NCT02217761

Brief Summary

The purpose of this study is to investigate the factors influencing pharmacokinetic and pharmacodynamic properties of new antifungal agent, posaconazole in Taiwanese patients.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 15, 2014

Status Verified

August 1, 2014

Enrollment Period

5.3 years

First QC Date

August 13, 2014

Last Update Submit

August 13, 2014

Conditions

PharmacokineticsPosaconazole

Keywords

PharmacokineticsAntifungal Agents

Outcome Measures

Primary Outcomes (1)

  • Plasma posaconazole concentration

    7-10 days after taking posaconazole

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in National Taiwan University receiving posaconazole

You may qualify if:

  • Patients receiving posaconazole therapy
  • Patients aged 13 years old or more

You may not qualify if:

  • No posaconazole plasma concentration available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum. white cells, saliva

Study Officials

  • Shu-Wen Lin, Pharm. D.

    Graduate institute of clinical pharmacy at National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2014

First Posted

August 15, 2014

Study Start

March 1, 2012

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

August 15, 2014

Record last verified: 2014-08