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OpenTrials
Completed

NCT Number: NCT03038763

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

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eligibility Screening

Other

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.

HCV test

Diagnostic 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.

Primary outcomes

  1. HCV prevalence

    Time frame: 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 outcomes

  1. Liver fibrosis

    Time frame: Within 2 weeks of diagnosis of HCV

    Level of liver fibrosis (detected through fibrosure test) found in adult children diagnosed as HCV-positive

  2. HCV genotype

    Time frame: Within 6 weeks of diagnosis of HCV

    HCV genotype for adult children diagnosed as HCV-positive

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Gilead Sciences

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 1, 2017
Registry last updated
Jul 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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