Hepatitis B, ChronicPMFPOEPMWCHINCT04805034
Predictive Model for Prognosis of Chronic HBV Infection Mothers
An observational study of Hepatitis B, Chronic, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Pregnancy is a complex and coordinated physiological process. Pregnancy and the postpartum period are associated with unique changes in the immune system that may impact the natural history of autoimmune diseases and immune-mediated infections. In the postpartum period. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Age, BMI,Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2021to 31 Jan 2024
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Mothers with chronic hepatitis B infection
Who may be able to join
- Age 20-45 years old
- Serum HBsAg positive> 6 months
- HBeAg positive at delivery
- Good compliance
Who cannot join
- Women who give birth to stillbirth due to various reasons
- Coinfection with HIV,HCV, syphilis or other sexually transmitted diseases
- Severe kidney, cardiovascular, lung, nervous system or immune system diseases
- Who are taking immunotherapy drugs or anti-tumor drugs
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
Tianyan Chen, 0086-18991232530, chentianyan@126.com
About this study
Official title: Predictive Model for Prognosis of E Antigen-positive Mothers With Chronic HBV Infection: A Multicenter Cohort Study
Pregnancy is a complex and coordinated physiological process. Pregnancy and the postpartum period are associated with unique changes in the immune system that may impact the natural history of autoimmune diseases and immune-mediated infections. In the postpartum period. ALT flares have been reported in 20%-60% of untreated women and were more likely to occur in hepatitis B e antigen (HBeAg)-positive patients. It has been postulated that postpartum ALT flares may arise to rapid immune restitution against hepatitis B virus (HBV) antigens in the liver, when may be a timing of antiviral treatment. A large number of previous studies have focused on studies on the interruption of mother-to-child transmission in women with chronic hepatitis B(CHB), but studies on the prognosis of mothers undergoing pregnancy and delivery are very limited. What are the factors that affect the clearance of HBeAg or HBsAg? What kind of antiviral treatment protocol should be adopted for mothers with CHB? It is not only a problem that needs to be solved urgently in clinical practice, but also can provide some clues for understanding the occurrence and development of HBV infection in women of childbearing age.
Overall, this study intends to carry out a multi-center two-way cohort study on E antigen-positive CHB women in 9 hospitals in Shaanxi Province. To observe the dynamic changes of virological parameters in these patients, figure out the factors of the serum HBsAg loss and HBeAg seroconversion, and establish relevant predictive models.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Age, BMI,Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level
- 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.
Age, BMI,Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT levelOther
Exposure factors: Age, BMI, Family history, Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level
| Study group | Role | What they receive |
|---|---|---|
| HBeAg positive/HBsAg positive | Not described Receives: Other: Age, BMI,Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level | |
| HBeAg seroconversion /HBsAg loss | Not described Receives: Other: Age, BMI,Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of HBeAg loss
Measured: Postpartum 96weeks
the rate of HBeAg seroconversion
Measured: Postpartum 96weeks
the rate of HBsAg loss
Measured: Postpartum 96weeks
Secondary outcomes (3)
the rate of undetectable HBV DNA
Measured: Postpartum 96weeks
the rate ALT normalization
Measured: Postpartum 96weeks
Dynamic changes of serum HBsAg, HBeAg, HBV DNA and HBV RNA titer
Measured: at delivery, 12 weeks, 24 weeks, 48 weeks, 72 weeks, 96 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start16 Apr 2021
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Shaanxi Provincial People's Hospital, Baoji Maternal and Child Health Hospital, Weinan Central Hospital, Ankang Central Hospital, Hanzhong Central Hospital, Yan'an University Affiliated Hospital
- Responsible party
- Sponsor
- Investigators
- Tianyan Chen, phD, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805034
- Sponsor's protocol ID
- XJTU1AF-CRF-2020-001
- Acronym
- PMFPOEPMWCHI
- Status last verified
- Aug 2021
- First submitted
- 17 Mar 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Model for Prognosis of E Antigen-positive Mothers With Chronic HBV Infection: A Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT04805034
- Acronym / sponsor ID
- PMFPOEPMWCHI / XJTU1AF-CRF-2020-001
- Conditions
- Hepatitis B, Chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Shaanxi Provincial People's Hospital, Baoji Maternal and Child Health Hospital, Weinan Central Hospital, Ankang Central Hospital, Hanzhong Central Hospital, Yan'an University Affiliated Hospital
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 18 Mar 2021 (actual)
- 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.
Pregnancy is a complex and coordinated physiological process. Pregnancy and the postpartum period are associated with unique changes in the immune system that may impact the natural history of autoimmune diseases and immune-mediated infections. In the postpartum period. ALT flares have been reported in 20%-60% of untreated women and were more likely to occur in hepatitis B e antigen (HBeAg)-positive patients. It has been postulated that postpartum ALT flares may arise to rapid immune restitution against hepatitis B virus (HBV) antigens in the liver, when may be a timing of antiviral treatment. A large number of previous studies have focused on studies on the interruption of mother-to-child transmission in women with chronic hepatitis B(CHB), but studies on the prognosis of mothers undergoing pregnancy and delivery are very limited. What are the factors that affect the clearance of HBeAg or HBsAg? What kind of antiviral treatment protocol should be adopted for mothers with CHB? It is not only a problem that needs to be solved urgently in clinical practice, but also can provide some clues for understanding the occurrence and development of HBV infection in women of childbearing age.
Overall, this study intends to carry out a multi-center two-way cohort study on E antigen-positive CHB women in 9 hospitals in Shaanxi Province. To observe the dynamic changes of virological parameters in these patients, figure out the factors of the serum HBsAg loss and HBeAg seroconversion, and establish relevant predictive models.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBeAg positive/HBsAg positive | – | Other: Age, BMI,Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level |
| HBeAg seroconversion /HBsAg loss | – | Other: Age, BMI,Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Mothers with chronic hepatitis B infection
Key inclusion criteria (4 listed)
- Age 20-45 years old
- Serum HBsAg positive> 6 months
- HBeAg positive at delivery
- Good compliance
Key exclusion criteria (4 listed)
- Women who give birth to stillbirth due to various reasons
- Coinfection with HIV,HCV, syphilis or other sexually transmitted diseases
- Severe kidney, cardiovascular, lung, nervous system or immune system diseases
- Who are taking immunotherapy drugs or anti-tumor drugs
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 |
|---|---|---|
| Age, BMI,Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT levelExposure factors: Age, BMI, Family history, Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level | Other | HBeAg positive/HBsAg positive, HBeAg seroconversion /HBsAg loss |
Primary outcome
the rate of HBeAg loss
Time frame: Postpartum 96weeks
the rate of HBeAg seroconversion
Time frame: Postpartum 96weeks
the rate of HBsAg loss
Time frame: Postpartum 96weeks
3 secondary outcomes
the rate of undetectable HBV DNA
Time frame: Postpartum 96weeks
the rate ALT normalization
Time frame: Postpartum 96weeks
Dynamic changes of serum HBsAg, HBeAg, HBV DNA and HBV RNA titer
Time frame: at delivery, 12 weeks, 24 weeks, 48 weeks, 72 weeks, 96 weeks after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Tianyan Chen, phD study chair
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 4 inclusion and 4 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 23 Aug 2021. 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 Tianyan Chen, phD (0086-18991232530, chentianyan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of HBeAg loss (time frame: Postpartum 96weeks). The study lists 3 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 23 Aug 2021.