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 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

Dec, 2025

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 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.

Exclusion Criteria:

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.

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 Cycle 2 Day 21, 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

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

Recruiting

Orange City, Florida, United States, 32763

Principal Investigator:

Santosh Nair

More Information

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Last update posted

Jul 14, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jiangsu HengRui Medicine Co., Ltd. on 2026-07-14.