Caffeic Acid Tablets as a Second-line Therapy for ITP

NCT02351622 | Completed Phase 3 DMC

• 1 other identifier: ITP-Caffeic acid
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Proposed criteria for assessing response to ITP treatments

  1. Complete response (CR)： A platelet count ≥ 100 \* 10\^9/L measured on two occasions \> 7 days apart and the absence of bleeding. 2. 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. 3. 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. 4. Relapses: platelet count falls below 30×10\^9/L or bleeding accrues after achieving R or CR.

  3 months after treatment started

Study Arms (2)

caffeic acid tablet and dexamethasone

EXPERIMENTAL

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.

Drug: Caffeic acid; Drug: Dexamethasone

Placebo and dexamethasone

ACTIVE COMPARATOR

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.

Drug: Dexamethasone; Drug: Placebo

Interventions

Caffeic acid DRUG

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

Also known as: Caffeic acid tablet

caffeic acid tablet and dexamethasone

Dexamethasone 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; caffeic acid tablet and dexamethasone

Placebo DRUG

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

Also known as: Placebo tablet

Placebo and dexamethasone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead
• Shandong Provincial Hospital: collaborator
• Qianfoshan Hospital: collaborator
• Anhui Medical University: collaborator
• Qingdao University: collaborator

Study Sites (1)

Shandong University Qilu hospital

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

caffeic acid; Dexamethasone

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Ming Hou, MD, PhD

  Shandong University Qilu Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: January 30, 2015
• Study Start: September 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 20, 2016

Record last verified: 2015-03

Locations

CN (1)