Caffeic Acid Tablets as a Second-line Therapy for ITP

A Multicentre Randomized Study of Caffeic Acid Tablets as a Second-line Therapy for the Treatment of Immune Thrombocytopenia (ITP)

Sponsors

Lead Sponsor: Shandong University

Collaborator: Shandong Provincial Hospital
Qianfoshan Hospital
Anhui Medical University
Qingdao University

Source Shandong University
Brief 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.

Detailed 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.

Overall Status Completed
Start Date September 2012
Completion Date December 2013
Primary Completion Date December 2013
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Proposed criteria for assessing response to ITP treatments 3 months after treatment started
Enrollment 103
Condition
Intervention

Intervention Type: Drug

Intervention Name: Caffeic acid

Description: Oral administration of caffeic acid tablet 0.3g three times per day for 1 year

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, 3 cycles in total.

Intervention Type: Drug

Intervention Name: Placebo

Description: Sugar pills manufactured to mimic caffeic acid tablet. Oral administration of placebo tablet 0.3g three times per day for 1 year.

Arm Group Label: Placebo and dexamethasone

Other Name: Placebo tablet

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: 80 Years

Healthy Volunteers: No

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

China

Verification Date

March 2015

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Shandong University

Investigator Full Name: Ming Hou

Investigator Title: Professor and Director

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 tablet 0.3g three times per day for 1 year. Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later, 3 cycles in total.

Label: Placebo and dexamethasone

Type: Active Comparator

Description: Oral administration of placebo tablet 0.3g three times per day for 1 year. Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later, 3 cycles in total.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov