Clinical Trials Logo
  1. Home
  2. Patient Safety
  3. NCT04005066
  4. Details
NCT04005066 Clinical Trial

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

Patient Safety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04005066
Other study ID # 2018-013-00CH2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 20, 2019
Est. completion date September 27, 2022

Study information
Verified date December 2022
Source Hutchmed
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Completed
Enrollment 3005
Est. completion date September 27, 2022
Est. primary completion date September 27, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Currently using Elunate®(Fruquintinib) or will use Elunate®(Fruquintinib) within a week; - Provision of informed consent by the patient. Exclusion Criteria: • Unsuitable for the study according to investigator's judgement.

Study Design

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
China Shanghai Dongfang Hospital Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Hutchmed

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of AEs % of patients with AEs according to CTCAE 4.03 from the first administration of fruquintinib up to 6 months
Primary Incidence of ADRs % of patients with ADRs according to CTCAE 4.03 from the first administration of fruquintinib up to 6 months
Primary Incidence of SAEs % of patients with SAEs according to CTC AE 4.03 from the first administration of fruquintinib up to 6 months
Primary Incidence of AESI % of patients with AESI according to CTC AE 4.03 from the first administration of fruquintinib up to 6 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06043895 - EpiFaith CV for Central Venous Catheterization N/A
Not yet recruiting NCT05958108 - Effectivenness and Implementation of an Intervention to Improve Primary Care Patient Safety Phase 3
Recruiting NCT02574104 - Generalizing TESTPILOT to New Single Family Room NICUs N/A
Completed NCT00599209 - Health Information Technology in the Nursing Home N/A
Completed NCT04576299 - Health Care Workers' Perception of Patient Safety During COVID-19 Pandemic
Completed NCT03663491 - Necessity of Transnasal Gastroscopy in Routine Diagnostics - a Patient Centered Requirement Analysis N/A
Completed NCT00212927 - Continuity of Care and Outcomes After Discharge From Hospital N/A
Not yet recruiting NCT05062434 - An Intervention to Impact Cardiovascular Implantable Electronic Device Lead Models Implanted in Veterans N/A
Recruiting NCT06089239 - De-Implementing Fall Prevention Alarms in Hospitals N/A
Recruiting NCT04861025 - Siderails as a Measure of Physical Restraint. GERBAR Trial
Completed NCT04990986 - Co-Development and Evaluation of a Complex Intervention to Increase Medication Safety in Nursing Homes N/A
Recruiting NCT02955836 - Effectiveness of Monitoring Information System of Nursing Related Patient Safety and Quality Indicators N/A
Completed NCT01246544 - Helsinki Declaration on Patient Safety N/A
Recruiting NCT05530187 - ePRO-based Model of Care to Manage and Monitoring Symptoms of Cancer Patients Treated With Immune Checkpoint Inhibitors N/A
Recruiting NCT04176094 - Intensive Care Unit Resident Scheduling Trial N/A
Completed NCT05794490 - Learning From Excellence in a Hospital Unit
Recruiting NCT06269250 - Acceptance and Perceived Benefits of Digitalization by Medical Assistants
Recruiting NCT03105713 - Development and Implementation of Patient Safety Checklists Before, During and After In-hospital Surgery N/A
Completed NCT04184570 - Audit of International Intraoperative Hemotherapy and Blood Loss Documentation
Recruiting NCT04897087 - Openness and Learning Joint Commission: Using Patient Experience for Improvement Following a Patient Safety Event