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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Hetrombopag Olamine
  • Hetrombopag Olamine ;Hetrombopag Olamine Placebo

Treatment groups

150 Participants
are divided into 2 treatment groups