Vertical Transmission of Hepatitis C in Adult Children of Female Baby Boomers

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT03038763

Collaborator

Gilead Sciences (Industry)

100

Enrollment

Location

25.6

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators aim to determine the prevalence of hepatitis C in the adult children of female baby boomers. During the years baby boomers were becoming pregnant, hepatitis C testing was either not available or was not standard of care. Because of this, participants' children may be unaware of participants' risk of hepatitis C.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Hepatitis C, Chronic	Other: Eligibility Screening Diagnostic Test: HCV test

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Vertical Transmission of Hepatitis C in Adult Children of Female Baby Boomers

Actual Study Start Date :

May 11, 2017

Actual Primary Completion Date :

Jun 30, 2019

Actual Study Completion Date :

Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Mothers Black or white mothers who have or have had hepatitis C and were born between 1945-1964. Participants must have at least one child over the age of 18.	Other: Eligibility Screening Investigators will call eligible mothers to screen for the possibility that eligible mothers may have passed HCV on to adult children. Investigators will consent these mothers to contact the adult child(ren), as the child(ren) must be informed of the mother's HCV status, if not already known.
Adult Children Adult children of Black or white mothers who have or have had hepatitis C and were born between 1945-1964. From speaking with these mothers, it must be possible that participants were exposed to hepatitis C virus while in the womb.	Diagnostic Test: HCV test Adult children will be invited to Penn or a Penn affiliate to have labwork, testing HCV antibody and HCV quant. If the quant comes back positive, investigators will also test genotype and fibrosure.

Arm

Intervention/Treatment

Mothers

Black or white mothers who have or have had hepatitis C and were born between 1945-1964. Participants must have at least one child over the age of 18.

Other: Eligibility Screening

Investigators will call eligible mothers to screen for the possibility that eligible mothers may have passed HCV on to adult children. Investigators will consent these mothers to contact the adult child(ren), as the child(ren) must be informed of the mother's HCV status, if not already known.

Adult Children

Adult children of Black or white mothers who have or have had hepatitis C and were born between 1945-1964. From speaking with these mothers, it must be possible that participants were exposed to hepatitis C virus while in the womb.

Diagnostic Test: HCV test

Adult children will be invited to Penn or a Penn affiliate to have labwork, testing HCV antibody and HCV quant. If the quant comes back positive, investigators will also test genotype and fibrosure.

Outcome Measures

Primary Outcome Measures

HCV prevalence [Within 1 week of labwork at first study visit]
Prevalence of HCV in adult children of female baby boomers who have or have had HCV

Secondary Outcome Measures

Liver fibrosis [Within 2 weeks of diagnosis of HCV]
Level of liver fibrosis (detected through fibrosure test) found in adult children diagnosed as HCV-positive
HCV genotype [Within 6 weeks of diagnosis of HCV]
HCV genotype for adult children diagnosed as HCV-positive

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 72 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Mothers:

Born between 1/1/45-12/31/64
Black or white race
Active or prior infection with hepatitis C
Have at least one living adult child over the age of 18

Children:

≥18 years of age
Born to mother with current or prior HCV infection, with likely timing of HCV acquisition prior to or during pregnancy
Mother gave informed consent for child to be approached for study participation

Exclusion Criteria:

Mothers:

Unwilling to disclose hepatitis C status to children

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

University of Pennsylvania
Gilead Sciences

Investigators

Principal Investigator: David Goldberg, MD, MSCE, University of Pennsylvania Perelman School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT03038763

Other Study ID Numbers:

826229

First Posted:

Feb 1, 2017

Last Update Posted:

Jul 17, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 17, 2019