Chemotherapy-Induced ThrombocytopeniaPhase 3NCT05864014
Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Solid Tumors.
A Phase 3 study testing Hetrombopag in people with Chemotherapy-Induced Thrombocytopenia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of current study is to evaluate the efficacy and safety of hetrombopag for the treatment of chemotherapy-induced thrombocytopenia in patients with solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- 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
- 213 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2023to Sep 2025
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, 18-75 years of age;
- Participant with a histologically or cytologically confirmed solid tumor receiving treatment with chemotherapeutic agents;
- Participant experienced thrombocytopenia and chemotherapy delay;
- ECOG performance status 0-1;
- Adequate Liver function; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 x ULN for participants without liver metastases or 5.0 x ULN for participant with liver metastases);
- Adequate renal function; serum creatinine < 1.5 x ULN or eGFR≤60 ml/min（Cockcroft-Gault）
Who cannot join
- Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
- Participant has serious bleeding symptoms;
- History of allergy to the study drug;
- Participant with HIV;
- Pregnant or lactating women;
- Participant has received any experimental therapy within 4 weeks prior to screening
- Other conditions that may affect participant's safety or trial evaluations per investigator's discretion
Trial locations and contacts
1 site in 1 country.
China1 site
Hematology Tumor Research Center of Harbin First Hospital
Haerbin, Heilongjiang, 150000
About this study
Official title: Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Hetrombopag for the Treatment of Chemotherapy-induced Thrombocytopenia in Adults With Solid Tumors.
The purpose of current study is to evaluate the efficacy and safety of hetrombopag for the treatment of chemotherapy-induced thrombocytopenia in patients with solid tumors.
- Conditions
- Chemotherapy-Induced Thrombocytopenia
- Being tested
- Hetrombopag, Hetrombopag plus Placebo, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HetrombopagDrug
Hetrombopag
Hetrombopag plus PlaceboDrug
Hetrombopag plus Placebo
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Hetrombopag | Experimental | Not described Receives: Drug: Hetrombopag |
| Hetrombopag plus Placebo | Experimental | Not described Receives: Drug: Hetrombopag plus Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of treatment responders.
Measured: Randomization up to 80 days
Secondary outcomes (4)
Duration from the commencement of treatment to a platelet count ≥100×109/L;
Measured: Randomization up to 30 days
Proportion of subjects who could complete chemotherapy without dose modification and rescue therapy and;
Measured: Randomization up to 160 days
Proportion of subjects without serious bleeding events;
Measured: Randomization up to 190 days
Number of adverse events (AEs)/serious adverse events (SAEs)
Measured: Randomization up to 190 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start25 Apr 2023
- Primary completion3 Mar 2025
- Study completionSep 2025 (estimated)
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
- 213 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
- NCT05864014
- Sponsor's protocol ID
- SHR8735-301
- Status last verified
- Apr 2025
- First submitted
- 9 May 2023
- Last updated
- 16 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Hetrombopag for the Treatment of Chemotherapy-induced Thrombocytopenia in Adults With Solid Tumors.
- ClinicalTrials.gov ID
- NCT05864014
- Acronym / sponsor ID
- SHR8735-301
- Conditions
- Chemotherapy-Induced Thrombocytopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- Sep 2025 (estimated)
- First posted
- 18 May 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 purpose of current study is to evaluate the efficacy and safety of hetrombopag for the treatment of chemotherapy-induced thrombocytopenia in patients with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hetrombopag | Experimental | Drug: Hetrombopag |
| Hetrombopag plus Placebo | Experimental | Drug: Hetrombopag plus Placebo |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women, 18-75 years of age;
- Participant with a histologically or cytologically confirmed solid tumor receiving treatment with chemotherapeutic agents;
- Participant experienced thrombocytopenia and chemotherapy delay;
- ECOG performance status 0-1;
- Adequate Liver function; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 x ULN for participants without liver metastases or 5.0 x ULN for participant with liver metastases);
Key exclusion criteria (7 listed)
- Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
- Participant has serious bleeding symptoms;
- History of allergy to the study drug;
- Participant with HIV;
- Pregnant or lactating women;
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 |
|---|---|---|
| HetrombopagHetrombopag | Drug | Hetrombopag |
| Hetrombopag plus PlaceboHetrombopag plus Placebo | Drug | Hetrombopag plus Placebo |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
The proportion of treatment responders.
Time frame: Randomization up to 80 days
4 secondary outcomes
Duration from the commencement of treatment to a platelet count ≥100×109/L;
Time frame: Randomization up to 30 days
Proportion of subjects who could complete chemotherapy without dose modification and rescue therapy and;
Time frame: Randomization up to 160 days
Proportion of subjects without serious bleeding events;
Time frame: Randomization up to 190 days
Number of adverse events (AEs)/serious adverse events (SAEs)
Time frame: Randomization up to 190 days
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 16 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
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. 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 6 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 16 Apr 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. 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?
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?
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?
The proportion of treatment responders. (time frame: Randomization up to 80 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 16 Apr 2025.