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

Phase 3

Completed

• Conditions: Chemotherapy-Induced Thrombocytopenia
• Interventions: Drug: Placebo; Drug: Hetrombopag

• Registration Number: NCT03976882
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-03
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-06
• Study Start: 2019-11-06
• Primary Completion: 2023-02-22
• Study Completion: 2023-02-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

1. Men and women, 18-75 years of age;
2. Participant with a confirmed diagnosis of solid tumor receiving a chemotherapy regimen;
3. Participant experienced thrombocytopenia and chemotherapy delay;
4. ECOG performance status 0-1;

Exclusion Criteria

1. Screening and baseline platelet count< 30×109/L;
2. Participant has experienced thrombocytopenia due to any etiology other than chemotherapy within 6 months of screening;
3. Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
4. Participant has serious bleeding symptoms;
5. Participant has no hepatic metastases, ALT/AST>3ULN, TBIL>3ULN; with hepatic metastases, ALT/AST≥5ULN, TBIL≥5ULN;
6. Blood Cr≥1.5ULN or eGFR≤60 ml/min（Cockcroft-Gault）;
7. History of allergy to the study drug;
8. Participant with HIV;
9. Pregnant or lactating women;
10. Other conditions that may affect participant's safety or trial evaluations per investigator's discretion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B：Placebo	Placebo	-
Group A：Hetrombopag	Hetrombopag	-

Primary Outcome Measures

Name	Time	Method
The proportion of treatment responders.	Randomization up to 90 days

Secondary Outcome Measures

Name	Time	Method
Duration from starting treatment to initiating chemotherapy and platelet count ≥100×109/L	Randomization up to 30 days
Proportion of subjects who can completion chemotherapy without rescue therapy and dose modification	Randomization up to 150 days
Proportion of subjects without serious bleeding event	Randomization up to 180 days
Number of subjects with any Adverse Event (AE) or Serious Adverse Event (SAE) graded by the investigator according to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), version 5.0	Randomization up to 180 days

Trial Locations

Locations (1)

Najing Bayi Hospital; 🇨🇳 Nanjing, Jiangsu, China