NCT05943691 - 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 | Crick

Overview

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).

The investigators anticipate to undertaking a parallel group, randomised controlled trial of 100 ITP patients. One part of the participants are randomly selected to receive hetrombopag with starting dose 5mg po qd for 8 weeks（increase daily dose to a maximum of 7.5 mg/day if platelet count\<50000 per μL following at least 2 weeks of treatment) combining with dexamethasone (given at a dose of 40 mg qd for 4 consecutive days). The others are selected to receive high-dose of dexamethasone alone. Patients who do not respond to dexamethasone may receive another cycle of high-dose dexamethasone therapy within 2 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. The purpose of this study is to report the efficacy and safety of Hetrombopag combining with high-dose dexamethasone therapy for the treatment of newly diagnosed ITP.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

ITP - Immune Thrombocytopenia

Interventions

hetrombopag 5mg po qdDRUG

hetrombopag 5mg po qd for 8 weeks, combining with dexamethasone 40 mg qd for 4 days

High-dose DexamethasoneDRUG

dexamethasone 40 mg qd for 4 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shengli Oilfield Central Hospital

Dongying, Shandong, China

RECRUITING

Outcomes

Primary Outcomes

26 week sustained overall response to ITP treatments

Complete response was defined as a platelet count of 100 000 per μL or higher and an absence of bleeding. Partial response was defined as a platelet count of 30000 per μL or higher,and at least a doubling of the baseline platelet count and an absence of bleeding. No response was defined as a platelet count of less than 30000 per μL, or less than two-times increase from baseline platelet count, or bleeding.

Time frame: 26-week after treatment started

Secondary Outcomes

28-day initial complete response to ITP treatment

Complete response was defined as a platelet count of 100 000 per μL or higher and an absence of bleeding. Partial response was defined as a platelet count of 30000 per μL or higher,and at least a doubling of the baseline platelet count and an absence of bleeding. No response was defined as a platelet count of less than 30000 per μL, or less than two-times increase from baseline platelet count, or bleeding.

Time frame: 28 days after treatment started]

28-day initial overall response to ITP treatment

Complete response was defined as a platelet count of 100 000 per μL or higher and an absence of bleeding. Partial response was defined as a platelet count of 30000 per μL or higher,and at least a doubling of the baseline platelet count and an absence of bleeding. No response was defined as a platelet count of less than 30000 per μL, or less than two-times increase from baseline platelet count, or bleeding.

Time frame: 28 days after treatment started

8-week complete response to ITP treatment

Complete response was defined as a platelet count of 100 000 per μL or higher and an absence of bleeding. Partial response was defined as a platelet count of 30000 per μL or higher,and at least a doubling of the baseline platelet count and an absence of bleeding. No response was defined as a platelet count of less than 30000 per μL, or less than two-times increase from baseline platelet count, or bleeding.

Central Contacts

Yan Shi

CONTACT

8682169896 shiyansjj@163.com