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NCT Number: NCT07286032

A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia

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

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Key information

Conditions

Patients With Chemotherapy-Induced Thrombocytopenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cancer and Blood Specialty Clinic, Los Alamitos, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
  • Hematologic malignancies.
  • 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.
  • Untreated brain metastases; or with leptomeningeal metastasis.
  • Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
  • Severe cardiovascular disorders or interventions within 6 months
  • Have arterial/venous thrombosis within 6 months
  • Known bleeding disorders, platelet dysfunction
  • Severe haemorrhage during screening
  • Acute or uncontrolled hepatitis B&C infection
  • Human immunodeficiency virus (HIV) infection.

Treatment and study plan

Hetrombopag Olamine

Drug

For Part A, all participants would receive hetrombopag treatment.

Hetrombopag Olamine ；Hetrombopag Olamine Placebo

Drug

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

Primary outcomes

  1. Part A: Cmax of hetrombopag in non-Asian participants with CIT, around 6 months.

    Time frame: around 6 months.

  2. Part A: AUC0-tauof hetrombopag in non-Asian participants with CIT, around 6 months

    Time frame: around 6 months

  3. Part A: Cmin of hetrombopag in non-Asian participants with CIT, around 6 months

    Time frame: around 6 months

  4. 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

  5. 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.

  6. 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;

Secondary outcomes

  1. Proportion of participants achieving platelet count ≥100×109/L without the use of rescue therapy within 14 days after initiating the investigational product treatment,around 3 years;

    Time frame: around 3 years;

  2. platelet count nadir from Cycle 1 Day 1 until Cycle 2 Day 21, around 3 years;

    Time frame: around 3 years;

  3. Proportion of participants free from serious bleeding events, during the treatment period from the initiation of IP treatment until C2D21, around 3 years;

    Time frame: around 3 years;

  4. Proportion of participants with neutropenia during the treatment period from the initiation of IP treatment until Cycle 2 Day 21, around 3 years.

    Time frame: around 3 years.

  5. Number of Adverse Events/Serious Adverse Events, safety lab parameters, vital signs, etc within study period, around 3 years.

    Time frame: around 3 years.

Study contacts

Contact information is provided by the study sponsor or research team.

Junye Xiong

CONTACT

[email protected]

0518-82342973

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Dec 16, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.