NCT00005402

Brief Summary

To identify a large cohort of children transfused in the decade prior to second-generation anti-hepatitis C virus (HCV) donor screening (1982-1992). This will not only identify cases for the study of persistent infection and chronic hepatitis in children, but will allow for the determination of the annualized risk of transfusion-associated hepatitis (TAH) infection in children, data that are not currently available.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started May 1996

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1996

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2000

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2001

Completed
Last Updated

December 17, 2015

Status Verified

April 1, 2002

Enrollment Period

4.9 years

First QC Date

May 25, 2000

Last Update Submit

December 16, 2015

Conditions

Eligibility Criteria

AgeUp to 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
No eligibility criteria

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Sponsors & Collaborators

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

May 1, 1996

Primary Completion

April 1, 2001

Study Completion

April 1, 2001

Last Updated

December 17, 2015

Record last verified: 2002-04