Caffeic Acid Combining High-dose Dexamethasone in Management of ITP
Study Details
Study Description
Brief Summary
The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of caffeic acid tablets combining with high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
The investigators are undertaking a multicenter, randomized, double blinded placebo-controlled trial of 240 primary ITP adult patients from 8 medical centers in China. One part of the participants are randomly selected to receive caffeic acid tablets (given orally at a dose of 900mg per day for 3 consecutive months), combining with dexamethasone (given orally at a dose of 40 mg per day for 4 days, two cycles with an interval of 10 days); the others are selected to receive high-dose of dexamethasone treatment plus placebo.
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 caffeic acid tablets combining with high-dose dexamethasone therapy for the treatment of adults with ITP.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: caffeic acid tablet and dexamethasone Oral administration of caffeic acid tablets 0.3g three times per day for 3 months. Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later. |
Drug: Caffeic acid tablets
Oral administration of caffeic acid tablets 0.3g three times per day for 3 months
Other Names:
Drug: Dexamethasone
Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later.
|
| Active Comparator: Placebo and dexamethasone Oral administration of placebo tablets 0.3g three times per day for 3 months. Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later. |
Drug: Dexamethasone
Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later.
Drug: placebo
Oral administration of placebo tablets 0.3g three times per day for 3 months
|
Outcome Measures
Primary Outcome Measures
- sustained response to ITP treatments [6 months after treatment started]
percentage of patients maintaining PLT count over 30*10^9 without bleeding
Secondary Outcome Measures
- Evaluation of platelet response [3 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Qilu Hospital, Shandong University | Jinan | Shandong | China |
Sponsors and Collaborators
- Shandong University
Investigators
- Principal Investigator: Ming Hou, MD, PhD, Shandong University Qilu Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ITP-Caffeic acid + HD-DXM