Chronic Hepatitis BPhase 4NCT01743079
Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B
A Phase 4 study testing Telbivudine and Lamivudine in people with Chronic Hepatitis B and Late Pregnancy, run by Beijing YouAn Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of telbivudine and lamivudine use during late pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Chronic Hepatitis B, Late Pregnancy, Transmission
- What is being tested?
- Telbivudine and Lamivudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- Jan 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 20-40 years old
- HBsAg, HBeAg positive and HBV DNA >6 log10 copies/ml
- Gestational age: 26-28 weeks with normal fetus
- Willing to consent for the study
Who cannot join
- Elevated ALT
- Antiviral treatment experience patients
- Co-infection with HAV, HCV,HDV, HIV
- Concurrent treatment with immune modulators, cytotoxic drugs, or steroids
- Clinical signs of threatened miscarriage in early pregnancy
- Clinical evidence of cirrhosis and/or hepatocellular carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Telbivudine and Lamivudine Use in Highly Viremic Mothers to Prevent Hepatitis B Transmission
The purpose of this study is to evaluate the efficacy and safety of telbivudine and lamivudine use during late pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.
Read the detailed description
This study enrolls HBV mono-infected pregnant women cohorts managed in outpatient clinics/delivery unit at YouAn Hospital in Beijing. Subjects are prospectively followed from gestation week 26 to postpartum week 52. Treatment naïve mothers with HBV DNA > 6 log10 c/mL and normal ALT are eligible. Mothers with abnormal fetus, cirrhosis or evidence of hepatocellular carcinoma (HCC) are excluded. At gestation week 28, mothers will receive telbivudine (LdT) 600 mg per day or lamivudine (Lam) 100 mg per day until postpartum 4 or no treatment as per their preference. All infants will receive standard immunoprophylaxis. Data is collected from patient records using data extraction forms. Primary endpoints are vertical transmission rates at infants' age of 52 week and the safety of telbivudine or lamivudine use.
- Conditions
- Chronic Hepatitis B, Late Pregnancy, Transmission, Complication
- Being tested
- Telbivudine, Lamivudine
- Keywords
- Telbivudine, Lamivudine, safety, efficacy, pregnancy
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelbivudineDrug
Also called LdT
LdT 600mg QD
LamivudineDrug
Also called LAM
LAM 100mg QD
| Study group | Role | What they receive |
|---|---|---|
| Telbivudine | Experimental | Mother receives telbivudine 600mg per day. Infant receives standard immunoprophylaxis Receives: Drug: Telbivudine |
| Lamivudine | Experimental | Mother receives lamivudine 100mg per day. Infant receives standard immunoprophylaxis. Receives: Drug: Lamivudine |
| No antiviral treatment | No intervention | Mother receives no antiviral treatment. Infant receives standard immunoprophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety on fetal exposure of telbivudine and lamivudine and vertical transmission rate from mother to child
Measured: From gestation week 26 to postpartum week 52
Secondary outcomes (1)
percentage of mothers with serum HBV DNA level reduction, ALT within normal range and HBeAg and/or HBsAg negativity with or without seroconversion
Measured: From gestation week 26 to pastpartume week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startJan 2009
- Primary completionJul 2013
- Study completionJul 2013
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 Chronic Hepatitis BStudies 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
- Beijing YouAn Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- New Discovery LLC
- Responsible party
- Principal investigator, Hua Zhang, Beijing YouAn Hospital
- Investigators
- Calvin Pan, MD, Study director, Division of Liver Diseases, Mount Sinai School of Medicine, Flushing, NYHua Zhang, MD, Principal investigator, Beijing YouAn Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743079
- Sponsor's protocol ID
- 20080810
- Status last verified
- Jul 2013
- First submitted
- 3 Dec 2012
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang H, Pan CQ, Pang Q, Tian R, Yan M, Liu X. Telbivudine or lamivudine use in late pregnancy safely reduces perinatal transmission of hepatitis B virus in real-life practice. Hepatology. 2014 Aug;60(2):468-76. doi: 10.1002/hep.27034. Epub 2014 Jan 27.
PubMed 25187919
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
- The Efficacy and Safety of Telbivudine and Lamivudine Use in Highly Viremic Mothers to Prevent Hepatitis B Transmission
- ClinicalTrials.gov ID
- NCT01743079
- Acronym / sponsor ID
- 20080810
- Conditions
- Chronic Hepatitis B, Late Pregnancy, Transmission, Complication
- Keywords
- Telbivudine, Lamivudine, safety, efficacy, pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Beijing YouAn HospitalUniversity, hospital or other
- Collaborators
- New Discovery LLC
- Study start
- Jan 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Dec 2012 (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.
The purpose of this study is to evaluate the efficacy and safety of telbivudine and lamivudine use during late pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.
Detailed description
This study enrolls HBV mono-infected pregnant women cohorts managed in outpatient clinics/delivery unit at YouAn Hospital in Beijing. Subjects are prospectively followed from gestation week 26 to postpartum week 52. Treatment naïve mothers with HBV DNA > 6 log10 c/mL and normal ALT are eligible. Mothers with abnormal fetus, cirrhosis or evidence of hepatocellular carcinoma (HCC) are excluded. At gestation week 28, mothers will receive telbivudine (LdT) 600 mg per day or lamivudine (Lam) 100 mg per day until postpartum 4 or no treatment as per their preference. All infants will receive standard immunoprophylaxis. Data is collected from patient records using data extraction forms. Primary endpoints are vertical transmission rates at infants' age of 52 week and the safety of telbivudine or lamivudine use.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telbivudine | Experimental | Drug: TelbivudineMother receives telbivudine 600mg per day. Infant receives standard immunoprophylaxis |
| Lamivudine | Experimental | Drug: LamivudineMother receives lamivudine 100mg per day. Infant receives standard immunoprophylaxis. |
| No antiviral treatment | No intervention | –Mother receives no antiviral treatment. Infant receives standard immunoprophylaxis |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 20-40 years old
- HBsAg, HBeAg positive and HBV DNA >6 log10 copies/ml
- Gestational age: 26-28 weeks with normal fetus
- Willing to consent for the study
Key exclusion criteria (6 listed)
- Elevated ALT
- Antiviral treatment experience patients
- Co-infection with HAV, HCV,HDV, HIV
- Concurrent treatment with immune modulators, cytotoxic drugs, or steroids
- Clinical signs of threatened miscarriage in early pregnancy
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 |
|---|---|---|
| TelbivudineAlso: LdTLdT 600mg QD | Drug | Telbivudine |
| LamivudineAlso: LAMLAM 100mg QD | Drug | Lamivudine |
Primary outcome
Safety on fetal exposure of telbivudine and lamivudine and vertical transmission rate from mother to child
Time frame: From gestation week 26 to postpartum week 52
1 secondary outcome
percentage of mothers with serum HBV DNA level reduction, ALT within normal range and HBeAg and/or HBsAg negativity with or without seroconversion
Time frame: From gestation week 26 to pastpartume week 52
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.
- Derived from this study: PubMed 25187919Zhang H, Pan CQ, Pang Q, Tian R, Yan M, Liu X. Telbivudine or lamivudine use in late pregnancy safely reduces perinatal transmission of hepatitis B virus in real-life practice. Hepatology. 2014 Aug;60(2):468-76. doi: 10.1002/hep.27034. Epub 2014 Jan 27.
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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.
Calvin Pan, MD study director
Division of Liver Diseases, Mount Sinai School of Medicine, Flushing, NY
Hua Zhang, MD principal investigator
Beijing YouAn Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telbivudine and Lamivudine in people with Chronic Hepatitis B and Late Pregnancy, run by Beijing YouAn Hospital at 1 site in China.
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 4 inclusion and 6 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.
Where is the study taking place?
The record lists 1 site in China. 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.
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?
Safety on fetal exposure of telbivudine and lamivudine and vertical transmission rate from mother to child (time frame: From gestation week 26 to postpartum week 52). 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 NCT01743079, 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 30 Jul 2013.