ThrombocytopeniaPhase 4NCT06562738
Clinical Study on Efficacy and Safety of Hetrombopag in the Preoperative Patients of Thrombocytopenia
A Phase 4 study testing Hetrombopag in people with Thrombocytopenia, run by The Third People's Hospital of Chengdu at 1 site in China.
Trial summary
This is an investigator-initiated, single-arm, prospective clinical study to evaluate the efficacy and safety of heptapopal in the treatment of thrombocytopenia prior to elective surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- Hetrombopag
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 Mar 2025
- 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
- Age ≥18 years old; diagnosis of immune thrombocytopenia.
- Platelets ≤75×10^9/L before scheduled elective surgery.
Who cannot join
- History of allergy to Thrombopoietin Receptor Agonists (TPO-RA) drugs;
- Severe bleeding symptoms, such as gastrointestinal bleeding, bleeding of important organs, and intracranial bleeding;
- Thrombotic diseases, such as pulmonary embolism, arterial thrombosis and disseminated intravascular coagulation (DIC);
- Positive anti-human immunodeficiency virus antibody or anti-treponema pallidum specific antibody;
- New York Heart Association (NYHA) Grade 3 or 4 congestive heart failure;
- History of angina pectoris, myocardial infarction or cerebral infarction within 6 months before the screening period;
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- Have an active infection that is difficult to control;
- Pregnant or lactating women;
- Other conditions determined by the investigator to be unsuitable for inclusion in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chengdu Third People's Hospital
Chengdu, Sichuan, 610000
Jing Tan, PhD, +86 028 61318717, tanjing@nsmc.edu.cn
About this study
This is an investigator-initiated, single-arm, prospective clinical study to evaluate the efficacy and safety of heptapopal in the treatment of thrombocytopenia prior to elective surgery
Read the detailed description
It was planned to include 55 patients with immune thrombocytopenia with preoperative platelet ≤75×10^9/L. After signing the informed consent letter, the patients will enter the screening period (up to 7 days), and after passing the screening, they will receive oral hexapopal treatment, the specific medication regimen is: 7.5mg, once a day, taken orally on an empty stomach before going to bed, for a maximum of 14 days, and stop the drug when PLT≥100×10^9/L. During the oral administration of hexapopal, the administration was suspended when PLT≥200×10^9/L, and continued when the blood image was monitored weekly until PLT < 100×10^9/L. During the treatment period, blood routine was monitored every 7 days, and when PLT≤30×10^9/L or ≥300×10^9/L, blood routine was monitored every 3 days. Patients will have an end-of-treatment visit within 7 days of stopping treatment, followed by a 30-day safe follow-up period.
- Conditions
- Thrombocytopenia
- Being tested
- Hetrombopag
- Keywords
- Hetrombopag, Thrombocytopenia, Preoperative
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HetrombopagDrug
Hetrombopag 7.5 mg, once a day, at bedtime for up to 14 days, drug administration was stopped when PLT≥100 ×10^9/L, and take blood routine examination weekly, drug administration was resumed when PLT < 100 ×10^9/L. When PLT ≤30× 10^9/L or ≥300 ×10^9/L, take blood routine examination every 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Hetrombopag arm | Experimental | Takes Hetrombopag 7.5 mg/day at bedtime for at most 14 days. Receives: Drug: Hetrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet elevation
Proportion of patients achieving perioperative platelet count goals (≥80×10^9/ L for major surgery and ≥50×10^9/ L for minor surgery) without emergency treatment
Measured: up to 14 days
Secondary outcomes (1)
Secondary Outcome
The median time to reach the platelet count target;
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Jun 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third People's Hospital of Chengdu
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of North Sichuan Medical College
- Responsible party
- Principal investigator, Ying Li, The Third People's Hospital of Chengdu
- Investigators
- JING TAN, MD, Principal investigator, 成都市第三人民医院
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562738
- Sponsor's protocol ID
- ThirdHospitalChengdu
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Efficacy and Safety of Hetrombopag in the Preoperative Patients of Thrombocytopenia
- ClinicalTrials.gov ID
- NCT06562738
- Acronym / sponsor ID
- ThirdHospitalChengdu
- Conditions
- Thrombocytopenia
- Keywords
- Hetrombopag, Thrombocytopenia, Preoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- The Third People's Hospital of ChengduUniversity, hospital or other
- Collaborators
- Affiliated Hospital of North Sichuan Medical College
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 20 Aug 2024 (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.
This is an investigator-initiated, single-arm, prospective clinical study to evaluate the efficacy and safety of heptapopal in the treatment of thrombocytopenia prior to elective surgery
Detailed description
It was planned to include 55 patients with immune thrombocytopenia with preoperative platelet ≤75×10^9/L. After signing the informed consent letter, the patients will enter the screening period (up to 7 days), and after passing the screening, they will receive oral hexapopal treatment, the specific medication regimen is: 7.5mg, once a day, taken orally on an empty stomach before going to bed, for a maximum of 14 days, and stop the drug when PLT≥100×10^9/L. During the oral administration of hexapopal, the administration was suspended when PLT≥200×10^9/L, and continued when the blood image was monitored weekly until PLT < 100×10^9/L. During the treatment period, blood routine was monitored every 7 days, and when PLT≤30×10^9/L or ≥300×10^9/L, blood routine was monitored every 3 days. Patients will have an end-of-treatment visit within 7 days of stopping treatment, followed by a 30-day safe follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Hetrombopag arm | Experimental | Drug: HetrombopagTakes Hetrombopag 7.5 mg/day at bedtime for at most 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 years old; diagnosis of immune thrombocytopenia.
- Platelets ≤75×10^9/L before scheduled elective surgery.
Key exclusion criteria (9 listed)
- History of allergy to Thrombopoietin Receptor Agonists (TPO-RA) drugs;
- Severe bleeding symptoms, such as gastrointestinal bleeding, bleeding of important organs, and intracranial bleeding;
- Thrombotic diseases, such as pulmonary embolism, arterial thrombosis and disseminated intravascular coagulation (DIC);
- Positive anti-human immunodeficiency virus antibody or anti-treponema pallidum specific antibody;
- New York Heart Association (NYHA) Grade 3 or 4 congestive heart failure;
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 7.5 mg, once a day, at bedtime for up to 14 days, drug administration was stopped when PLT≥100 ×10^9/L, and take blood routine examination weekly, drug administration was resumed when PLT < 100 ×10^9/L. When PLT ≤30× 10^9/L or ≥300 ×10^9/L, take blood routine examination every 3 days. | Drug | Experimental: Hetrombopag arm |
Primary outcome
Platelet elevation
Time frame: up to 14 days
Proportion of patients achieving perioperative platelet count goals (≥80×10^9/ L for major surgery and ≥50×10^9/ L for minor surgery) without emergency treatment
1 secondary outcome
Secondary Outcome
Time frame: up to 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: Yes
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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.
JING TAN, MD principal investigator
成都市第三人民医院
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 in people with Thrombocytopenia, run by The Third People's Hospital of Chengdu 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 2 inclusion and 9 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 20 Aug 2024. 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?
Contact Ying Li, PhD (+86 028 61318717, 79468064@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet elevation (time frame: up to 14 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 20 Aug 2024.