Caffeic Acid Combining High-dose Dexamethasone in Management of ITP

Last updated: March 19, 2020
Sponsor: Shandong University
Overall Status: Completed

Phase

4

Condition

Thrombocytopenia And Thrombocytopenia Prevention

Immune (Idiopathic) Thrombocytopenic Purpura (Itp)

White Cell Disorders

Treatment

N/A

Clinical Study ID

NCT02556814
ITP-Caffeic acid + HD-DXM
  • Ages 18-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1.Meet the diagnostic criteria for immune thrombocytopenia; 2.Untreated hospitalizedpatients, may be male or female, between the ages of 18 ~ 80 years; 3.To show aplatelet count <30 * 10^9/L, and with bleeding manifestations; 4.Willing and able tosign written informed consent

Exclusion

Exclusion Criteria:

  • 1.Received chemotherapy or anticoagulants or other drugs affecting the platelet countswithin 3 months before the screening visit 2.Received second-line ITP-specifictreatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc)within 3 months before the screening visit 3.Received high-dose steroids or IVIG inthe 3 weeks prior to the start of the study 4.Current HIV infection or hepatitis Bvirus or hepatitis C virus infections 5.Severe medical condition (lung, hepatic orrenal disorder) other than chronic ITP. Unstable or uncontrolled disease or conditionrelated to or impacting cardiac function (e.g., unstable angina, congestive heartfailure, uncontrolled hypertension or cardiac arrhythmia) 6.Female patients who arenursing or pregnant, who may be pregnant, or who contemplate pregnancy during thestudy period 7.Have a known diagnosis of other autoimmune diseases, established in themedical history and laboratory findings with positive results for the determination ofantinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or directCoombs test 8.Patients who are deemed unsuitable for the study by the investigator

Study Design

Total Participants: 214
Study Start date:
September 01, 2015
Estimated Completion Date:
October 31, 2018

Study 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.

Connect with a study center

  • Qilu Hospital, Shandong University

    Jinan, Shandong
    China

    Site Not Available

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