Vertical Transmission of Hepatitis C Virus

Sponsor

Hopital Lariboisière (Other)

Overall Status

Unknown status

CT.gov ID

NCT02044042

Collaborator

(none)

120

Enrollment

Location

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Transmission

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Oct 1, 2014

Anticipated Primary Completion Date :

Jul 1, 2016

Anticipated Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
HCV pregnant women HCV chronically infected pregnant women, with a positive HCV RNA during pregnancy

Outcome Measures

Primary Outcome Measures

HCV status in children born from chronically HCV infected pregnant women [up to 10 years (expected average: 5 years)]

Secondary Outcome Measures

HCV RNA in children with positive HCV antibodies (Ab) [up to 10 years (expected average: 5 years)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Months to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Lariboisiere	Paris		France	75475

Sponsors and Collaborators

Hopital Lariboisière

Investigators

Principal Investigator: Pierre O SELLIER, M.D., Ph.D, Hopital Lariboisiere

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stephane Mouly, MD PhD, Professor at University Paris VII Denis Diderot, physician, Hopital Lariboisière

ClinicalTrials.gov Identifier:

NCT02044042

Other Study ID Numbers:

Liver005

First Posted:

Jan 23, 2014

Last Update Posted:

Oct 2, 2015

Last Verified:

Sep 1, 2015

Additional relevant MeSH terms:

Hepatitis A

Hepatitis C

Hepatitis

Study Results

No Results Posted as of Oct 2, 2015