ITP - Immune ThrombocytopeniaPhase 2NCT05943691
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
A Phase 2 study testing hetrombopag 5mg po qd and High-dose Dexamethasone in people with ITP - Immune Thrombocytopenia, run by Shandong University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ITP - Immune Thrombocytopenia
- What is being tested?
- hetrombopag 5mg po qd and High-dose Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2023to 10 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shengli Oilfield Central Hospital
Dongying, Shandong
Liang Wang, MD, 18654620224
About this study
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
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).
Read the 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.
- Conditions
- ITP - Immune Thrombocytopenia
- Being tested
- hetrombopag 5mg po qd, High-dose Dexamethasone
- Keywords
- Hetrombopag, Dexamethasone
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Hetrombopag plus High-dose Dexamethasone | Experimental | Hetrombopag 5mg po qd; HD-DEX 40mg qd for 4 days Receives: Drug: hetrombopag 5mg po qd; Drug: High-dose Dexamethasone |
| High-dose Dexamethasone | Active comparator | HD-DEX 40mg qd for 4 days Receives: Drug: High-dose Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 26-week after treatment started
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 8 weeks after treatment started
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.
Measured: 8 weeks after treatment started
time to response
the time from treatment initiation to achieve a complete response or a partial response
Measured: an average of 6 months
duration of response
the time from achievement of a complete response or a partial response to the loss of response
Measured: through study completion, an average of one year
therapy associated adverse events
Measured: through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start15 Sep 2023 (estimated)
- Primary completion10 Jul 2024 (estimated)
- Study completion10 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ITP - Immune ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Hou, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943691
- Sponsor's protocol ID
- ITP-Hetrombopag plus HD-DEX
- Status last verified
- Sep 2023
- First submitted
- 5 Jul 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05943691
- Acronym / sponsor ID
- ITP-Hetrombopag plus HD-DEX
- Conditions
- ITP - Immune Thrombocytopenia
- Keywords
- Hetrombopag, Dexamethasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (estimated)
- Primary completion
- 10 Jul 2024 (estimated)
- Study completion
- 10 Dec 2024 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hetrombopag plus High-dose Dexamethasone | Experimental | Drug: hetrombopag 5mg po qd, Drug: High-dose DexamethasoneHetrombopag 5mg po qd; HD-DEX 40mg qd for 4 days |
| High-dose Dexamethasone | Active comparator | Drug: High-dose DexamethasoneHD-DEX 40mg qd for 4 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hetrombopag 5mg po qdhetrombopag 5mg po qd for 8 weeks, combining with dexamethasone 40 mg qd for 4 days | Drug | Hetrombopag plus High-dose Dexamethasone |
| High-dose Dexamethasonedexamethasone 40 mg qd for 4 days | Drug | Hetrombopag plus High-dose Dexamethasone, High-dose Dexamethasone |
Primary outcome
26 week sustained overall response to ITP treatments
Time frame: 26-week after treatment started
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.
7 secondary outcomes
28-day initial complete response to ITP treatment
Time frame: 28 days after treatment started]
28-day initial overall response to ITP treatment
Time frame: 28 days after treatment started
8-week complete response to ITP treatment
Time frame: 8 weeks after treatment started
8-week overall response to ITP treatment
Time frame: 8 weeks after treatment started
time to response
Time frame: an average of 6 months
duration of response
Time frame: through study completion, an average of one year
therapy associated adverse events
Time frame: through study completion, an average of one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hetrombopag 5mg po qd and High-dose Dexamethasone in people with ITP - Immune Thrombocytopenia, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Shi (8682169896, shiyansjj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
26 week sustained overall response to ITP treatments (time frame: 26-week after treatment started). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.