Chronic Hepatitis B, GestationPhase 4NCT00939068
Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission
A Phase 4 study testing Telbivudine and engineered HB vaccine in people with Chronic Hepatitis B, Gestation, run by Southeast University, China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Telbivudine in 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, Gestation
- What is being tested?
- Telbivudine and engineered HB vaccine
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Nov 2010
- 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
- 20-40 years old pregnant woman with gestational age of 20-32 week;
- positive serum HBsAg;
- HBV DNA≥1.0x106 copies/ml;
Who cannot join
- with previous antiviral treatment;
- with clinical sign of threatened miscarriage or related treatment in early pregnancy;
- positive serum HAV, HCV, HDV and HEV tests;
- fetus deformity by 3-D ultrasound examination;
- on other dugs, such as immune modulators, cytotoxic drugs or steroids;
- husbands are infected with HBV.
About this study
Official title: A Study of Efficacy and Safety of Telbivudine in Pregnancy for the Prevention of Perinatal Transmission of Hepatitis B Virus Infection
The purpose of this study is to evaluate the efficacy and safety of Telbivudine in pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.
Read the detailed description
In the present study, we evaluated the effect of telbivudine given during the second and third trimesters of pregnancy to highly viremic, HBV DNA-positive mothers on maternal HBV DNA and HBeAg levels prior to delivery and the rate of vertical transmission of HBV to infants who received passive-active immunoprophylaxis. Additionally, we investigated the timing of the administration of telbivudine on reducing the risk of perinatal transmission and the safety of telbivudine during pregnancy.
- Conditions
- Chronic Hepatitis B, Gestation
- Being tested
- Telbivudine, engineered HB vaccine
- Keywords
- Chronic hepatitis B, Telbivudine, Intrauterine transmission
- 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 telbivudine treatment
Subjects start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continued to one month after delivery.
engineered HB vaccineBiological
Also called control group
All the newborns in control group are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20 ug respectively at age of 0, 1 and 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Telbivudine | Experimental | Drug administration and follow up: the subjects in Telbivudine group start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continue to one month after delivery.And their newborns are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20ug respectively at age of 0, 1 and 6 months. Receives: Drug: Telbivudine |
| Control | Other | The pregnant subjects in Control group are intervented with no drugs, but their newborns are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20ug respectively at age of 0, 1 and 6 months. Receives: Biological: engineered HB vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the intrauterine transmission rate;vertical transmission rate (intrauterine and delivery)
Measured: 1 month post partum
Secondary outcomes (2)
liver function normalization rate; HBV DNA and HBeAg reduction and negative conversion rate;
Measured: 1 month post partum
drug adverse reaction in pregnant women; complications during pregnancy and delivery, gestational age at delivery, the method of delivery, peripartum hemorrhage, the newborn growth and development milestones, Apgar score, newborn deformity prevalence
Measured: .1 year after childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startFeb 2008
- Primary completionJul 2010 (estimated)
- Study completionNov 2010 (estimated)
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 B, GestationStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Investigators
- Wei Zhao, P.H.D, Study chair, the Second Affiliated Hospital of Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939068
- Sponsor's protocol ID
- H200804
- Status last verified
- Oct 2009
- First submitted
- 13 Jul 2009
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Han GR, Jiang HX, Wang CM, Ding Y, Wang GJ, Yue X, Zhou L, Zhao W. Long-term safety and efficacy of telbivudine in infants born to mothers treated during the second or third trimesters of pregnancy. J Viral Hepat. 2017 Jun;24(6):514-521. doi: 10.1111/jvh.12670. Epub 2017 Feb 14.
PubMed 28039902
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Efficacy and Safety of Telbivudine in Pregnancy for the Prevention of Perinatal Transmission of Hepatitis B Virus Infection
- ClinicalTrials.gov ID
- NCT00939068
- Acronym / sponsor ID
- H200804
- Conditions
- Chronic Hepatitis B, Gestation
- Keywords
- Chronic hepatitis B, Telbivudine, Intrauterine transmission
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 14 Jul 2009 (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 in pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.
Detailed description
In the present study, we evaluated the effect of telbivudine given during the second and third trimesters of pregnancy to highly viremic, HBV DNA-positive mothers on maternal HBV DNA and HBeAg levels prior to delivery and the rate of vertical transmission of HBV to infants who received passive-active immunoprophylaxis. Additionally, we investigated the timing of the administration of telbivudine on reducing the risk of perinatal transmission and the safety of telbivudine during pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telbivudine | Experimental | Drug: TelbivudineDrug administration and follow up: the subjects in Telbivudine group start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continue to one month after delivery.And their newborns are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20ug respectively at age of 0, 1 and 6 months. |
| Control | Other | Biological: engineered HB vaccineThe pregnant subjects in Control group are intervented with no drugs, but their newborns are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20ug respectively at age of 0, 1 and 6 months. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20-40 years old pregnant woman with gestational age of 20-32 week;
- positive serum HBsAg;
- HBV DNA≥1.0x106 copies/ml;
Key exclusion criteria (6 listed)
- with previous antiviral treatment;
- with clinical sign of threatened miscarriage or related treatment in early pregnancy;
- positive serum HAV, HCV, HDV and HEV tests;
- fetus deformity by 3-D ultrasound examination;
- on other dugs, such as immune modulators, cytotoxic drugs or steroids;
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: telbivudine treatmentSubjects start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continued to one month after delivery. | Drug | Telbivudine |
| engineered HB vaccineAlso: control groupAll the newborns in control group are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20 ug respectively at age of 0, 1 and 6 months. | Biological | Control |
Primary outcome
the intrauterine transmission rate;vertical transmission rate (intrauterine and delivery)
Time frame: 1 month post partum
2 secondary outcomes
liver function normalization rate; HBV DNA and HBeAg reduction and negative conversion rate;
Time frame: 1 month post partum
drug adverse reaction in pregnant women; complications during pregnancy and delivery, gestational age at delivery, the method of delivery, peripartum hemorrhage, the newborn growth and development milestones, Apgar score, newborn deformity prevalence
Time frame: .1 year after childbirth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2009.
- Derived from this study: PubMed 28039902Han GR, Jiang HX, Wang CM, Ding Y, Wang GJ, Yue X, Zhou L, Zhao W. Long-term safety and efficacy of telbivudine in infants born to mothers treated during the second or third trimesters of pregnancy. J Viral Hepat. 2017 Jun;24(6):514-521. doi: 10.1111/jvh.12670. Epub 2017 Feb 14.
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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.
Wei Zhao, P.H.D study chair
the Second Affiliated Hospital of Southeast University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telbivudine and engineered HB vaccine in people with Chronic Hepatitis B, Gestation, run by Southeast University, 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 3 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: status not confirmed, as of the sponsor's last update on 14 Oct 2009. 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?
Results are not available in the source record.
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 intrauterine transmission rate;vertical transmission rate (intrauterine and delivery) (time frame: 1 month post partum). 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 NCT00939068, 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 14 Oct 2009.