Caffeic Acid Combining High-dose Dexamethasone in Management of ITP

NCT02556814 | Completed Phase 4 DMC

• 1 other identifier: ITP-Caffeic acid + HD-DXM
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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).

Conditions

Immune Thrombocytopenia

Keywords

ITP; Caffeic Acid; dexamethasone

Outcome Measures

Primary Outcomes (1)

• sustained response to ITP treatments

  percentage of patients maintaining PLT count over 30\*10\^9 without bleeding

  6 months after treatment started

Secondary Outcomes (1)

• Evaluation of platelet response

  3 months after treatment started

Study Arms (2)

caffeic acid tablet and dexamethasone

EXPERIMENTAL

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.

Drug: Caffeic acid tablets; Drug: Dexamethasone

Placebo and dexamethasone

ACTIVE COMPARATOR

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.

Drug: Dexamethasone; Drug: placebo

Interventions

Caffeic acid tablets DRUG

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

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.

Placebo and dexamethasone; caffeic acid tablet and dexamethasone

placebo DRUG

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

Placebo and dexamethasone

Eligibility Criteria

• Age: 18 Years - 75 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; 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, China

Location

Related Publications (1)

• 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.

  PMID: 40846660 DERIVED

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 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: September 22, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 20, 2020

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)