A Study of Hetrombopag Olamine for Low Platelets Caused by Chemotherapy
This study is looking into a drug called Hetrombopag Olamine to see how well it works and if it's safe for people who have low platelet counts (thrombocytopenia) because of chemotherapy. In one part of the study (Part A), everyone will receive Hetrombopag Olamine. In another part (Part B), you would be randomly assigned to receive either Hetrombopag Olamine or a placebo (an inactive substance that looks like the drug). The study aims to enroll 150 participants who are at least 18 years old, have a solid tumor (like lung, breast, or colon cancer), and are receiving certain types of chemotherapy. Researchers will measure how much Hetrombopag Olamine is in your body over about 6 months to understand its effects.
- Study design
- This study is an interventional trial with a planned enrollment of 150 participants. In Part B, participants will be randomly assigned to receive either Hetrombopag Olamine or a placebo.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for Part A are measured around 6 months after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia
At a glance
Conditions
NCT07286032
Where you'd take part
This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
AdventHealth Hematology and Oncology Denver Cypress Hematology and Oncology
Denver, Coloradono site contact published
Not yet recruiting
Cancer and Blood Specialty Clinic
Los Alamitos, Californiano site contact published
Not yet recruiting
Mid-Florida Hematology & Oncology Centers, P.A.
Orange City, Floridano site contact published
Recruiting
Morristown Medical Center
Morristown, New Jerseyno site contact published
Not yet recruiting
New York Cancer and Blood Specialists One Oncology
Shirley, New Yorkno site contact published
Not yet recruiting
Oncology & Hematology Associates of West Broward
Coral Springs, Floridano site contact published
Not yet recruiting
Springfield Clinic
Springfield, Illinoisno site contact published
Not yet recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Part A: Cmax of hetrombopag in non-Asian participants with CIT, around 6 months.around 6 months.
- Part A: AUC0-tauof hetrombopag in non-Asian participants with CIT, around 6 monthsaround 6 months
- Part A: Cmin of hetrombopag in non-Asian participants with CIT, around 6 monthsaround 6 months
- Part B:A platelet count of ≥100×109/L within 14 days after initiating the investigational product treatment, around 3 yearsaround 3 years
- Part B:No use of any rescue therapy for thrombocytopenia during the treatment period from the initiation of investigational product treatment until Cycle 2 Day 21, around 3 years.around 3 years.
- Part B:Complete two consecutive on-study chemotherapy cycles (Cycle 1 and Cycle 2) without thrombocytopenia-induced modification of any myelosuppressive agent, around 3 years;around 3 years;