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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03038763
• Other study ID #: 826229
• Status: Completed
• Start date: May 11, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Gilead Sciences

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2005 Oct 28. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Voelker R. Birth cohort screening may help find hepatitis C cases. JAMA. 2012 Mar 28;307(12):1242. doi: 10.1001/jama.2012.337. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV prevalence	Prevalence of HCV in adult children of female baby boomers who have or have had HCV	Within 1 week of labwork at first study visit
Secondary	Liver fibrosis	Level of liver fibrosis (detected through fibrosure test) found in adult children diagnosed as HCV-positive	Within 2 weeks of diagnosis of HCV
Secondary	HCV genotype	HCV genotype for adult children diagnosed as HCV-positive	Within 6 weeks of diagnosis of HCV