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/AClinical Study ID
NCT02556814
ITP-Caffeic acid + HD-DXM
Ages 18-75 All Genders
Study Summary
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
Connect with a study center
Qilu Hospital, Shandong University
Jinan, Shandong
ChinaSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.