Hepatitis CNCT02044042
Vertical Transmission of Hepatitis C Virus
An observational study of Hepatitis C and Transmission, run by Hopital Lariboisière at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 9 months to 15 years
- Conditions the study is for
- Hepatitis C, Transmission
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: HCV chronically infected pregnant women with a positive HCV RNA who gave birth in the Maternity Department, Lariboisiere Hospital, Paris, France
Who may be able to join
- HCV chronically infected pregnant women
- with a positive HCV RNA
- who gave birth in the Maternity Department, Lariboisiere Hospital, Paris, France
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Lariboisiere
Paris, 75475
Pierre O SELLIER, M.D., Ph.D, 00 33 149956339, pierre.sellier@lrb.aphp.fr
About this study
Official title: Mother-To-Child Transmission (MTCT) of Hepatitis C Virus and Spontaneous Viral Clearance in Infected Children: a Retrospective Study.
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.
Read the 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.
- Conditions
- Hepatitis C, Transmission
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HCV pregnant women | HCV chronically infected pregnant women, with a positive HCV RNA during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV status in children born from chronically HCV infected pregnant women
Measured: up to 10 years (expected average: 5 years)
Secondary outcomes (1)
HCV RNA in children with positive HCV antibodies (Ab)
Measured: up to 10 years (expected average: 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Lariboisière
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephane Mouly, MD PhD, Hopital Lariboisière
- Investigators
- Pierre O SELLIER, M.D., Ph.D, Principal investigator, Hopital Lariboisiere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044042
- Sponsor's protocol ID
- Liver005
- Status last verified
- Sep 2015
- First submitted
- 19 Jan 2014
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mother-To-Child Transmission (MTCT) of Hepatitis C Virus and Spontaneous Viral Clearance in Infected Children: a Retrospective Study.
- ClinicalTrials.gov ID
- NCT02044042
- Acronym / sponsor ID
- Liver005
- Conditions
- Hepatitis C, Transmission
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hopital LariboisièreUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCV pregnant women | – | –HCV chronically infected pregnant women, with a positive HCV RNA during pregnancy |
Who may qualify
- Ages
- 9 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- HCV chronically infected pregnant women with a positive HCV RNA who gave birth in the Maternity Department, Lariboisiere Hospital, Paris, France
Key inclusion criteria (3 listed)
- HCV chronically infected pregnant women
- with a positive HCV RNA
- who gave birth in the Maternity Department, Lariboisiere Hospital, Paris, France
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HCV status in children born from chronically HCV infected pregnant women
Time frame: up to 10 years (expected average: 5 years)
1 secondary outcome
HCV RNA in children with positive HCV antibodies (Ab)
Time frame: up to 10 years (expected average: 5 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre O SELLIER, M.D., Ph.D principal investigator
Hopital Lariboisiere
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C and Transmission, run by Hopital Lariboisière at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre O SELLIER, M.D., Ph.D (00 33 149956339, pierre.sellier@lrb.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV status in children born from chronically HCV infected pregnant women (time frame: up to 10 years (expected average: 5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2015.