Vertical Transmission of Hepatitis C in Adult Children of Female Baby Boomers
NCT ID: NCT03038763
Last Updated: 2019-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2017-05-11
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
\- Unwilling to disclose hepatitis C status to children
18 Years
72 Years
ALL
Yes
Sponsors
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Gilead Sciences
INDUSTRY
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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David Goldberg, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Countries
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References
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Kabiri M, Jazwinski AB, Roberts MS, Schaefer AJ, Chhatwal J. The changing burden of hepatitis C virus infection in the United States: model-based predictions. Ann Intern Med. 2014 Aug 5;161(3):170-80. doi: 10.7326/M14-0095.
Mast EE, Hwang LY, Seto DS, Nolte FS, Nainan OV, Wurtzel H, Alter MJ. Risk factors for perinatal transmission of hepatitis C virus (HCV) and the natural history of HCV infection acquired in infancy. J Infect Dis. 2005 Dec 1;192(11):1880-9. doi: 10.1086/497701. Epub 2005 Oct 28.
Rein DB, Smith BD, Wittenborn JS, Lesesne SB, Wagner LD, Roblin DW, Patel N, Ward JW, Weinbaum CM. The cost-effectiveness of birth-cohort screening for hepatitis C antibody in U.S. primary care settings. Ann Intern Med. 2012 Feb 21;156(4):263-70. doi: 10.7326/0003-4819-156-4-201202210-00378. Epub 2011 Nov 4.
Voelker R. Birth cohort screening may help find hepatitis C cases. JAMA. 2012 Mar 28;307(12):1242. doi: 10.1001/jama.2012.337. No abstract available.
AASLD/IDSA HCV Guidance Panel. Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus. Hepatology. 2015 Sep;62(3):932-54. doi: 10.1002/hep.27950. Epub 2015 Aug 4. No abstract available.
Benova L, Mohamoud YA, Calvert C, Abu-Raddad LJ. Vertical transmission of hepatitis C virus: systematic review and meta-analysis. Clin Infect Dis. 2014 Sep 15;59(6):765-73. doi: 10.1093/cid/ciu447. Epub 2014 Jun 13.
Kuncio DE, Newbern EC, Johnson CC, Viner KM. Failure to Test and Identify Perinatally Infected Children Born to Hepatitis C Virus-Infected Women. Clin Infect Dis. 2016 Apr 15;62(8):980-5. doi: 10.1093/cid/ciw026. Epub 2016 Jan 20.
Poynard T, Imbert-Bismut F, Munteanu M, Messous D, Myers RP, Thabut D, Ratziu V, Mercadier A, Benhamou Y, Hainque B. Overview of the diagnostic value of biochemical markers of liver fibrosis (FibroTest, HCV FibroSure) and necrosis (ActiTest) in patients with chronic hepatitis C. Comp Hepatol. 2004 Sep 23;3(1):8. doi: 10.1186/1476-5926-3-8.
Poynard T, Imbert-Bismut F, Munteanu M, Ratziu V. FibroTest-FibroSURE: towards a universal biomarker of liver fibrosis? Expert Rev Mol Diagn. 2005 Jan;5(1):15-21. doi: 10.1586/14737159.5.1.15.
Patel K, Benhamou Y, Yoshida EM, Kaita KD, Zeuzem S, Torbenson M, Pulkstenis E, Subramanian GM, McHutchison JG. An independent and prospective comparison of two commercial fibrosis marker panels (HCV FibroSURE and FIBROSpect II) during albinterferon alfa-2b combination therapy for chronic hepatitis C. J Viral Hepat. 2009 Mar;16(3):178-86. doi: 10.1111/j.1365-2893.2008.01062.x. Epub 2008 Oct 24.
Sebastiani G, Castera L, Halfon P, Pol S, Mangia A, Di Marco V, Pirisi M, Voiculescu M, Bourliere M, Alberti A. The impact of liver disease aetiology and the stages of hepatic fibrosis on the performance of non-invasive fibrosis biomarkers: an international study of 2411 cases. Aliment Pharmacol Ther. 2011 Nov;34(10):1202-16. doi: 10.1111/j.1365-2036.2011.04861.x. Epub 2011 Oct 9.
Poynard T, Bedossa P, Opolon P. Natural history of liver fibrosis progression in patients with chronic hepatitis C. The OBSVIRC, METAVIR, CLINIVIR, and DOSVIRC groups. Lancet. 1997 Mar 22;349(9055):825-32. doi: 10.1016/s0140-6736(96)07642-8.
Thein HH, Yi Q, Dore GJ, Krahn MD. Estimation of stage-specific fibrosis progression rates in chronic hepatitis C virus infection: a meta-analysis and meta-regression. Hepatology. 2008 Aug;48(2):418-31. doi: 10.1002/hep.22375.
Other Identifiers
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826229
Identifier Type: -
Identifier Source: org_study_id
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