Caffeic Acid Combining High-dose Dexamethasone in Management of ITP

NCT ID: NCT02556814

Last Updated: 2020-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-10-31

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.

Conditions

Immune Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

caffeic acid tablet and dexamethasone

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.

Group Type: EXPERIMENTAL

Caffeic acid tablets

Intervention Type: DRUG

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

Dexamethasone

Intervention Type: DRUG

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

Placebo and dexamethasone

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.

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.

placebo

Intervention Type: DRUG

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

Interventions

Caffeic acid tablets

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

Intervention Type: DRUG

Dexamethasone

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

Intervention Type: DRUG

placebo

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

Intervention Type: DRUG

Other Intervention Names

Caffeic acid 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: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

Qilu Hospital, Shandong University

Jinan, Shandong, China

Countries

China

References

Wang R, Liu Y, Wang R, Cao J, Hao Y, Xiao T, Yu Z, Yu W, Chu X, Ran X, Zhu C, Xu R, Xiao J, Deng X, Zhang H, Wang Z, Liu G, Hou M, Hou Y. Caffeic acid tablets plus high-dose dexamethasone versus placebo plus high-dose dexamethasone in patients with newly diagnosed immune thrombocytopenia: A multicenter, double-blind, randomized, controlled, phase 2 trial. Chin Med J (Engl). 2025 Aug 22. doi: 10.1097/CM9.0000000000003783. Online ahead of print.

Reference Type: DERIVED

PMID: 40846660 (View on PubMed)

Other Identifiers

ITP-Caffeic acid + HD-DXM

Identifier Type: -

Identifier Source: org_study_id