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

Hengrui Medicine

Status and phase: Active, not recruiting; Phase 3

Conditions: Chemotherapy-Induced Thrombocytopenia

Treatments: Drug: Placebo; Drug: Hetrombopag; Drug: Hetrombopag plus Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05864014

SHR8735-301

Details and patient eligibility

About

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.

Enrollment: 213 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Men and women, 18-75 years of age;
2. Participant with a histologically or cytologically confirmed solid tumor receiving treatment with chemotherapeutic agents;
3. Participant experienced thrombocytopenia and chemotherapy delay;
4. ECOG performance status 0-1;
5. 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);
6. Adequate renal function; serum creatinine < 1.5 x ULN or eGFR≤60 ml/min（Cockcroft-Gault）

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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213 participants in 3 patient groups, including a placebo group

Hetrombopag

Experimental group

Treatment:

Drug: Hetrombopag

Hetrombopag plus Placebo

Experimental group

Treatment:

Drug: Hetrombopag plus Placebo

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo