Clinical trial 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
Official title: High-dose Dexamethasone Plus Hetrombopag Versus High-dose Dexamethasone Alone as Frontline Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia (ITP):A Prospective Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: ITP - Immune Thrombocytopenia
Keywords: Hetrombopag, Dexamethasone
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: 26 week sustained overall response to ITP treatments
timeFrame: 26-week after treatment started
Secondary outcomes:
measure: 28-day initial complete response to ITP treatment
timeFrame: 28 days after treatment started]
measure: 28-day initial overall response to ITP treatment
timeFrame: 28 days after treatment started
measure: 8-week complete response to ITP treatment
timeFrame: 8 weeks after treatment started
measure: 8-week overall response to ITP treatment
timeFrame: 8 weeks after treatment started
measure: time to response
timeFrame: an average of 6 months
measure: duration of response
timeFrame: through study completion, an average of one year
measure: therapy associated adverse events
timeFrame: through study completion, an average of one year
Other outcomes:
Locations:
city: Dongying
country: China
facility: Shengli Oilfield Central Hospital
state: Shandong
Study officials:
References: