Hepatitis DNCT02044055
Mother-to-child Hepatitis D Transmission
An observational study of Hepatitis D and Transmission, run by Hopital Lariboisière at 1 site in France.
Trial summary
HBV can be transmitted from mother-to-child, with a risk increasing according to maternal HBV DNA during pregnancy. HDV is a defective virus using HBs Ag for its own replication. Nucleosides analogues have only a minor impact on quantitative HBs Ag level. Read more about this study
- Who is it for?
- Ages 9 months to 15 years
- Conditions the study is for
- Hepatitis D, Transmission
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Apr 2017
- 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: All children born in the Maternity Department, Lariboisiere Hospital, from HBV-HDV co-infected women
Who may be able to join
- children born in the Maternity Department, Lariboisiere Hospital,
- from HBV-HDV co-infected women
- with a positive HDV RNA during pregnancy in the pregnant woman
Who cannot join
- negative HDV RNA during pregnancy in the pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hepatitis D Virus (HDV) Mother-To-Child Transmission (MTCT) From Hepatitis B Virus (HBV)-Hepatitis D Virus (HDV) Co-infected Pregnant Women: a Retrospective Study.
HBV can be transmitted from mother-to-child, with a risk increasing according to maternal HBV DNA during pregnancy. HDV is a defective virus using HBs Ag for its own replication. Nucleosides analogues have only a minor impact on quantitative HBs Ag level. Data about vertical HDV transmission are old, justifying a new study.
Read the detailed description
Hepatitis B Virus (HBV) can be transmitted from mother-to-child, with a risk increasing according to maternal HBV DNA viral load during the last trimester of pregnancy. Nucleosides analogues, lamivudine, telbivudine, or nucleotides analogues, tenofovir DF decrease HBV mother-to-child transmission risk, and are recommended in Guidelines (EASL 2012) for pregnant women with HBV DNA above 1,000 000 I.U/mL. HDV is a defective virus using HBs Ag for its own replication. HDV-HBV co-infection is a re-emerging infectious disease in western countries, due to immigration of people coming from endemic areas. Nucleosides analogues have only a minor impact on quantitative HBs Ag level (Boyd A et al. AIDS Research and Human Retroviruses 2013). Data about vertical HDV transmission are old (Rizzetto, et al. J Med Virol 1982), before a large use of nucleosides/nucleotides analogues in HBV infected pregnant women, justifying a new study.
- Conditions
- Hepatitis D, Transmission
- Medical subject headings
- Hepatitis D
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 |
|---|---|---|
| Children born to HBV-HDV women | Children born to HBV-HDV co-infected women will be checked for: * HDV antibodies * if positive, HDV RNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatitis D antibodies (Ab) in children
Antibodies (Ab) against Hepatitis D Virus (HDV)
Measured: up to 10 years (expected average: 5 years)
Secondary outcomes (1)
HDV RNA in children with positive HDV 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 completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis DStudies 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Lariboisière
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Célia Lloret-Linares, MD PhD, Hopital Lariboisière
- Investigators
- Pierre O SELLIER, M.D., Ph.D, Principal investigator, Hopital Lariboisiere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044055
- Sponsor's protocol ID
- Liver004
- Status last verified
- Apr 2017
- First submitted
- 18 Jan 2014
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sellier PO, Maylin S, Brichler S, Bercot B, Lopes A, Chopin D, Pogliaghi M, Munier AL, Delcey V, Simoneau G, Evans J, Gordien E, Simon F, Bergmann JF. Hepatitis B Virus-Hepatitis D Virus mother-to-child co-transmission: A retrospective study in a developed country. Liver Int. 2018 Apr;38(4):611-618. doi: 10.1111/liv.13556. Epub 2017 Sep 12.
PubMed 28834623
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis D Virus (HDV) Mother-To-Child Transmission (MTCT) From Hepatitis B Virus (HBV)-Hepatitis D Virus (HDV) Co-infected Pregnant Women: a Retrospective Study.
- ClinicalTrials.gov ID
- NCT02044055
- Acronym / sponsor ID
- Liver004
- Conditions
- Hepatitis D, Transmission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hopital LariboisièreUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- 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.
HBV can be transmitted from mother-to-child, with a risk increasing according to maternal HBV DNA during pregnancy. HDV is a defective virus using HBs Ag for its own replication. Nucleosides analogues have only a minor impact on quantitative HBs Ag level. Data about vertical HDV transmission are old, justifying a new study.
Detailed description
Hepatitis B Virus (HBV) can be transmitted from mother-to-child, with a risk increasing according to maternal HBV DNA viral load during the last trimester of pregnancy. Nucleosides analogues, lamivudine, telbivudine, or nucleotides analogues, tenofovir DF decrease HBV mother-to-child transmission risk, and are recommended in Guidelines (EASL 2012) for pregnant women with HBV DNA above 1,000 000 I.U/mL. HDV is a defective virus using HBs Ag for its own replication. HDV-HBV co-infection is a re-emerging infectious disease in western countries, due to immigration of people coming from endemic areas. Nucleosides analogues have only a minor impact on quantitative HBs Ag level (Boyd A et al. AIDS Research and Human Retroviruses 2013). Data about vertical HDV transmission are old (Rizzetto, et al. J Med Virol 1982), before a large use of nucleosides/nucleotides analogues in HBV infected pregnant women, justifying a new study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children born to HBV-HDV women | – | –Children born to HBV-HDV co-infected women will be checked for: * HDV antibodies * if positive, HDV RNA |
Who may qualify
- Ages
- 9 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children born in the Maternity Department, Lariboisiere Hospital, from HBV-HDV co-infected women
Key inclusion criteria (3 listed)
- children born in the Maternity Department, Lariboisiere Hospital,
- from HBV-HDV co-infected women
- with a positive HDV RNA during pregnancy in the pregnant woman
Key exclusion criteria (1 listed)
- negative HDV RNA during pregnancy in the pregnant woman
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
Hepatitis D antibodies (Ab) in children
Time frame: up to 10 years (expected average: 5 years)
Antibodies (Ab) against Hepatitis D Virus (HDV)
1 secondary outcome
HDV RNA in children with positive HDV Ab
Time frame: up to 10 years (expected average: 5 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Derived from this study: PubMed 28834623Sellier PO, Maylin S, Brichler S, Bercot B, Lopes A, Chopin D, Pogliaghi M, Munier AL, Delcey V, Simoneau G, Evans J, Gordien E, Simon F, Bergmann JF. Hepatitis B Virus-Hepatitis D Virus mother-to-child co-transmission: A retrospective study in a developed country. Liver Int. 2018 Apr;38(4):611-618. doi: 10.1111/liv.13556. Epub 2017 Sep 12.
- Individual participant dataSharing planned: No
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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 D 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 1 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: finished, as of the sponsor's last update on 27 Apr 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatitis D antibodies (Ab) in children (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?
On the ClinicalTrials.gov record for NCT02044055, which also lists 1 linked publication.
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 27 Apr 2017.