NCT02044042

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 2, 2015

Status Verified

September 1, 2015

Enrollment Period

1.8 years

First QC Date

January 19, 2014

Last Update Submit

September 30, 2015

Conditions

Hepatitis CTransmission

Outcome Measures

Primary Outcomes (1)

  • HCV status in children born from chronically HCV infected pregnant women

    up to 10 years (expected average: 5 years)

Secondary Outcomes (1)

  • HCV RNA in children with positive HCV antibodies (Ab)

    up to 10 years (expected average: 5 years)

Study Arms (1)

HCV pregnant women

HCV chronically infected pregnant women, with a positive HCV RNA during pregnancy

Eligibility Criteria

Age9 Months - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

HCV chronically infected pregnant women with a positive HCV RNA who gave birth in the Maternity Department, Lariboisiere Hospital, Paris, France

You may qualify if:

  • HCV chronically infected pregnant women
  • with a positive HCV RNA
  • who gave birth in the Maternity Department, Lariboisiere Hospital, Paris, France

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Lariboisiere

Paris, 75475, France

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Pierre O SELLIER, M.D., Ph.D

    Hopital Lariboisiere

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre O SELLIER, M.D., Ph.D

CONTACT

00 33 149956339pierre.sellier@lrb.aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor at University Paris VII Denis Diderot, physician

Study Record Dates

First Submitted

January 19, 2014

First Posted

January 23, 2014

Study Start

October 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 2, 2015

Record last verified: 2015-09

Locations

FR(1)