NCT01205243

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
671

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 17, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2015

Completed
Last Updated

June 19, 2018

Status Verified

June 1, 2018

Enrollment Period

4.3 years

First QC Date

September 17, 2010

Last Update Submit

June 18, 2018

Conditions

Infection, Human Immunodeficiency Virus I

Keywords

Abacavirpost-marketing surveillance

Outcome Measures

Primary Outcomes (1)

  • Occurrence of adverse event after ZIAGEN® administration

    12month

Secondary Outcomes (3)

  • Occurrence of serious adverse event after ZIAGEN® administration

    12month

  • efficacy after ZIAGEN® administration

    12month

  • Occurrence of unexpected adverse drug reaction after ZIAGEN® administration

    12 month

Study Arms (1)

ZIAGEN®

Patients administrated ZIAGEN® at the site

Drug: ZIAGEN®

Interventions

ZIAGEN®DRUG

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.

ZIAGEN®

Eligibility Criteria

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

Patients administrated ZIAGEN® at the site

You may not qualify if:

  • Subjects with hypersensitivity to ZIAGEN® or ingredients
  • Subjects with moderate or severe hepatic impairment
  • Subject with end-stage renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Incheon, 400-711, South Korea

Location

MeSH Terms

Conditions

Infections

Interventions

abacavir

Study Officials

  • GSK Clinical Trials

    ViiV Healthcare

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 17, 2010

First Posted

September 20, 2010

Study Start

November 1, 2010

Primary Completion

February 1, 2015

Study Completion

February 5, 2015

Last Updated

June 19, 2018

Record last verified: 2018-06

Locations

KR(1)