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ACTIVE_NOT_RECRUITINGPHASE3

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

Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Hetrombopag for the Treatment of Chemotherapy-induced Thrombocytopenia in Adults With Solid Tumors.

NCT05864014•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

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

Locations (1)

Hematology Tumor Research Center of Harbin First Hospital

Haerbin, Heilongjiang, China

Key Dates

Start Date

April 25, 2023

Primary Completion Date

March 3, 2025

Completion Date

September 1, 2025

Last Updated

April 16, 2025

Enrollment

213

ACTUAL participants

Conditions

Chemotherapy-Induced Thrombocytopenia

Interventions

Hetrombopag

DRUG

Hetrombopag plus Placebo

DRUG

Placebo

DRUG

Romiplostim N01 for Chemotherapy-induced Thrombocytopenia

NCT07063225

Chemotherapy-induced ThrombocytopeniaRomiplostim N01

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UNKNOWNPHASE3

Romiplostim in Chemotherapy-Induced Thrombocytopenia

NCT06201663

Chemotherapy-induced ThrombocytopeniaSolid Malignancy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Romiplostim N01 for Chemotherapy-induced Thrombocytopenia

Romiplostim in Chemotherapy-Induced Thrombocytopenia

The Efficacy and Safety of Hetrombopag as Secondary Prevention to Chemotherapy-induced Thrombocytopenia in Patients With Gynecologic Malignancies

Hetrombopag in Secondary Prevention of XPO-1 Inhibitor-induced Thrombocytopenia in Lymphoma

Evaluating the Efficacy and Safety of QL0911 in Chemotherapy- Induced Thrombocytopenia

A Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11