Chemotherapy-Induced ThrombocytopeniaPhase 3NCT05261646
A Clinical Study of Hetrombopag Olamine Tablets in Adults Receiving 21-day Cycles of Chemotherapy for Solid Tumours, Who Are Delayed for at Least 1 Week From Their Scheduled Cycle Because of Chemotherapy-induced Thrombocytopenia
A Phase 3 study testing Hetrombopag in people with Chemotherapy-Induced Thrombocytopenia, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
The study is aimed to evaluate the efficacy of different doses of hetrombopag compared to placebo, measured by the proportion of subjects that can complete two planned consecutive chemotherapy cycles with no modification of chemotherapy regimen (i.e., delayed start, dose reduction, omission, or discontinuation)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-Induced Thrombocytopenia
- What is being tested?
- Hetrombopag
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2022to 15 Dec 2025
- Phase
- Phase 3
- 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
- Male or female gender, age ≥18 years.
- Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma [NSCLC], breast, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer).
- Receiving a chemotherapy cycle of 21 days with one or more of the following chemotherapeutic drugs:
- Antimetabolites, including gemcitabine, etc.
- Platinum-based agents, including carboplatin, nedaplatin, cisplatin, and lobaplatin, etc.
- Anthracyclines, including doxorubicin, daunorubicin, epirubicin, etc.
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- Alkylating agents, including cyclophosphamide, ifosfamide, etc.
- Delay for at least 1 week from the scheduled chemotherapy cycle because of thrombocytopenia (PC <75×109/L for 4 weeks after the start of the previous chemotherapy cycle.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Expected survival ≥ 6 months at screening.
- At least 2 remaining chemotherapy cycles with current chemotherapy regimen.
- Agreement for subjects of childbearing potential to take effective contraceptive measures throughout the study (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive diaphragm, contraceptive cream, contraceptive suppository, abstinence, and inserted intrauterine devices, etc.); except female subjects who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation or have been in menopause for more than 1 year, and male subjects who have undergone bilateral vasectomy or ligation.
- Signed ICF for voluntary participation in the study and good compliance.
Who cannot join
- PC <25×109/L or ≥75 x 109/L at screening or enrollment.
- Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
- Hematologic malignancies.
- Thrombocytopenia caused by reasons other than chemotherapy, including but not limited to chronic liver disease, hypersplenism, infection, and hemorrhage, within 6 months before screening.
- Intracranial metastases or disease.
- Bone marrow involvement or bone marrow metastasis on routine imaging.
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- Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
- Pelvic, spinal radiotherapy, or large-field bone radiation received within 3 months prior to screening.
- Severe cardiovascular disorders or interventions within 6 months before screening: New York Heart Association (NYHA) Class III-IV; arrhythmias known to increase the risk of thromboembolism (e.g., atrial fibrillation); prolonged QTc (>450 msec for males and >460 msec for females); coronary artery angioplasty, stenting, or bypass grafting.
- Any arterial or venous thrombosis (e.g., deep vein thrombosis, pulmonary embolism, transient ischemic attack/stroke, or myocardial infarction) within 6 months prior to screening.
- Known bleeding disorders, platelet dysfunction.
- Use of anticoagulants or non-steroidal anti-inflammatory drugs (NSAIDs) within 7 days of screening. The use of low dose aspirin (81 mg) is allowed.
- Severe hemorrhage (e.g., gastrointestinal, or intracranial hemorrhage) within 2 weeks before screening.
- Absolute neutrophil count (ANC) <1.5× 109/L, or Hb <80 g/L. Use of granulocyte colony stimulating factor, red blood cell, or erythropoietin infusion therapy that meets routine clinical practice is allowed.
- Significantly abnormal liver function:
- For subjects without liver metastasis: alanine aminotransferase/aspartate aminotransferase (ALT/AST) > 3 × ULN (upper limit of normal), TBL > 3 × ULN.
- For subjects with liver metastases: ALT/AST ≥ 5 × ULN, TBL > 3 × ULN.
- Abnormal renal function: estimated glomerular filtration rate (eGFR) ≤ 60 mL/min (Cockcroft-Gault estimated creatinine clearance).
- Previous treatments with TPO-R agonists (e.g., eltrombopag, romiplostim) at any time before screening or enrollment.
- Platelet transfusion received within 72 hours prior to screening or enrollment, with PC >75×109/L at screening or enrollment.
- Known or expected allergy or intolerance to the active substances or excipients of hetrombopag.
- Acute or chronic hepatitis C or hepatitis B.
- Human immunodeficiency virus (HIV) infection.
- Confirmed SARS-CoV-2 (COVID-19) infection (validated test positive), or suspected COVID-19 infection (clinical symptoms without documented test results) within 4 weeks before screening, or close contact with a person with known or suspected COVID-19 infection within 2 weeks before screening (subject may be included with a documented negative result for a validated COVID-19 test).
- Pregnancy/intention to become pregnant during the study period or lactation.
- Participation in another clinical trial within 30 days or 5 half-lives of an investigational product (whichever is longer) prior to screening.
- Investigator's judgement that participation in the study creates a significant risk for the health of a subject, or his/her condition may affect evaluation of the safety and/or efficacy of hetrombopag.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Two-Stage Phase Ⅲ Study Evaluating the Efficacy and Safety of Hetrombopag Olamine Tablets in Treatment of Chemotherapy-Induced Thrombocytopenia
The study is aimed to evaluate the efficacy of different doses of hetrombopag compared to placebo, measured by the proportion of subjects that can complete two planned consecutive chemotherapy cycles with no modification of chemotherapy regimen (i.e., delayed start, dose reduction, omission, or discontinuation) because of thrombocytopenia [platelet count <100×109/L], to determine an optimal dose of hetrombopag and to demonstrate its superiority over placebo.
- Conditions
- Chemotherapy-Induced Thrombocytopenia
- Being tested
- Hetrombopag, Matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HetrombopagDrug
Stage 1： Hetrombopag lower dose； Hetrombopag higher dose
Stage 2:
Hetrombopag X mg (dose to be determined based on Stage 1 results)
Matching placeboDrug
Matching placebo（Stage 1；Stage 2）
| Study group | Role | What they receive |
|---|---|---|
| Hetrombopag | Experimental | Not described Receives: Drug: Hetrombopag |
| Matching placebo | Placebo comparator | Not described Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of treatment "responders" who do not require modification of chemotherapy regimen because of thrombocytopenia (PC <100×109/L) during two planned consecutive chemotherapy cycles without the use of rescue treatment.
Cochran-Mantel-Haenszel (CMH) test will be used to make a comparison between each hetrombopag group and the placebo group.
Measured: 56 days after the first dose of study drug
Secondary outcomes (9)
Time to first platelet response, defined by PC ≥100×109/L.
Will be analyzed by a log-rank test stratified by the randomization stratification factors.
The Kaplan-Meier (KM) method will be used to describe the time-to-event data.
Measured: 56 days after the first dose of study drug
Proportion of subjects achieving PC ≥100×109/L.
Will be analyzed with the CMH test
Measured: 14 days after the first dose of study drug
Time duration of PC ≥100×109/L.
Will be analyzed with the log rank test and KM plots
Measured: 42 days after the start of the first chemotherapy cycle
PC nadir from the start of the first on-study chemotherapy cycle through the end of the double-blind treatment period.
An Analysis of Covariance (ANCOVA) will be used.
Measured: 42 days after the start of the first chemotherapy cycle]
Time duration of severe thrombocytopenia, defined as a PC of 50×109/L
Will be analyzed with the log rank test and KM plots.
Measured: 56 days after the first dose of study drug
Proportion of subjects without serious bleeding events, defined as grade ≥ 2, according to the World Health Organization Bleeding scale.
Will be analyzed with the CMH test.
Measured: 56 days after the first dose of study drug
Proportion of subjects with at least single incidence of platelet transfusion or other rescue treatment.
Will be analyzed with the CMH test.
Measured: 56 days after the first dose of study drug
Proportion of patients without chemotherapy regimen modifications due to any cause.
Will be analyzed with the CMH test.
Measured: 14 days after the first dose of study drug
Number adverse events (AEs) as assessed by CTCAE v5.0.
Arithmetic summary statistics will be provided.
Measured: up to 140 days of treatment with study drug plus 6 months of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start15 Apr 2022 (estimated)
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Why it stopped: Sponsor R \& D Strategy Adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261646
- Sponsor's protocol ID
- HR-TPO-CIT-301
- Status last verified
- Feb 2022
- First submitted
- 21 Feb 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Two-Stage Phase Ⅲ Study Evaluating the Efficacy and Safety of Hetrombopag Olamine Tablets in Treatment of Chemotherapy-Induced Thrombocytopenia
- ClinicalTrials.gov ID
- NCT05261646
- Acronym / sponsor ID
- HR-TPO-CIT-301
- Conditions
- Chemotherapy-Induced Thrombocytopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor R \& D Strategy Adjustment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2022 (estimated)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 2 Mar 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.
The study is aimed to evaluate the efficacy of different doses of hetrombopag compared to placebo, measured by the proportion of subjects that can complete two planned consecutive chemotherapy cycles with no modification of chemotherapy regimen (i.e., delayed start, dose reduction, omission, or discontinuation) because of thrombocytopenia [platelet count <100×109/L], to determine an optimal dose of hetrombopag and to demonstrate its superiority over placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hetrombopag | Experimental | Drug: Hetrombopag |
| Matching placebo | Placebo comparator | Drug: Matching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female gender, age ≥18 years.
- Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma [NSCLC], breast, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer).
- Receiving a chemotherapy cycle of 21 days with one or more of the following chemotherapeutic drugs:
- Delay for at least 1 week from the scheduled chemotherapy cycle because of thrombocytopenia (PC <75×109/L for 4 weeks after the start of the previous chemotherapy cycle.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Key exclusion criteria (27 listed)
- PC <25×109/L or ≥75 x 109/L at screening or enrollment.
- Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
- Hematologic malignancies.
- Thrombocytopenia caused by reasons other than chemotherapy, including but not limited to chronic liver disease, hypersplenism, infection, and hemorrhage, within 6 months before screening.
- Intracranial metastases or disease.
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 |
|---|---|---|
| HetrombopagStage 1： Hetrombopag lower dose； Hetrombopag higher dose Stage 2: Hetrombopag X mg (dose to be determined based on Stage 1 results) | Drug | Hetrombopag |
| Matching placeboMatching placebo（Stage 1；Stage 2） | Drug | Matching placebo |
Primary outcome
Proportion of treatment "responders" who do not require modification of chemotherapy regimen because of thrombocytopenia (PC <100×109/L) during two planned consecutive chemotherapy cycles without the use of rescue treatment.
Time frame: 56 days after the first dose of study drug
Cochran-Mantel-Haenszel (CMH) test will be used to make a comparison between each hetrombopag group and the placebo group.
9 secondary outcomes
Time to first platelet response, defined by PC ≥100×109/L.
Time frame: 56 days after the first dose of study drug
Proportion of subjects achieving PC ≥100×109/L.
Time frame: 14 days after the first dose of study drug
Time duration of PC ≥100×109/L.
Time frame: 42 days after the start of the first chemotherapy cycle
PC nadir from the start of the first on-study chemotherapy cycle through the end of the double-blind treatment period.
Time frame: 42 days after the start of the first chemotherapy cycle]
Time duration of severe thrombocytopenia, defined as a PC of 50×109/L
Time frame: 56 days after the first dose of study drug
Proportion of subjects without serious bleeding events, defined as grade ≥ 2, according to the World Health Organization Bleeding scale.
Time frame: 56 days after the first dose of study drug
Proportion of subjects with at least single incidence of platelet transfusion or other rescue treatment.
Time frame: 56 days after the first dose of study drug
Proportion of patients without chemotherapy regimen modifications due to any cause.
Time frame: 14 days after the first dose of study drug
Number adverse events (AEs) as assessed by CTCAE v5.0.
Time frame: up to 140 days of treatment with study drug plus 6 months of follow-up.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer
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A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia (ExCIT)
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hetrombopag in people with Chemotherapy-Induced Thrombocytopenia, run by Jiangsu HengRui Medicine Co., Ltd..
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 13 inclusion and 27 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: withdrawn, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of treatment "responders" who do not require modification of chemotherapy regimen because of thrombocytopenia (PC <100×109/L) during two planned consecutive chemotherapy cycles without the use of rescue treatment. (time frame: 56 days after the first dose of study drug). 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 28 Sep 2023.