Pediatric Liver Database | NCT00677625

Studies
Pediatric Liver Database

NCT00677625

Sponsor

Medical College of Wisconsin

Status

Completed

Last Update Posted

Nov 17, 2017Actual

Enrollment

401Actual

Phase

Not provided

Conditions

Liver Disease
Liver Transplant

Interventions

Not provided

Countries

United States

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

Nov 2017

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

Jun 2003

Primary Completion Date

Sep 15, 2016Actual

Completion Date

Sep 15, 2016Actual

First Submitted Date

May 9, 2008

First Submission Date that Met QC Criteria

May 9, 2008

First Posted Date

May 14, 2008Estimated

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

Nov 15, 2017

Last Update Posted Date

Nov 17, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Grzegorz Telega, Associate Professor of Pediatrics, Medical College of WisconsinPrincipal Investigator

Lead Sponsor

Medical College of WisconsinOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to collect data to examine and characterize the clinical outcomes of pediatric patients diagnosed with any liver disease at Children's Hospital of Wisconsin.

Detailed Description

In this study, medical information which is routinely obtained on children with any liver diseases, or children who have had a liver transplant will be entered into a database. No extra tests are done for participating in this study, and no extra visits to the doctor are required. The clinical data collected is then entered into a database and followed longitudinally. The information obtained from this study will help researchers learn more about pediatric liver disease, therefore providing better routine clinical treatment.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

401Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liver Disease (LD)		These child subjects have some form of liver disease (including those who need a liver transplant) or have already had a liver transplant.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Under 18 years of age
newly diagnosed with a liver disease, currently listed for liver transplant, or who are being considered for liver transplantation and evaluated
receive a liver transplant prior to their eighteenth birthday

Exclusion Criteria:

Patients decline participation.
Patients have no liver diseases.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

All child subjects will be recruited from the Hepatology Clinic at Children's Hospital of Wisconsin

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Grzegorz Telega, MD	Medical College of Wisconsin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Wisconsin		Milwaukee	Wisconsin	53226	United States