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

Phase 3

Active, not recruiting

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

• Registration Number: NCT05864014
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-25
• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-17
• Study First Posted: 2023-05-18
• Primary Completion: 2025-03-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 213

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hetrombopag plus Placebo	Hetrombopag plus Placebo	-
Placebo	Placebo	-
Hetrombopag	Hetrombopag	-

Primary Outcome Measures

Name	Time	Method
The proportion of treatment responders.	Randomization up to 80 days

Secondary Outcome Measures

Name	Time	Method
Duration from the commencement of treatment to a platelet count ≥100×109/L;	Randomization up to 30 days
Proportion of subjects who could complete chemotherapy without dose modification and rescue therapy and;	Randomization up to 160 days
Proportion of subjects without serious bleeding events;	Randomization up to 190 days
Number of adverse events (AEs)/serious adverse events (SAEs)	Randomization up to 190 days

Trial Locations

Locations (1)

Hematology Tumor Research Center of Harbin First Hospital; 🇨🇳 Haerbin, Heilongjiang, China