Caffeic Acid Tablets as a Second-line Therapy for ITP

NCT ID: NCT02351622

Last Updated: 2016-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-12-31

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.

Conditions

Immune Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

caffeic acid tablet and dexamethasone

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.

Group Type: EXPERIMENTAL

Caffeic acid

Intervention Type: DRUG

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

Dexamethasone

Intervention Type: DRUG

Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later, 3 cycles in total.

Placebo and dexamethasone

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.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later, 3 cycles in total.

Placebo

Intervention Type: DRUG

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

Interventions

Caffeic acid

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

Intervention Type: DRUG

Dexamethasone

Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later, 3 cycles in total.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Caffeic acid tablet; 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

Qianfoshan Hospital

OTHER

Sponsor Role: collaborator

Anhui Medical University

OTHER

Sponsor Role: collaborator

Qingdao University

OTHER

Sponsor Role: collaborator

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Ming Hou

Professor and Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Hou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shandong University Qilu Hospital

Locations

Shandong University Qilu hospital

Jinan, Shandong, China

Countries

China

Other Identifiers

ITP-Caffeic acid

Identifier Type: -

Identifier Source: org_study_id