Actively Recruiting
Clinical Study on Efficacy and Safety of Hetrombopag in Preoperative Patients with Thrombocytopenia
Led by The Third People's Hospital of Chengdu · Updated on 2024-08-20
55
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
T
The Third People's Hospital of Chengdu
Lead Sponsor
A
Affiliated Hospital of North Sichuan Medical College
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of Hetrombopag in adults with immune thrombocytopenia who have low platelet counts before scheduled elective surgery. This prospective, single-arm clinical study aims to understand how well Hetrombopag can increase platelet levels in this specific patient group. The study is sponsored by The Third People's Hospital of Chengdu and is planned for up to 55 participants. Participants will receive oral Hetrombopag at a dose of 7.5 mg once daily at bedtime on an empty stomach for up to 14 days. Treatment will be stopped when platelet counts reach 100 x 10^9/L and paused if counts rise to 200 x 10^9/L or higher. Blood tests will be done weekly during treatment and more frequently if platelet counts drop to 30 x 10^9/L or rise to 300 x 10^9/L. The study includes a screening period of up to 7 days before treatment and a 30-day safety follow-up after stopping the drug. During the study, participants will have regular blood tests every 7 days or every 3 days depending on platelet levels to monitor their response and safety. An end-of-treatment visit will take place within 7 days after stopping medication. Researchers will measure platelet elevation over up to 14 days as the primary outcome. All participants will be monitored for safety during the follow-up period, which lasts 30 days after treatment ends.
CONDITIONS
Brief Title
Clinical Study on Efficacy and Safety of Hetrombopag in the Preoperative Patients of Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with immune thrombocytopenia
- Platelet count of 75 x 10^9/L or less before scheduled elective surgery
You will not qualify if you...
- Allergy history to Thrombopoietin Receptor Agonists (TPO-RA) drugs
- Severe bleeding symptoms such as gastrointestinal, organ, or intracranial bleeding
- Thrombotic diseases including pulmonary embolism, arterial thrombosis, and disseminated intravascular coagulation
- Positive for HIV antibody or anti-treponema pallidum antibody
- New York Heart Association Grade 3 or 4 congestive heart failure
- History of angina, myocardial infarction, or cerebral infarction within 6 months before screening
- Active infection that is difficult to control
- Pregnant or breastfeeding women
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - Up to 7 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days
Participants take Hetrombopag 7.5 mg orally once daily at bedtime on an empty stomach for up to 14 days. Drug administration is stopped when platelet count reaches 100 ×10⁹/L or higher, suspended if platelet count reaches 200 ×10⁹/L or higher, and resumed if platelet count falls below 100 ×10⁹/L. Blood routine is monitored weekly during treatment, and more frequently every 3 days if platelet counts are ≤30 ×10⁹/L or ≥300 ×10⁹/L.
Weekly visits for blood monitoring, with additional visits every 3 days if platelet counts are very low or very high
Duration - Within 7 days after treatment stops
Participants have an end-of-treatment visit within 7 days after stopping the medication to assess their condition.
1 visit (in-person)
Duration - 30 days
Participants are monitored for safety for 30 days after the end of treatment.
Visits as needed for safety monitoring
Trial Site Locations
Total: 1 location
1
Chengdu Third People's Hospital
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
Y
Ying Li, PhD
Z
Zuofeng Liu, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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