HerombopagPhase 2NCT06838949
A Clinical Study on the Efficacy and Safety of Herombopag in the Treatment of Senile Primary ITP
A Phase 2 study testing herombopag olamine tablets in people with Herombopag, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
The objective of this study was to evaluate the efficacy and safety of Herombopag in the treatment of elderly patients with ITP. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Herombopag
- What is being tested?
- herombopag olamine tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2025to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily participated in the study and signed informed consent;
- Age ≥60 years old, gender unlimited;
- ECOG PS ≤2;
- Expected survival ≥6 months;
- A definitive diagnosis of ITP, including newly diagnosed, chronic, and persistent ITP;
- PLT < 30×109/L for at least two consecutive times with an interval of at least 1 day before medication
- Patients with laboratory test results meet the following criteria: a. alanine aminotransferase (ALT) 3.0 x or less normal limit (ULN), aspartate aminotransferase (AST) 3.0 x ULN or less; b. Serum total bilirubin ≤1.5×ULN; c. Serum creatinine ≤1.5×ULN;
- The researchers determined that patients could be treated with hexapopal.
Who cannot join
- Patients who did not respond to previous treatment with herombopag;
- A history of allergy to thrombopoietin receptor agonist (TPO-RA) drugs;
- Combined with other important organ dysfunction, such as liver and kidney failure, cardiac insufficiency, etc.
- Secondary thrombocytopenia, such as rheumatic immune disease, chronic liver disease, hyperlienism, malignant hematologic disease, bone marrow hematopoietic exhaustion disease (such as AA, MDS), hereditary thrombocytopenia, CVID, drug-induced thrombocytopenia, etc.;
- Receive TPO-RA medication within 2 weeks prior to treatment;
- Non-steroidal anti-inflammatory drugs (aspirin, salicylate, etc.) and anticoagulants (warfarin, clopidogrel, etc.) should be taken during treatment, which have an impact on platelet function.
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- There are severe active bleeding symptoms, such as gastrointestinal bleeding, intracranial bleeding, etc.
- Severe thrombotic disease, such as transient ischemic attack, myocardial infarction, pulmonary embolism, deep vein thrombosis, and disseminated intravascular coagulation (DIC), occurred within 6 months prior to the screening period;
- Have a New York Heart Society (NYHA) Class 3 or 4 congestive heart failure, or have a history of NYHA Class 3/4 congestive heart failure with a left ejection fraction (LVEF) of < 45% within 4 weeks prior to treatment;
- Positive anti-human immunodeficiency virus antibody or anti-treponema pallidum specific antibody; Hepatitis virus positive, such as HBV, HCV, etc.
- A history of cirrhosis;
- Bone marrow reticulum fiber staining (MF) ≥2 grade;
- Have an active infection that is difficult to control;
- Have a history of or accompanied by malignant tumors;
- Pregnant or lactating women;
- Any other conditions that the investigator determines are not suitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese academy of medical science and blood disease hospital
Tianjin
Yunfei Chen, +8618502220788, chenyunfei@ihcams.ac.cn
About this study
Official title: A Clinical Study on the Efficacy and Safety of Herombopag in the Treatment of Senile Primary Immune Thrombocytopenia
The objective of this study was to evaluate the efficacy and safety of Herombopag in the treatment of elderly patients with ITP.
Read the detailed description
This is a single-arm, prospective clinical study to evaluate the efficacy and safety of herombopag in the treatment of elderly patients with ITP. The study will include 80 patients. Screening of patients will be 2 weeks after the longest period, to enter after the treatment period, accept the herombopag 5 mg, once daily, on an empty stomach, oral medication can be eating only 2 hours, and 24 weeks of treatment, and adjust the dosage according to the platelet count. If patients do not respond to treatment after 8 weeks, it is recommended to withdraw from the study and continue safety visits for 4 weeks. During treatment, the patient continues treatment until the investigator assesses the occurrence of intolerable toxicity, disease progression, withdrawal of informed consent, or other discontinuation criteria specified in the protocol (whichever occurs first). Follow-up treatment for patients who withdraw from treatment due to safety or ineffectiveness is determined by the investigator according to clinical practice. Safety assessment during treatment, including vital signs, physical examination, laboratory examination, etc.; Check your blood routine at least once a week. A 4-week safety visit was performed after the final treatment.
- Conditions
- Herombopag
- Being tested
- herombopag olamine tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
herombopag olamine tabletsDrug
The patient received herombopag 5mg/d at the beginning of the day, was orally taken on an empty stomach in the morning, and could eat 2 hours after taking the drug, once a day for 24 weeks. Investigators will adjust the dosage of herombopag once a week according to the platelet count, with a maximum dosage of 7.5 mg per day. Efficacy and safety were evaluated once a week.
| Study group | Role | What they receive |
|---|---|---|
| Herombopag | Experimental | Herombopag 2.5mg per tablet Receives: Drug: herombopag olamine tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with platelet count ≥30×109/L
Proportion of subjects with a platelet count ≥ 30 × 10^9/L and at least twice the baseline platelet count without bleeding at week 8
Measured: 8 weeks
Secondary outcomes (7)
Proportion of patients with platelet count ≥50×109/L
Proportion of patients with platelet count ≥50×109/L within 8 weeks of treatment
Measured: 8 weeks
Proportion of patients with platelet count ≥100×109/L
Proportion of patients who achieved CR within 8 weeks of treatment
Measured: 8 weeks
Duration from treatment initiation to platelet count ≥30×10^9/L and ≥50×10^9/L
The time of first Platelet≥30×109/L and ≥50×109/L
Measured: 24 weeks
Sustained response at 24 weeks of treatment
Sustained response at 24 weeks of treatment defined as 8 weeks after the last visit, at least 6 visits with platelets ≥30×109/L, greater than 2 times of baseline, and no bleeding
Measured: 24 weeks
The change in bleeding score before treatment and 8 weeks after treatment assessed using the world health organization (WHO) bleeding scale
The change in bleeding score before treatment and 8 weeks after treatment according to the reported World Health Organization's Bleeding Scale. The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss.
Measured: 8 weeks
Emergency treatment
The proportion of subjects who received emergency treatment within 8 weeks and during the entire study period.
Measured: 8 weeks
incidence of treatment-emergent Adverse Events and TRAE
Incidence, severity, and relationship of treatment emergent adverse events after treatment as assessed by CTCAE v5.0
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start3 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerombopagStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yunfei Chen, Principal investigator, Chinese Academy of Medical Science and Blood Disease Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838949
- Sponsor's protocol ID
- IIT2023054
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Efficacy and Safety of Herombopag in the Treatment of Senile Primary Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT06838949
- Acronym / sponsor ID
- IIT2023054
- Conditions
- Herombopag
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Feb 2025 (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 objective of this study was to evaluate the efficacy and safety of Herombopag in the treatment of elderly patients with ITP.
Detailed description
This is a single-arm, prospective clinical study to evaluate the efficacy and safety of herombopag in the treatment of elderly patients with ITP. The study will include 80 patients. Screening of patients will be 2 weeks after the longest period, to enter after the treatment period, accept the herombopag 5 mg, once daily, on an empty stomach, oral medication can be eating only 2 hours, and 24 weeks of treatment, and adjust the dosage according to the platelet count. If patients do not respond to treatment after 8 weeks, it is recommended to withdraw from the study and continue safety visits for 4 weeks. During treatment, the patient continues treatment until the investigator assesses the occurrence of intolerable toxicity, disease progression, withdrawal of informed consent, or other discontinuation criteria specified in the protocol (whichever occurs first). Follow-up treatment for patients who withdraw from treatment due to safety or ineffectiveness is determined by the investigator according to clinical practice. Safety assessment during treatment, including vital signs, physical examination, laboratory examination, etc.; Check your blood routine at least once a week. A 4-week safety visit was performed after the final treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Herombopag | Experimental | Drug: herombopag olamine tabletsHerombopag 2.5mg per tablet |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients voluntarily participated in the study and signed informed consent;
- Age ≥60 years old, gender unlimited;
- ECOG PS ≤2;
- Expected survival ≥6 months;
- A definitive diagnosis of ITP, including newly diagnosed, chronic, and persistent ITP;
Key exclusion criteria (16 listed)
- Patients who did not respond to previous treatment with herombopag;
- A history of allergy to thrombopoietin receptor agonist (TPO-RA) drugs;
- Combined with other important organ dysfunction, such as liver and kidney failure, cardiac insufficiency, etc.
- Secondary thrombocytopenia, such as rheumatic immune disease, chronic liver disease, hyperlienism, malignant hematologic disease, bone marrow hematopoietic exhaustion disease (such as AA, MDS), hereditary thrombocytopenia, CVID, drug-induced thrombocytopenia, etc.;
- Receive TPO-RA medication within 2 weeks prior to treatment;
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 |
|---|---|---|
| herombopag olamine tabletsThe patient received herombopag 5mg/d at the beginning of the day, was orally taken on an empty stomach in the morning, and could eat 2 hours after taking the drug, once a day for 24 weeks. Investigators will adjust the dosage of herombopag once a week according to the platelet count, with a maximum dosage of 7.5 mg per day. Efficacy and safety were evaluated once a week. | Drug | Herombopag |
Primary outcome
Proportion of patients with platelet count ≥30×109/L
Time frame: 8 weeks
Proportion of subjects with a platelet count ≥ 30 × 10^9/L and at least twice the baseline platelet count without bleeding at week 8
7 secondary outcomes
Proportion of patients with platelet count ≥50×109/L
Time frame: 8 weeks
Proportion of patients with platelet count ≥100×109/L
Time frame: 8 weeks
Duration from treatment initiation to platelet count ≥30×10^9/L and ≥50×10^9/L
Time frame: 24 weeks
Sustained response at 24 weeks of treatment
Time frame: 24 weeks
The change in bleeding score before treatment and 8 weeks after treatment assessed using the world health organization (WHO) bleeding scale
Time frame: 8 weeks
Emergency treatment
Time frame: 8 weeks
incidence of treatment-emergent Adverse Events and TRAE
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Yunfei Chen principal investigator
Chinese Academy of Medical Science and Blood Disease Hospital
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 herombopag olamine tablets in people with Herombopag, run by Institute of Hematology & Blood Diseases Hospital, China 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 8 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 13 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunfei Chen (+8618502220788, chenyunfei@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with platelet count ≥30×109/L (time frame: 8 weeks). 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 13 Mar 2025.