A Pharmacokinetics Study of MultiHance in Pediatric Patients | NCT00411931

Studies
A Pharmacokinetics Study of MultiHance in Pediatric Patients

NCT00411931

Sponsor

Bracco Diagnostics, Inc

Status

Completed

Last Update Posted

Jan 11, 2008Estimated

Enrollment

15Actual

Phase

Phase 1

Conditions

Central Nervous System Pathology

Interventions

Multihance

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Dec 13, 2006

First Submission Date that Met QC Criteria

Dec 14, 2006

First Posted Date

Dec 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2008

Last Update Posted Date

Jan 11, 2008Estimated

Description Module

Brief Summary

Compare relative exposure in the younger age group in order to supplement the PK profile already determined in older children and adults

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Name	Type	Description	Arm Group Labels	Other Names
Multihance	Drug	0.5M administered as a single injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess the blood PK of Multihance in patients from 2 to 5 years of age		up to 24 hours post dose

Secondary Outcomes

Measure	Description	Time Frame
Evaluate the safety of Multihance in patients from 2 to 5 years of age		through 72 hours post dose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female between 2 and 5 years of age
Obtained informed consent from patient's parent or guardian
Obtain assent when applicable according to local law
Known or suspected disease of the central nervous system (brain or spine)
Referred for MRI of the brain or spine requiring an injection of an MR contrast agent

Exclusion Criteria:

Contraindications to MR examination
Undergoing MRI in an emergency situation
Known allergy to one or more ingredients in the contrast agent or history of hypersensitivity to gadolinium or metals
Sickle cell anemia
Likely to undergo an invasive examination within 72 hours after administration of the investigational product

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gianpaolo Pirovano, M. D.	Bracco Diagnostics, Inc	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Krakow			Poland

Intervention Browse Module

MeSH Terms

ID	Term
C064572	gadobenic acid

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided