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Caffeic Acid Tablets as a Second-line Therapy for ITP

Primary Purpose

Immune Thrombocytopenia

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Caffeic acid
Dexamethasone
Placebo
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shandong University Qilu hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

caffeic acid tablet and dexamethasone

Placebo and dexamethasone

Arm 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.

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.

Outcomes

Primary Outcome Measures

Proposed criteria for assessing response to ITP treatments
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. Relapses: platelet count falls below 30×10^9/L or bleeding accrues after achieving R or CR.

Secondary Outcome Measures

Full Information

First Posted
January 21, 2015
Last Updated
April 18, 2016
Sponsor
Shandong University
Collaborators
Shandong Provincial Hospital, Qianfoshan Hospital, Anhui Medical University, Qingdao University
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1. Study Identification

Unique Protocol Identification Number
NCT02351622
Brief Title
Caffeic Acid Tablets as a Second-line Therapy for ITP
Official Title
A Multicentre Randomized Study of Caffeic Acid Tablets as a Second-line Therapy for the Treatment of Immune Thrombocytopenia (ITP)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
Collaborators
Shandong Provincial Hospital, Qianfoshan Hospital, Anhui Medical University, Qingdao University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
caffeic acid tablet and dexamethasone
Arm Type
Experimental
Arm 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.
Arm Title
Placebo and dexamethasone
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Caffeic acid
Other Intervention Name(s)
Caffeic acid tablet
Intervention Description
Oral administration of caffeic acid tablet 0.3g three times per day for 1 year
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention 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(s)
Placebo
Other Intervention Name(s)
Placebo tablet
Intervention Description
Sugar pills manufactured to mimic caffeic acid tablet. Oral administration of placebo tablet 0.3g three times per day for 1 year.
Primary Outcome Measure Information:
Title
Proposed criteria for assessing response to ITP treatments
Description
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. Relapses: platelet count falls below 30×10^9/L or bleeding accrues after achieving R or CR.
Time Frame
3 months after treatment started

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet the diagnostic criteria for immune thrombocytopenia Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80 years To show a platelet count <30 * 10^9/L, and with bleeding manifestations Willing and able to sign written informed consent Exclusion Criteria: Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study Current HIV infection or hepatitis B virus or hepatitis C virus infections 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) Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period 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 Patients who are deemed unsuitable for the study by the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Hou, MD, PhD
Organizational Affiliation
Shandong University Qilu Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shandong University Qilu hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China

12. IPD Sharing Statement

Learn more about this trial

Caffeic Acid Tablets as a Second-line Therapy for ITP

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