Caffeic Acid Combining High-dose Dexamethasone in Management of ITP

Shandong University

Status and phase: Completed; Phase 4

Conditions: Immune Thrombocytopenia

Treatments: Drug: placebo; Drug: Caffeic acid tablets; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02556814

ITP-Caffeic acid + HD-DXM

Details and patient eligibility

About

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).

Full 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.

Enrollment: 214 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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214 participants in 2 patient groups

caffeic acid tablet and dexamethasone

Experimental group

Description:

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.

Treatment:

Drug: Caffeic acid tablets

Drug: Dexamethasone

Placebo and dexamethasone

Active Comparator group

Description:

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.

Treatment:

Drug: placebo

Drug: Dexamethasone