NCT04005066

A Phase IV Study of Elunate® (Fruquintinib) in Chinese Patients

A Post-Marketing Clinical Study to Evaluate the Safety of Elunate® (Fruquintinib Capsules) in Chinese Patients.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,005 (actual)
• Sponsor: Hutchmed · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A phase IV study to characterize safety of Elunate® (Fruquintinib) in Chinese patients

Detailed description

This study is a prospective, open-label, multi-center, study design to obtain the safety information of participant after medication. The follow-up time points for each participant include first time signing the informed consent form,1 month after signing the informed consent form, 6 months after signing the informed consent form or 30 days after the last dose (whichever occurs first).

Conditions

• Patient Safety

Interventions

Type	Name	Description
DRUG	Elunate®	The recommended dose is 5 mg once daily (1 capsule, each capsule contains 5 mg of fruquintinib); three weeks of continuous drug administration followed by one week of drug free period (4 weeks as one treatment cycle).

Timeline

• Start date: 2019-04-20
• Primary completion: 2022-09-27
• Completion: 2022-09-27
• First posted: 2019-07-02
• Last updated: 2022-12-19

Locations

1 site across 1 country: China