Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Alamitos, California and other locations
Dates
study started
study ends around

Description

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.

Official Title

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

Keywords

Patients With Chemotherapy-Induced Thrombocytopenia, Hetrombopag Olamine

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Male or female gender, age ≥18 years at screening.
  2. Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma [NSCLC], breast, ovarian, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer).
  3. Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 21-day treatment cycles.
  4. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
  5. Life expectancy ≥6 months.
  6. Signed ICF for voluntary participation in the study and good compliance.

You CAN'T join if...

  1. Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
  2. Hematologic malignancies.
  3. Thrombocytopenia caused by reasons other than chemotherapy, including but not limited to chronic liver disease, hypersplenism, infection, and hemorrhage, within 6 months prior to Study Day 1.
  4. Untreated brain metastases; or with leptomeningeal metastasis.
  5. Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
  6. Severe cardiovascular disorders or interventions within 6 months
  7. Have arterial/venous thrombosis within 6 months
  8. Known bleeding disorders, platelet dysfunction
  9. Severe haemorrhage during screening
  10. Acute or uncontrolled hepatitis B&C infection
  11. Human immunodeficiency virus (HIV) infection.

Locations

  • Cancer and Blood Specialty Clinic not yet accepting patients
    Los Alamitos California 90254 United States
  • AdventHealth Hematology and Oncology Denver Cypress Hematology and Oncology not yet accepting patients
    Denver Colorado 80210 United States
  • Mid-Florida Hematology & Oncology Centers, P.A. accepting new patients
    Orange City Florida 32763 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Links
Sign up for this study
ID
NCT07286032
Phase
Phase 3 Chemotherapy-Induced Thrombocytopenia Research Study
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated