Active — Not RecruitingPhase 3

Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Solid Tumors.

China213 participantsStarted 2023-04-25

Plain-language summary

The purpose of current study is to evaluate the efficacy and safety of hetrombopag for the treatment of chemotherapy-induced thrombocytopenia in patients with solid tumors.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Men and women, 18-75 years of age;
✓. Participant with a histologically or cytologically confirmed solid tumor receiving treatment with chemotherapeutic agents;
✓. Participant experienced thrombocytopenia and chemotherapy delay;
✓. ECOG performance status 0-1;
✓. Adequate Liver function; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3.0 x ULN for participants without liver metastases or 5.0 x ULN for participant with liver metastases);
✓. Adequate renal function; serum creatinine \< 1.5 x ULN or eGFR≤60 ml/min（Cockcroft-Gault）

Exclusion criteria

✕. Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
✕. Participant has serious bleeding symptoms;
✕. History of allergy to the study drug;
✕. Participant with HIV;
✕. Pregnant or lactating women;
✕. Participant has received any experimental therapy within 4 weeks prior to screening
✕. Other conditions that may affect participant's safety or trial evaluations per investigator's discretion

What they're measuring

The proportion of treatment responders.

Timeframe: Randomization up to 80 days

Trial details

NCT IDNCT05864014

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-03

View on ClinicalTrials.gov More Chemotherapy-Induced Thrombocytopenia trials