ZIAGEN® Post-marketing Surveillance
An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and efficacy of ZIAGEN® administered in Korean patients according to the prescribing information.
|Study Design:||Time Perspective: Prospective|
|Official Title:||An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Efficacy of ZIAGEN® Administered in Korean Patients According to the Prescribing Information|
- Occurrence of adverse event after ZIAGEN® administration [ Time Frame: 12month ] [ Designated as safety issue: No ]
- Occurrence of serious adverse event after ZIAGEN® administration [ Time Frame: 12month ] [ Designated as safety issue: No ]
- efficacy after ZIAGEN® administration [ Time Frame: 12month ] [ Designated as safety issue: No ]
- Occurrence of unexpected adverse drug reaction after ZIAGEN® administration [ Time Frame: 12 month ] [ Designated as safety issue: No ]
|Study Start Date:||November 2010|
|Study Completion Date:||February 2015|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Patients administrated ZIAGEN® at the site
Basically there is no treatment allocation. Subjects who would be administrated ZIAGEN® at their physician's discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.
This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of KFDA for market authorization.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205243
|Korea, Republic of|
|GSK Investigational Site|
|Incheon, Korea, Republic of, 400-711|
|Study Director:||GSK Clinical Trials||ViiV Healthcare|