Hepatitis B, ChronicNCT02719808
Study of Antiretroviral Therapy to Prevent HBV Intrauterine Infection
An observational study of Hepatitis B, Chronic, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
500 pregnant patients with HBeAg-positive and HBV-DNA≥ 106copies /ml who will do their pregnant check in the First Affiliated Hospital of Xi'an Jiaotong University will be enrolled into the study. There will be five groups to be observed. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Tenofovir1, Tenofovir2 and Tenofovir3
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Dec 2022
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: pregnant women with HBeAg-positive and HBV-DNA>106copies/ml from the out-patient department of First Affiliated Hospital of Xi'an Jiaotong University
Who may be able to join
- pregnancy patients with HBeAg-positive and HBV-DNA≥ 106copies /ml
Who cannot join
- pregnancy patients with HBeAg-negative or HBV-DNA<106copies /ml
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Guiqin Bai, M.D.;Ph.D., 86-18991232517, baigq@126.com
About this study
Official title: A Cohort Study of Tenofovir on Blocking HBV Intrauterine Infection
500 pregnant patients with HBeAg-positive and HBV-DNA≥ 106copies /ml who will do their pregnant check in the First Affiliated Hospital of Xi'an Jiaotong University will be enrolled into the study. There will be five groups to be observed. Four groups are taking tenofovir to prevent intrauterine infection during pregnancy. One group is not taking any anti-HBV virus treatments.The clinical value and effectiveness of tenofovir on blocking HBV intrauterine infection will be evaluated; The HBV-DNA infection status of placenta tissue will be checked by quantitative Polymerase Chain Reaction (PCR) to assess the changes of HBV-DNA of placenta after treating with tenofovir and explore the mechanism of tenofovir blocking HBV intrauterine infection. The safety of Tenofovir will be assessed as well.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Tenofovir1, Tenofovir2, Tenofovir3, Tenofovir4
- Keywords
- Vertical infection transmission, Tenofovir
- 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.
Tenofovir1Drug
receive tenofovir （300mg/d）from （28±2）weeks of pregnancy to one month after delivery, it is the observational exposure.
Tenofovir2Drug
receive tenofovir （300mg/d）from（28±2）weeks of pregnancy to one month after delivery, it is the observational exposure.
Tenofovir3Drug
receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one month after delivery, it is the observational exposure.
Tenofovir4Drug
receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one week after delivery, it is the observational exposure.
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir1 | 100 patients receive tenofovir （300mg/d）from (28±2） weeks of pregnancy to one week after delivery. Receives: Drug: Tenofovir1 | |
| Tenofovir2 | 100 patients receive tenofovir （300mg/d）from (28±2） weeks of pregnancy to one month after delivery. Receives: Drug: Tenofovir2 | |
| Tenofovir3 | 100 patients receive tenofovir （300mg/d）from （24±2）weeks of pregnancy to one week after delivery. Receives: Drug: Tenofovir3 | |
| Tenofovir4 | 100 patients receive tenofovir （300mg/d）from （24±2）weeks of pregnancy to one month after delivery. Receives: Drug: Tenofovir4 | |
| Group without any treatment | 100 patients don't receive any blockade therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
deoxyribonucleic acid of Hepatitis B Virus (HBV-DNA) in serum
Check HBV-DNA in serum by ELISA in pregnant women. The measure unit is copies/mL
Measured: up to 1 year
deoxyribonucleic acid of Hepatitis B Virus (HBV-DNA) in serum
Check HBV-DNA in serum by quantitative PCR in pregnant women. The measure unit is copies/mL
Measured: up to 1 year
Secondary outcomes (8)
the concentration of Interleukin 2 (IL-2)
the concentration of Interleukin 2 (IL-2)in serum of pregnant women, U/mL
Measured: up to 1 year
interferon-γ (IFN-γ)
the concentration of interferon-γ (IFN-γ) in serum of pregnant women,U/mL
Measured: up to 1 year
Interleukin 4 (IL-4)
the concentration of Interleukin 4 (IL-4)in serum of pregnant women, U/mL
Measured: up to 1 year
Interleukin 6 (IL-6)
the concentration of Interleukin 6 (IL-6)in serum of pregnant women,U/mL
Measured: up to 1 year
T cell ratio
T cell ratio in serum is measured by follow cytometry in pregnant women
Measured: up to 1 year
HBV-DNA of babies
Check HBV-DNA by ELISA and quantitative PCR. The measure unit is copies/mL. All babies who used tenofovir will be tested when he is 7-month-old, in order to make sure whether they have infection during pregnant period.
Measured: when the baby is 7-month-old
hepatitis B e-antigen (HBeAg)
check HBeAg in serum of pregnant women.the measure unit is PEIU/mL
Measured: up to 1 year
HBV-DNA in placenta tissue
Check HBV-DNA of placenta tissue by quantitative PCR. The measure unit is copies/mL.
Measured: the date of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startMar 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (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 Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guiqin Bai, M.D.;Ph.D., Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719808
- Sponsor's protocol ID
- XJTU1AHCR2014-018
- Status last verified
- Nov 2020
- First submitted
- 6 Mar 2016
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gao F, Zhang WT, Lin YY, Wang WM, Xu N, Bai GQ. Early Start Of Tenofovir Treatment Achieves Better Viral Suppression In Pregnant Women With A High HBV Viral Load: A Real-World Prospective Study. Infect Drug Resist. 2019 Nov 7;12:3475-3484. doi: 10.2147/IDR.S228982. eCollection 2019.
PubMed 31807036
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of Tenofovir on Blocking HBV Intrauterine Infection
- ClinicalTrials.gov ID
- NCT02719808
- Acronym / sponsor ID
- XJTU1AHCR2014-018
- Conditions
- Hepatitis B, Chronic
- Keywords
- Vertical infection transmission, Tenofovir
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 25 Mar 2016 (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.
500 pregnant patients with HBeAg-positive and HBV-DNA≥ 106copies /ml who will do their pregnant check in the First Affiliated Hospital of Xi'an Jiaotong University will be enrolled into the study. There will be five groups to be observed. Four groups are taking tenofovir to prevent intrauterine infection during pregnancy. One group is not taking any anti-HBV virus treatments.The clinical value and effectiveness of tenofovir on blocking HBV intrauterine infection will be evaluated; The HBV-DNA infection status of placenta tissue will be checked by quantitative Polymerase Chain Reaction (PCR) to assess the changes of HBV-DNA of placenta after treating with tenofovir and explore the mechanism of tenofovir blocking HBV intrauterine infection. The safety of Tenofovir will be assessed as well.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Tenofovir1 | – | Drug: Tenofovir1100 patients receive tenofovir （300mg/d）from (28±2） weeks of pregnancy to one week after delivery. |
| Tenofovir2 | – | Drug: Tenofovir2100 patients receive tenofovir （300mg/d）from (28±2） weeks of pregnancy to one month after delivery. |
| Tenofovir3 | – | Drug: Tenofovir3100 patients receive tenofovir （300mg/d）from （24±2）weeks of pregnancy to one week after delivery. |
| Tenofovir4 | – | Drug: Tenofovir4100 patients receive tenofovir （300mg/d）from （24±2）weeks of pregnancy to one month after delivery. |
| Group without any treatment | – | –100 patients don't receive any blockade therapies |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pregnant women with HBeAg-positive and HBV-DNA>106copies/ml from the out-patient department of First Affiliated Hospital of Xi'an Jiaotong University
Key inclusion criteria (1 listed)
- pregnancy patients with HBeAg-positive and HBV-DNA≥ 106copies /ml
Key exclusion criteria (1 listed)
- pregnancy patients with HBeAg-negative or HBV-DNA<106copies /ml
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 |
|---|---|---|
| Tenofovir1receive tenofovir （300mg/d）from （28±2）weeks of pregnancy to one month after delivery, it is the observational exposure. | Drug | Tenofovir1 |
| Tenofovir2receive tenofovir （300mg/d）from（28±2）weeks of pregnancy to one month after delivery, it is the observational exposure. | Drug | Tenofovir2 |
| Tenofovir3receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one month after delivery, it is the observational exposure. | Drug | Tenofovir3 |
| Tenofovir4receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one week after delivery, it is the observational exposure. | Drug | Tenofovir4 |
Primary outcome
deoxyribonucleic acid of Hepatitis B Virus (HBV-DNA) in serum
Time frame: up to 1 year
Check HBV-DNA in serum by ELISA in pregnant women. The measure unit is copies/mL
deoxyribonucleic acid of Hepatitis B Virus (HBV-DNA) in serum
Time frame: up to 1 year
Check HBV-DNA in serum by quantitative PCR in pregnant women. The measure unit is copies/mL
8 secondary outcomes
the concentration of Interleukin 2 (IL-2)
Time frame: up to 1 year
interferon-γ (IFN-γ)
Time frame: up to 1 year
Interleukin 4 (IL-4)
Time frame: up to 1 year
Interleukin 6 (IL-6)
Time frame: up to 1 year
T cell ratio
Time frame: up to 1 year
HBV-DNA of babies
Time frame: when the baby is 7-month-old
hepatitis B e-antigen (HBeAg)
Time frame: up to 1 year
HBV-DNA in placenta tissue
Time frame: the date of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Derived from this study: PubMed 31807036Gao F, Zhang WT, Lin YY, Wang WM, Xu N, Bai GQ. Early Start Of Tenofovir Treatment Achieves Better Viral Suppression In Pregnant Women With A High HBV Viral Load: A Real-World Prospective Study. Infect Drug Resist. 2019 Nov 7;12:3475-3484. doi: 10.2147/IDR.S228982. eCollection 2019.
- 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.
Guiqin Bai, M.D.;Ph.D. principal investigator
First Affiliated Hospital Xi'an Jiaotong University
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 B, Chronic, run by First Affiliated Hospital Xi'an Jiaotong University 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 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: status not confirmed, as of the sponsor's last update on 18 Nov 2020. 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.
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 Guiqin Bai, M.D.;Ph.D. (86-18991232517, baigq@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
deoxyribonucleic acid of Hepatitis B Virus (HBV-DNA) in serum (time frame: up to 1 year). 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?
On the ClinicalTrials.gov record for NCT02719808, 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 18 Nov 2020.