Malignant Tumors of the Digestive SystemPhase 4hetrombopagNCT05575986
Herombopag Olamine in the Treatment of Thrombocytopenia After Chemotherapy
A Phase 4 study testing Hetrombopag Olamine in people with Malignant Tumors of the Digestive System and Trombocitopenia, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
To evaluate the efficacy and safety of hetrombopag in the treatment of thrombocytopenia after chemotherapy in patients with digestive system malignant tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Tumors of the Digestive System, Trombocitopenia
- What is being tested?
- Hetrombopag Olamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Oct 2022to Dec 2023
- Phase
- Phase 4
- 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
- Volunteer to participate in clinical research and sign informed consent;
- Age ≥18 years;
- Digestive system malignancy confirmed by histology or cytology; Having used oxaliplatin combined with fluorouracil for at least one cycle of 21-day chemotherapy regimen (CAPOX or SOX regimen), platelet index after chemotherapy: ≥25×109/L and ≤75×109/L;
- At least 10 days between TPO, IL-11 or platelet transfusion;
- ECOG 0 to 2 points;
- Expected survival time > 3 months;
- Sufficient organ function for subsequent chemotherapy;
- Women of reproductive age must be willing to use adequate contraception during the study of drug treatment.
Who cannot join
- Thrombocytopenia caused by non-tumor chemotherapy drugs occurred within 6 months before screening, including but not limited to EDTA-dependent pseudothrombocytopenia, hypersplenism, infection, and bleeding;
- Have any hematological malignancies, including leukemia, myeloma, bone marrow proliferative diseases, lymphoma or bone marrow proliferative diseases;
- Clinically significant acute or active bleeding within the week prior to screening;
- Subject has medically known hereditary prethrombotic syndrome (e.g., factor V Leiden mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII) deficiency)
- The subject has a history of major cardiovascular disease (e.g., congestive heart failure (New York Heart Association Class 3/ cardiac function), known arrhythmias (e.g., atrial fibrillation) that increase the risk of thromboembolic events, coronary stenting, angioplasty, or coronary artery bypass grafting);
- Subjects had a history of arterial or venous thrombosis within 3 months before screening;
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- Use of a vitamin K antagonist (including low molecular weight heparin, factor Xa inhibitor, or thrombin inhibitor) within 7 days prior to screening;
- The subject has a history of chronic platelet or hemorrhagic disorders, or thrombocytopenia from causes other than CIT (e.g., chronic liver disease or immune thrombocytopenic purpura);
- TPO, IL-11 or platelet infusion were used within 10 days before enrollment;
- Previous use of thrombopoietin receptor agonists (e.g., eltrobopag, romiestine, etc.)
- Those who cannot be treated with oral drugs;
- Allergic to hetrombopag or any excipient;
- Those whose organ function could not tolerate further antitumor therapy as assessed by the investigator; This product is not recommended for use or discontinuation of treatment in patients who meet any of the following criteria for liver function
- ALT and AST > 8 x ULN.
- ALT or AST>5×ULN for 2 weeks;
- ALT or AST>3xULN (total bilirubin >2xULN or INR>1.5);
- ALT or AST>3×ULN with progressive fatigue, nausea, vomiting, right upper abdominal pain or tenderness, fever, rash, and/or eosinophilia (>5%).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
xianglin Yuan
Wuhan, Hubei, 430000
xianglin Yuan, doctor, 13667241722, yuanxianglin@hust.edu.cn
About this study
Official title: An Exploring Single Arm Study on the Efficacy and Safety of Herombopag Olamine in the Treatment of Thrombocytopenia After Chemotherapy in Malignant Tumors of the Digestive System
To evaluate the efficacy and safety of hetrombopag in the treatment of thrombocytopenia after chemotherapy in patients with digestive system malignant tumors
- Being tested
- Hetrombopag Olamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hetrombopag OlamineDrug
Hetrombopag Olamine 7.5mg orally, once a day, for 14 days. This product should be taken on an empty stomach, 2 hours after oral administration before eating, avoid taking it with meals.
| Study group | Role | What they receive |
|---|---|---|
| Observation group | Experimental | Herombopag Olamine Tablets Receives: Drug: Hetrombopag Olamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days required for platelet recovery to ≥75×10^9/ L
Days required for platelet recovery to ≥75×10^9/ L
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (2)
The lowest platelet count
The lowest platelet count
Measured: At the end of Cycle 2 (each cycle is 28 days)
Safety of treatment
Measure of time from study enrollment until progression.
Measured: 2 Cycle (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Tumors of the Digestive SystemStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianglin Yuan, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575986
- Sponsor's protocol ID
- HR-OBU-HuB-CA-II-019
- Acronym
- hetrombopag
- Status last verified
- Oct 2022
- First submitted
- 25 Sep 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- 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 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploring Single Arm Study on the Efficacy and Safety of Herombopag Olamine in the Treatment of Thrombocytopenia After Chemotherapy in Malignant Tumors of the Digestive System
- ClinicalTrials.gov ID
- NCT05575986
- Acronym / sponsor ID
- hetrombopag / HR-OBU-HuB-CA-II-019
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 12 Oct 2022 (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.
To evaluate the efficacy and safety of hetrombopag in the treatment of thrombocytopenia after chemotherapy in patients with digestive system malignant tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation group | Experimental | Drug: Hetrombopag OlamineHerombopag Olamine Tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Volunteer to participate in clinical research and sign informed consent;
- Age ≥18 years;
- Digestive system malignancy confirmed by histology or cytology; Having used oxaliplatin combined with fluorouracil for at least one cycle of 21-day chemotherapy regimen (CAPOX or SOX regimen), platelet index after chemotherapy: ≥25×109/L and ≤75×109/L;
- At least 10 days between TPO, IL-11 or platelet transfusion;
- ECOG 0 to 2 points;
Key exclusion criteria (17 listed)
- Thrombocytopenia caused by non-tumor chemotherapy drugs occurred within 6 months before screening, including but not limited to EDTA-dependent pseudothrombocytopenia, hypersplenism, infection, and bleeding;
- Have any hematological malignancies, including leukemia, myeloma, bone marrow proliferative diseases, lymphoma or bone marrow proliferative diseases;
- Clinically significant acute or active bleeding within the week prior to screening;
- Subject has medically known hereditary prethrombotic syndrome (e.g., factor V Leiden mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII) deficiency)
- The subject has a history of major cardiovascular disease (e.g., congestive heart failure (New York Heart Association Class 3/ cardiac function), known arrhythmias (e.g., atrial fibrillation) that increase the risk of thromboembolic events, coronary stenting, angioplasty, or coronary artery bypass grafting);
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 OlamineHetrombopag Olamine 7.5mg orally, once a day, for 14 days. This product should be taken on an empty stomach, 2 hours after oral administration before eating, avoid taking it with meals. | Drug | Observation group |
Primary outcome
Days required for platelet recovery to ≥75×10^9/ L
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Days required for platelet recovery to ≥75×10^9/ L
2 secondary outcomes
The lowest platelet count
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Safety of treatment
Time frame: 2 Cycle (each cycle is 28 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- 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. 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 4 study testing Hetrombopag Olamine in people with Malignant Tumors of the Digestive System and Trombocitopenia, run by Huazhong University of Science and Technology 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 17 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 12 Oct 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days required for platelet recovery to ≥75×10^9/ L (time frame: At the end of Cycle 1 (each cycle is 28 days)). 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 12 Oct 2022.