Recruiting
Phase 3

Hetrombopag Olamine

Sponsor:

Jiangsu HengRui Medicine Co., Ltd.

Code:

NCT07286032

Conditions

Patients With Chemotherapy-Induced Thrombocytopenia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hetrombopag Olamine

Hetrombopag Olamine; Hetrombopag Olamine Placebo

Study Details

Brief summary:

The ExCIT study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.

Conditions

Patients With Chemotherapy-Induced Thrombocytopenia

Study ID

NCT07286032

Start date

Apr 16, 2026

Status verified date

Sep, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female, 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 14- or 21-day treatment cycles.
4. Platelet count < 85 x 109/L at enrollment.
5. For Part B, experiencing a chemotherapy delay of ≥ 7 days due to CIT.
6. At least 2 scheduled chemotherapy cycles of the same treatment regimen as was used prior to enrollment.
7. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
8. Life expectancy ≥6 months.
9. Signed ICF for voluntary participation in the study and good compliance.

Exclusion Criteria:

1. WHO Grade ≥ 2 bleeding within 14 days prior to screening.
2. Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
3. Hematologic malignancies.
4. 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.
5. Untreated brain metastases; or with leptomeningeal metastasis.
6. Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
7. Severe cardiovascular disorders or interventions within 6 months.
8. Have arterial/venous thrombosis with anticoagulation not tolerated for at least 6 weeks.
9. Known bleeding disorders, platelet dysfunction.
10. Severe haemorrhage during screening (e.g., gastrointestinal or intracranial hemorrhage) within 28 days prior to enrolment.
11. Previous treatment with thrombopoietin receptor agonists (TPO-RAs) within 14 days prior to enrolment.
12. Platelet transfusion within 72 hours prior to enrollment.
13. Acute or uncontrolled hepatitis B\&C infection.
14. Human immunodeficiency virus (HIV) infection.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: Hetrombopag Olamine

experimental: Part B: Hetrombopag Olamine vs Hetrombopag Olamine Placebo

Interventions

Hetrombopag Olamine

For Part A, all participants would receive hetrombopag treatment.

Hetrombopag Olamine; Hetrombopag Olamine Placebo

For Part B, participants would be randomized to receive hetrombopag treatment or matching placebo, respectively.

Primary outcome measure

  • Part A: Cmax of hetrombopag in non-Asian participants with CIT, around 6 months. [ Time Frame: around 6 months. ]
  • Part A: AUC0-tauof hetrombopag in non-Asian participants with CIT, around 6 months. [ Time Frame: around 6 months. ]
  • Part A: Cmin of hetrombopag in non-Asian participants with CIT, around 6 months. [ Time Frame: around 6 months. ]
  • Part B: A platelet count of ≥100×109/L within 14 days after initiating the investigational product treatment, around 3 years. [ Time Frame: around 3 years. ]
  • Part B: No use of any rescue therapy for thrombocytopenia during the treatment period from the initiation of investigational product treatment until the end of the primary treatment period, around 3 years. [ Time Frame: 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. [ Time Frame: around 3 years. ]

Central Contacts and Locations

Locations

Cancer and Blood Specialty Clinic

Recruiting

Los Alamitos, California, United States, 90254

Principal Investigator:

Arati Chand

UCLA

Recruiting

Los Angeles, California, United States, 90095

Principal Investigator:

Wanxing Chai-Ho

Clermont Oncology Center

Recruiting

Clermont, Florida, United States, 34711

Principal Investigator:

Kunta Kunta

Oncology & Hematology Associates of West Broward

Recruiting

Coral Springs, Florida, United States, 33065

Principal Investigator:

Sumit Sawhney

Mid-Florida Hematology & Oncology Centers, P.A.

Recruiting

Orange City, Florida, United States, 32763

Principal Investigator:

Santosh Nair

Springfield Clinic

Recruiting

Springfield, Illinois, United States, 62702

Principal Investigator:

Preet Singh

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Principal Investigator:

Naomi Fei

Cancer Partners of Nebraska

Recruiting

Lincoln, Nebraska, United States, 68516

Principal Investigator:

Irfan Vaziri

More Information

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Jiangsu HengRui Medicine Co., Ltd. on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.