Glycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITP

• Status: Recruiting
• Trial end date: 2021-06-10
• Target enrollment: 0
• Participant gender: All

Summary

The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of glycyrrhetinic acid combining with high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong University
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Glycyrrhetinic Acid

Criteria

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;

• Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac

• 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.