High-dose Dexamethasone Plus Hetrombopag vs High-dose Dexamethasone Alone as Frontline Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Prospective, Multicenter, Randomized Trial

• Status: Recruiting
• Trial end date: 2024-12-10
• 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 Hetrombopag plus high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong University
• Treatments: Dexamethasone

Criteria

Inclusion Criteria:

• Older than 18 years

• Meet the diagnostic criteria for newly diagnosed immune thrombocytopenia (diagnosed within 3 month);

• platelet count <30*10^9/L, or < 50*10^9/L with bleeding manifestations, both;

• Willing and able to sign written informed consent

Exclusion Criteria:

• secondary thrombocytopenia or graded MF≥2 myelofbrosis based on the European Consensus Scale

• Previous history of treatment for ITP, except Platelet transfusion, ITP-directed Prednisone therapy no more than 2 weeks or TPO therapy no more than 1 week and stopped ≥1 week before randomization

• No response to TPO-RA or rhTPO

• HIV, hepatitis C or B virus infection

• pregnancy or lactation;

• arterial or venous thromboembolism within the 6 months before screening

• total bilirubinalanine, aminotransferase or aspartate transaminase>3×upper limit of normal (ULN), serum creatinine>1.5×ULN

• congestive heart failure (New York Heart Association [NYHA] class III/IV);

• neoplastic disease within the past 5 years;

• liver cirrhosis

• people who could not adhere to the protocol or were planning to have a surgical procedure in 6 months.