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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02556814
Other study ID # ITP-Caffeic acid + HD-DXM
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2015
Est. completion date October 2018

Study information

Verified date October 2018
Source Shandong University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 214
Est. completion date October 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Caffeic acid tablets
Oral administration of caffeic acid tablets 0.3g three times per day for 3 months
Dexamethasone
Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later.
placebo
Oral administration of placebo tablets 0.3g three times per day for 3 months

Locations

Country Name City State
China Qilu Hospital, Shandong University Jinan Shandong

Sponsors (1)

Lead Sponsor Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary sustained response to ITP treatments percentage of patients maintaining PLT count over 30*10^9 without bleeding 6 months after treatment started
Secondary Evaluation of platelet response 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.
3 months after treatment started
See also
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