40 mg for four consecutive days every 14 days for 4 courses
Drug: Dexamethasone (4 cycles)
dexamethasone 40mg daily for 4 consecutive days every 14 days for 4 courses
Other Name: DXM 4

Active Comparator: 1 cycle
Oral administration of dexamethasone 40 mg for four consecutive days
Drug: Dexamethasone (1 cycle)
dexamethasone 40mg daily for 4 consecutive days
Other Name: DXM 1




Primary Outcome Measures :
  1. sustained response to treatment [ Time Frame: 6 months after treatment started ]
    percentage of patients maintaining PLT count over 30*10^9 without bleeding


Secondary Outcome Measures :
  1. Evaluation of early response [ Time Frame: 2 months after treatment started ]

    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.




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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ~ 80 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642380


Locations
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China, Shandong
Qilu Hospital, Shandong University
Jinan, Shandong, China
Sponsors and Collaborators
Shandong University
Investigators
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Principal Investigator: Ming Hou, MD, PhD Shandong University, Qilu Hospital
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Responsible Party: Ming Hou, Principal Investigator, Shandong University
ClinicalTrials.gov Identifier: NCT02642380    
Other Study ID Numbers: High-dose dexamethasone
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: December 2015
Keywords provided by Ming Hou, Shandong University:
ITP
high-dose dexamethasone
Additional relevant MeSH terms:
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Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors