Hepatitis B InfectionPhase 4NCT01788371
Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus
A Phase 4 study testing Telbivudine and Lamivudine in people with Hepatitis B Infection and Chronic Infection, run by Hua Zhang.
Trial summary
To explore the antiviral effect of nucleoside analogue in late pregnancy and the safety of the antiviral drug to fetus.To establish the best therapy strategy to pregnant women with high level of HBV DNA. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Hepatitis B Infection, Chronic Infection, Viremia
- What is being tested?
- Telbivudine and Lamivudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Jul 2013
- Phase
- Phase 4
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- HBeAg+CHB pregnant woman gestational age 28 weeks HBV-DNA>log10 copies/ml
Who cannot join
- co-infection with hepatitis A,C,D,E or HIV evidence of hepatocellular carcinoma decompensated liver disease or significant co-morbidity concurrent treatment with immune-modulators,cytotoxic drugs,or steroids clinical signs of threatened miscarriage in early prenancy evidence of fetal deformity by ultrasound examination the biological father of the child had CHB
About this study
Official title: Nucleoside Analogue in Late Preganancy to Prevent Vertical Transmission of Hepatitis B Virus
To explore the antiviral effect of nucleoside analogue in late pregnancy and the safety of the antiviral drug to fetus.To establish the best therapy strategy to pregnant women with high level of HBV DNA.
Read the detailed description
Telbivudine and Lamivudine,a preganancy category B medication,reduces HBV DNA and normalizes serum ALT in chronic hepatitis B patients with few adverse effects.Two aspects on the drug use in pregnancy will be evaluated prospectively in this study.
- Conditions
- Hepatitis B Infection, Chronic Infection, Viremia
- Being tested
- Telbivudine, Lamivudine
- Medical subject headings
- Hepatitis B, Persistent Infection, Viremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelbivudineDrug
About 300 mothers with no treatment observedfrom 28 weeks of pregnancy to the week 4 of postpartun
LamivudineDrug
About 300 mothers treated with lamivudine or telbivudine from 28 weeks of pregancy to the week 4 of postpartum
| Study group | Role | What they receive |
|---|---|---|
| No antiviral arm | No intervention | provide standard of care to mothers and standard immunoprophylaxis to their infants |
| Lamivudine | Experimental | lamivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants Receives: Drug: Lamivudine |
| Telbivudine | Experimental | Telbivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants Receives: Drug: Telbivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The data on its tolerability and safety in HBeAg+ pregnant woman with HBV DNA>6log10 copies/Ml during late pregnancy and infants
Measured: perinatal to 28 weeks after infant delivery
Its efficacy in the reduction of HBV vertical transmission rate
Measured: perinatal to 28 weeks after infant delivery
Secondary outcomes (1)
Maternal DNA reduction,ALT normalization, and loss/seroconversion of HBeAg or HBsAg
Measured: perinatal to 28 weeks of postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startMar 2009
- Primary completionJul 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B InfectionStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hua Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor-investigator, Hua Zhang, Beijing YouAn Hospital
- Investigators
- Hua Zhang, MD, Principal investigator, Beijing YouAn Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788371
- Sponsor's protocol ID
- 2011.6
- Status last verified
- Jul 2013
- First submitted
- 7 Feb 2013
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nucleoside Analogue in Late Preganancy to Prevent Vertical Transmission of Hepatitis B Virus
- ClinicalTrials.gov ID
- NCT01788371
- Acronym / sponsor ID
- 2011.6
- Conditions
- Hepatitis B Infection, Chronic Infection, Viremia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Hua ZhangUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- Mar 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 11 Feb 2013 (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.
To explore the antiviral effect of nucleoside analogue in late pregnancy and the safety of the antiviral drug to fetus.To establish the best therapy strategy to pregnant women with high level of HBV DNA.
Detailed description
Telbivudine and Lamivudine,a preganancy category B medication,reduces HBV DNA and normalizes serum ALT in chronic hepatitis B patients with few adverse effects.Two aspects on the drug use in pregnancy will be evaluated prospectively in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No antiviral arm | No intervention | –provide standard of care to mothers and standard immunoprophylaxis to their infants |
| Lamivudine | Experimental | Drug: Lamivudinelamivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants |
| Telbivudine | Experimental | Drug: TelbivudineTelbivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- HBeAg+CHB pregnant woman gestational age 28 weeks HBV-DNA>log10 copies/ml
Key exclusion criteria (1 listed)
- co-infection with hepatitis A,C,D,E or HIV evidence of hepatocellular carcinoma decompensated liver disease or significant co-morbidity concurrent treatment with immune-modulators,cytotoxic drugs,or steroids clinical signs of threatened miscarriage in early prenancy evidence of fetal deformity by ultrasound examination the biological father of the child had CHB
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelbivudineAbout 300 mothers with no treatment observedfrom 28 weeks of pregnancy to the week 4 of postpartun | Drug | Telbivudine |
| LamivudineAbout 300 mothers treated with lamivudine or telbivudine from 28 weeks of pregancy to the week 4 of postpartum | Drug | Lamivudine |
Primary outcome
The data on its tolerability and safety in HBeAg+ pregnant woman with HBV DNA>6log10 copies/Ml during late pregnancy and infants
Time frame: perinatal to 28 weeks after infant delivery
Its efficacy in the reduction of HBV vertical transmission rate
Time frame: perinatal to 28 weeks after infant delivery
1 secondary outcome
Maternal DNA reduction,ALT normalization, and loss/seroconversion of HBeAg or HBsAg
Time frame: perinatal to 28 weeks of postpartum
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 30 Jul 2013.
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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.
Hua Zhang, MD principal investigator
Beijing YouAn Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telbivudine and Lamivudine in people with Hepatitis B Infection and Chronic Infection, run by Hua Zhang.
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 1 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 30 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The data on its tolerability and safety in HBeAg+ pregnant woman with HBV DNA>6log10 copies/Ml during late pregnancy and infants (time frame: perinatal to 28 weeks after infant delivery). The study lists 2 primary outcomes in all. 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 30 Jul 2013.