Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03252457
• Date of registration: 14/08/2017
• Prospective Registration: Yes
• Primary sponsor: Shandong University
• Public title: Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP
• Scientific title: A Multicenter Prospective Randomized Study of Dexamethasone Combined With Decitabine Versus Dexamethasone in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)
• Date of first enrolment: September 1, 2018
• Target sample size: 200
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT03252457
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

China

Contacts

• Name: Ming Hou, Dr

• Name: Ming Hou, Dr
• Affiliation: Shandong University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia.

2. within 3 months fromdiagnosis,untreated 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. Eastern Cooperative Oncology Group(ECOG)performance status = 2.

Exclusion Criteria:

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

2. Received high-dose steroids or intravenous immunoglobulin transfusion(IVIG) in the 3
weeks prior to the start of the study.

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

4. Severe medical condition (lung, hepatic or renal disorder) other than 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)

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

6. 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.

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Purpura, Thrombocytopenic, Idiopathic

Immune Thrombocytopenia

Intervention(s)

Drug: Dexamethasone

Drug: Decitabine

Primary Outcome(s)

Evaluation of platelet response(continuous response rate) [Time Frame: up to 1 year per subject]

Secondary Outcome(s)

therapy associated adverse events [Time Frame: up to 1 year per subject]

Secondary ID(s)

DAC in ITP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Second Affiliated Hospital of Medical College Shandong University

Chinese Academy of Medical Sciences

Qingdao Central Hospital

Shandong Provincial Hospital