Back to resultsHigh-dose Dexamethasone Plus Hetrombopag vs High-dose Dexamethasone Alone as Frontline Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Prospective, Multicenter, Randomized Trial
Primary Purpose
ITP - Immune Thrombocytopenia
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
hetrombopag 5mg po qd
High-dose Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for ITP - Immune Thrombocytopenia focused on measuring Hetrombopag, Dexamethasone
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.
Sites / Locations
- Shengli Oilfield Central HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hetrombopag plus High-dose Dexamethasone
High-dose Dexamethasone
Arm Description
Hetrombopag 5mg po qd; HD-DEX 40mg qd for 4 days
HD-DEX 40mg qd for 4 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
8-week overall response to ITP treatment
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 to response
the time from treatment initiation to achieve a complete response or a partial response
duration of response
the time from achievement of a complete response or a partial response to the loss of response
therapy associated adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05943691
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
July 10, 2024 (Anticipated)
Study Completion Date
December 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ITP - Immune Thrombocytopenia
Keywords
Hetrombopag, Dexamethasone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hetrombopag plus High-dose Dexamethasone
Arm Type
Experimental
Arm Description
Hetrombopag 5mg po qd; HD-DEX 40mg qd for 4 days
Arm Title
High-dose Dexamethasone
Arm Type
Active Comparator
Arm Description
HD-DEX 40mg qd for 4 days
Intervention Type
Drug
Intervention Name(s)
hetrombopag 5mg po qd
Intervention Description
hetrombopag 5mg po qd for 8 weeks, combining with dexamethasone 40 mg qd for 4 days
Intervention Type
Drug
Intervention Name(s)
High-dose Dexamethasone
Intervention Description
dexamethasone 40 mg qd for 4 days
Primary Outcome Measure Information:
Title
26 week sustained overall response to ITP treatments
Description
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 Outcome Measure Information:
Title
28-day initial complete response to ITP treatment
Description
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]
Title
28-day initial overall response to ITP treatment
Description
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
Title
8-week complete response to ITP treatment
Description
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
8 weeks after treatment started
Title
8-week overall response to ITP treatment
Description
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
8 weeks after treatment started
Title
time to response
Description
the time from treatment initiation to achieve a complete response or a partial response
Time Frame
an average of 6 months
Title
duration of response
Description
the time from achievement of a complete response or a partial response to the loss of response
Time Frame
through study completion, an average of one year
Title
therapy associated adverse events
Time Frame
through study completion, an average of one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Shi
Phone
8682169896
Email
shiyansjj@163.com
Facility Information:
Facility Name
Shengli Oilfield Central Hospital
City
Dongying
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Wang, MD
Phone
18654620224
12. IPD Sharing Statement
Learn more about this trial
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
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