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A Clinical Study of Hetrombopag Olamine Tablets in Adults Receiving 21-day Cycles of Chemotherapy for Solid Tumours, Who Are Delayed for at Least 1 Week From Their Scheduled Cycle Because of Chemotherapy-induced Thrombocytopenia

NCT05261646 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2023-09-28

No results posted yet for this study

Summary

The study is aimed to evaluate the efficacy of different doses of hetrombopag compared to placebo, measured by the proportion of subjects that can complete two planned consecutive chemotherapy cycles with no modification of chemotherapy regimen (i.e., delayed start, dose reduction, omission, or discontinuation) because of thrombocytopenia \[platelet count \<100×109/L\], to determine an optimal dose of hetrombopag and to demonstrate its superiority over placebo.

Conditions

  • Chemotherapy-Induced Thrombocytopenia

Interventions

DRUG

Hetrombopag

Stage 1： Hetrombopag lower dose； Hetrombopag higher dose Stage 2: Hetrombopag X mg (dose to be determined based on Stage 1 results)

DRUG

Matching placebo

Matching placebo（Stage 1；Stage 2）

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-15
Primary Completion
2025-03-15
Completion
2025-12-15
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05261646 on ClinicalTrials.gov