Skip to main content
OpenTrials
Completed

NCT Number: NCT02351622

Caffeic Acid Tablets as a Second-line Therapy for ITP

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shandong University Qilu hospital

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caffeic acid

Drug

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

Other names: Caffeic acid tablet

Dexamethasone

Drug

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

Placebo

Drug

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

Other names: Placebo tablet

Primary outcomes

  1. Proposed criteria for assessing response to ITP treatments

    Time frame: 3 months after treatment started

    • 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.

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Collaborators

  • Anhui Medical University
  • Qianfoshan Hospital
  • Qingdao University
  • Shandong Provincial Hospital

Registry information

Official study title

A Multicentre Randomized Study of Caffeic Acid Tablets as a Second-line Therapy for the Treatment of Immune Thrombocytopenia (ITP)

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 30, 2015
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.