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

NCT02642380 | Withdrawn Phase 4 DMC

• 1 other identifier: High-dose dexamethasone
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Immune Thrombocytopenia

Keywords

ITP; high-dose dexamethasone

Outcome Measures

Primary Outcomes (1)

• sustained response to treatment

  percentage of patients maintaining PLT count over 30\*10\^9 without bleeding

  6 months after treatment started

Secondary Outcomes (1)

• Evaluation of early response

  2 months after treatment started

Study Arms (2)

4 cycles

EXPERIMENTAL

Oral administration of dexamethasone 40 mg for four consecutive days every 14 days for 4 courses

Drug: Dexamethasone (4 cycles)

1 cycle

ACTIVE COMPARATOR

Oral administration of dexamethasone 40 mg for four consecutive days

Drug: Dexamethasone (1 cycle)

Interventions

Dexamethasone (4 cycles) DRUG

dexamethasone 40mg daily for 4 consecutive days every 14 days for 4 courses

Also known as: DXM 4

4 cycles

Dexamethasone (1 cycle) DRUG

dexamethasone 40mg daily for 4 consecutive days

Also known as: DXM 1

1 cycle

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 \~ 80 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

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, China

Location

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, MD, PhD

  Shandong University Qilu Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 24, 2015
• First Posted: December 30, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: April 20, 2016

Record last verified: 2015-12

Locations

CN (1)