Caffeic Acid Tablets as a Second-line Therapy for ITP

Last updated: April 18, 2016
Sponsor: Shandong University
Overall Status: Completed

Phase

3

Condition

White Cell Disorders

Thrombocytopenia And Thrombocytopenia Prevention

Dysfunctional Uterine Bleeding

Treatment

N/A

Clinical Study ID

NCT02351622
ITP-Caffeic acid
  • Ages 18-80
  • All Genders

Study Summary

The investigators are undertaking a multicentre, randomised controlled trial of 120 adults with newly diagnosed ITP from 5 medical centers in China. Part of the participants are randomly selected to receive caffeic acid tablets combining dexamethasone and the other part are selected to receive high-dose dexamethasone treatment. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Meet the diagnostic criteria for immune thrombocytopenia

  2. Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80years

  3. To show a platelet count <30 * 10^9/L, and with bleeding manifestations

  4. Willing and able to sign 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-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 cardiacarrhythmia)

  6. Female patients who are nursing or pregnant, who may be pregnant, or who contemplatepregnancy during the study period

  7. Have a known diagnosis of other autoimmune diseases, established in the medicalhistory 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: 103
Study Start date:
September 01, 2012
Estimated Completion Date:
December 31, 2013

Study Description

All participants' platelet count will be monitored weekly. Response will be evaluated after 3, 6 and 12 months after treatment. If the participant did not get complete response or response after 3 months, he would quit the trail.

Connect with a study center

  • Shandong University Qilu hospital

    Jinan, Shandong 250012
    China

    Site Not Available

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