Caffeic Acid Combining High-dose Dexamethasone in Management of ITP

A Prospective, Multicenter, Placebo Controlled Study on Caffeic Acid Tablet Combining High-dose Dexamethasone in Management of Adult Primary Immune Thrombocytopenia (ITP)

Sponsors

Lead Sponsor: Shandong University

Source Shandong University
Brief 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).

Detailed 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.

Overall Status Completed
Start Date September 2015
Completion Date October 2018
Primary Completion Date March 2018
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
sustained response to ITP treatments 6 months after treatment started
Secondary Outcome
Measure Time Frame
Evaluation of platelet response 3 months after treatment started
Enrollment 214
Condition
Intervention

Intervention Type: Drug

Intervention Name: Caffeic acid tablets

Description: Oral administration of caffeic acid tablets 0.3g three times per day for 3 months

Arm Group Label: caffeic acid tablet and dexamethasone

Other Name: Caffeic acid tablet

Intervention Type: Drug

Intervention Name: Dexamethasone

Description: Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later.

Intervention Type: Drug

Intervention Name: placebo

Description: Oral administration of placebo tablets 0.3g three times per day for 3 months

Arm Group Label: Placebo and dexamethasone

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Ming Hou, MD, PhD Principal Investigator Shandong University, Qilu Hospital
Location
Facility: Qilu Hospital, Shandong University
Location Countries

China

Verification Date

October 2018

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Shandong University

Investigator Full Name: Ming Hou

Investigator Title: Professor and Director

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: caffeic acid tablet and dexamethasone

Type: Experimental

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.

Label: Placebo and dexamethasone

Type: Active Comparator

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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov