CompletedPhase 3

Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy.

China129 participantsStarted 2019-11-06

Plain-language summary

Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Hetrombopag in subjects with chemotherapy-induced thrombocytopenia receiving chemotherapy for the treatment of 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 confirmed diagnosis of solid tumor receiving a chemotherapy regimen;
✓. Participant experienced thrombocytopenia and chemotherapy delay;
✓. ECOG performance status 0-1;

Exclusion criteria

✕. Screening and baseline platelet count\< 30×109/L;
✕. Participant has experienced thrombocytopenia due to any etiology other than chemotherapy within 6 months of screening;
✕. Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
✕. Participant has serious bleeding symptoms;
✕. Participant has no hepatic metastases, ALT/AST\>3ULN, TBIL\>3ULN; with hepatic metastases, ALT/AST≥5ULN, TBIL≥5ULN;
✕. Blood Cr≥1.5ULN or eGFR≤60 ml/min（Cockcroft-Gault）;
✕. History of allergy to the study drug;
✕. Participant with HIV;

What they're measuring

The proportion of treatment responders.

Timeframe: Randomization up to 90 days

Trial details

NCT IDNCT03976882

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-22

View on ClinicalTrials.gov More Chemotherapy-Induced Thrombocytopenia trials