NCT00924248

Brief Summary

The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,358

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2007

Typical duration 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

Study Start

First participant enrolled

October 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

September 19, 2012

Status Verified

September 1, 2012

First QC Date

June 17, 2009

Last Update Submit

September 18, 2012

Conditions

Liver

Keywords

Liver MRI

Outcome Measures

Primary Outcomes (1)

  • Safety evaluation in real practice (SAE/AE/ADR collection)

    After administration

Secondary Outcomes (3)

  • Assessment of contrast effect by imaging after administration

    Before administration

  • Overall contrast effects by combining individual assessment

    Before administration

  • Assessment of contrast enhancement effect

    After administration

Study Arms (1)

Group 1

Drug: Gadoxetic acid disodium (Primovist, BAY86-4873)

Interventions

Gadoxetic acid disodium (Primovist, BAY86-4873)DRUG

Patients in daily life clinical practice treatment receiving Primovist according to indication on the label.

Group 1

Eligibility Criteria

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

Korean who take Primovist for liver MRI

You may qualify if:

  • Patient who take Primovist for liver MRI

You may not qualify if:

  • Patients who belong to the contraindication on the product label

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, South Korea

Location

MeSH Terms

Interventions

gadolinium ethoxybenzyl DTPA

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 17, 2009

First Posted

June 18, 2009

Study Start

October 1, 2007

Study Completion

May 1, 2011

Last Updated

September 19, 2012

Record last verified: 2012-09

Locations

KR(1)