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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03038763
Enrollment
100
Registered
2017-02-01
Start date
2017-05-11
Completion date
2019-06-30
Last updated
2019-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Hepatitis C, Chronic

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.

Interventions

OTHEREligibility 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.

DIAGNOSTIC_TESTHCV 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.

Sponsors

Gilead Sciences
CollaboratorINDUSTRY
University of Pennsylvania
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 72 Years
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

Design outcomes

Primary

MeasureTime frameDescription
HCV prevalenceWithin 1 week of labwork at first study visitPrevalence of HCV in adult children of female baby boomers who have or have had HCV

Secondary

MeasureTime frameDescription
Liver fibrosisWithin 2 weeks of diagnosis of HCVLevel of liver fibrosis (detected through fibrosure test) found in adult children diagnosed as HCV-positive
HCV genotypeWithin 6 weeks of diagnosis of HCVHCV genotype for adult children diagnosed as HCV-positive

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026