Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP
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ClinicalTrials.gov Identifier: NCT03252457 |
Recruitment Status : Unknown
Verified August 2018 by Ming Hou, Shandong University.
Recruitment status was: Not yet recruiting
First Posted : August 17, 2017
Last Update Posted : August 15, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Purpura, Thrombocytopenic, Idiopathic Immune Thrombocytopenia | Drug: Decitabine Drug: Dexamethasone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter Prospective Randomized Study of Dexamethasone Combined With Decitabine Versus Dexamethasone in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP) |
Estimated Study Start Date : | September 1, 2018 |
Estimated Primary Completion Date : | December 1, 2020 |
Estimated Study Completion Date : | December 1, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: combination treatment group
100 enrolled patients are randomly picked up to take decitabine in combination with dexamethasone at the indicated dose
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Drug: Decitabine
given intravenously at a dose of 3.5mg/m2/d for 4 consecutive days as a cycle and repeated every 2 weeks for 3cycles
Other Name: pharmachemie Drug: Dexamethasone given 40mg/d for 4 consecutive days as a cycle , If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 10, an additional cycle of dexamethasone was given.
Other Name: Hydrocortisone |
Active Comparator: single treatment group
100 enrolled patients are randomly picked up to take dexamethasone at the indicated dose
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Drug: Dexamethasone
given 40mg/d for 4 consecutive days as a cycle , If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 10, an additional cycle of dexamethasone was given.
Other Name: Hydrocortisone |
- Evaluation of platelet response(continuous response rate) [ Time Frame: up to 1 year per subject ]Complete Response:a sustained (≥ 3 months) platelet count ≥100×10^9/L;response: a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia;No response (NR): 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.
- therapy associated adverse events [ Time Frame: up to 1 year per subject ]The number and frequency of therapy associated adverse events

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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 |
Inclusion Criteria:
- Meet the diagnostic criteria for immune thrombocytopenia.
- within 3 months fromdiagnosis,untreated 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.
- Eastern Cooperative Oncology Group(ECOG)performance status ≤ 2.
Exclusion Criteria:
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
- Received high-dose steroids or intravenous immunoglobulin transfusion(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 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.

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): NCT03252457
Contact: Ming Hou, Dr | +86-531-82169114 ext 9879 | houming@medmail.com.cn |
China, Shandong | |
Qilu hospital, Shandong University | |
Jinan, Shandong, China, 250012 |
Principal Investigator: | Ming Hou, Dr | Shandong University |
Responsible Party: | Ming Hou, Professor and Director, Shandong University |
ClinicalTrials.gov Identifier: | NCT03252457 |
Other Study ID Numbers: |
DAC in ITP |
First Posted: | August 17, 2017 Key Record Dates |
Last Update Posted: | August 15, 2018 |
Last Verified: | August 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Purpura Thrombocytopenia immune throbocytopenia |
Thrombocytopenia Purpura Purpura, Thrombocytopenic, Idiopathic Purpura, Thrombocytopenic Blood Platelet Disorders Hematologic Diseases Blood Coagulation Disorders Hemorrhage Pathologic Processes Skin Manifestations Thrombotic Microangiopathies Hemorrhagic Disorders Autoimmune Diseases Immune System Diseases Dexamethasone |
Hydrocortisone Decitabine 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 Antimetabolites, Antineoplastic Antimetabolites |