A Randomized, Multi-Center, Double-Blind, Phase III Study Evaluating the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male or female gender, age ≥18 years at screening.
• Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma \[NSCLC\], breast, ovarian, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer).
• Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 21-day treatment cycles.
• Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
• Life expectancy ≥6 months.
• Signed ICF for voluntary participation in the study and good compliance.
Locations
United States
California
Cancer and Blood Specialty Clinic
NOT_YET_RECRUITING
Los Alamitos
Colorado
AdventHealth Hematology and Oncology Denver Cypress Hematology and Oncology
NOT_YET_RECRUITING
Denver
Florida
Oncology & Hematology Associates of West Broward
NOT_YET_RECRUITING
Coral Springs
Mid-Florida Hematology & Oncology Centers, P.A.
RECRUITING
Orange City
Illinois
Springfield Clinic
NOT_YET_RECRUITING
Springfield
New Jersey
Morristown Medical Center
NOT_YET_RECRUITING
Morristown
New York
New York Cancer and Blood Specialists One Oncology
NOT_YET_RECRUITING
Shirley
Contact Information
Primary
Junye Xiong
junye.xiong@hengrui.com
0518-82342973
Time Frame
Start Date: 2026-04-16
Estimated Completion Date: 2029-06
Participants
Target number of participants: 150
Treatments
Experimental: Part A: Hetrombopag Olamine
Experimental: Part B：Hetrombopag Olamine vs Hetrombopag Olamine Placebo
Related Therapeutic Areas
Sponsors
Leads: Jiangsu HengRui Medicine Co., Ltd.