Vertical Transmission of Hepatitis C Virus

Hepatitis C Clinical Trial

Official title:

Mother-To-Child Transmission (MTCT) of Hepatitis C Virus and Spontaneous Viral Clearance in Infected Children: a Retrospective Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02044042
• Other study ID #: Liver005
• Status: Recruiting
• Phase: N/A
• First received: January 19, 2014
• Last updated: September 30, 2015
• Start date: October 2014
• Est. completion date: July 2016

Study information

• Verified date: September 2015
• Source: Hopital Lariboisière
• Contact: Pierre O SELLIER, M.D., Ph.D
• Phone: 00 33 149956339
• Email: pierre.sellier[@]lrb.aphp.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial Summary

Vertical HCV Transmission has been extensively studied, with a risk around 5% (range: 3 to 10%). Spontaneous viral clearance in infected children during childhood can occur, but data about this phenomenon are scarse, justifying the study.

Description:

Hepatitis C Virus (HCV) Mother-To-Child Transmission (MTCT) has been extensively studied, with a risk around 5% (range: 3 to 10%) from chronically infected pregnant women with a positive HCV RNA during pregnancy. Risk factors include: HCV RNA load level, HIV-HCV co-infection, duration of labour, HCV genotype, child gender, and invasive procedures either during pregnancy or at birth. Hepatitis C Virus (HCV) Mother-To-Child Transmission (MTCT) mainly occurs during the last trimester of pregnancy or at birth or around the birth (El-Shabrawi et al., World Journal of Gastroenterology 2013). Currently, using caesarian section to reduce the risk of Hepatitis C Virus (HCV) Mother-To-Child Transmission (MTCT) is still debated and not recommended in International Guidelines (EASL 2012). Spontaneous viral clearance in infected children during childhood seems to occur in 20% of cases, with predisposing genetic factors (Ruiz-Extremera A et al. Hepatology 2011 ; 53 : 1830-1838) but data about this phenomenon are scarse (Rerksuppaphol S et al. J Gastroenterol Hepatol 2004), justifying the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Months to 15 Years

Eligibility

Inclusion Criteria:

• HCV chronically infected pregnant women

• with a positive HCV RNA

• who gave birth in the Maternity Department, Lariboisiere Hospital, Paris, France

Exclusion Criteria:

• negative HCV RNA during pregnancy

• acute HCV infection during pregnancy (previous negative HCV test during pregnancy)

• MTCT not to be tested (early child death for instance)

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Transmission

Locations

Country	Name	City	State
France	Hopital Lariboisiere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Lariboisière

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV status in children born from chronically HCV infected pregnant women		up to 10 years (expected average: 5 years)	No
Secondary	HCV RNA in children with positive HCV antibodies (Ab)		up to 10 years (expected average: 5 years)	No