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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05864014

Enrollment

213

Registered

2023-05-18

Start date

2023-04-25

Completion date

2025-09-30

Last updated

2025-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-Induced Thrombocytopenia

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.

Interventions

DRUGHetrombopag

Hetrombopag

DRUGHetrombopag plus Placebo

Hetrombopag plus Placebo

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
The proportion of treatment responders.	Randomization up to 80 days

Secondary

Measure	Time frame
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026