Chronic Hepatitis B InfectionNCT04135235
Effect and Safety of Propofol Fumarate for Mother-to-child Blocking of Hepatitis B
An observational study of Chronic Hepatitis B Infection and High Viral Load, run by Beijing Ditan Hospital at 1 site in China.
Trial summary
This study is a prospective study. The subject will select 440 cases of pregnant women with high hepatitis B virus load, and one group will take maternal and child blockade treatment with propofol fumarate. One group will take tenofovir disoproxil fumarate. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Chronic Hepatitis B Infection, High Viral Load
- What is being tested?
- TAF and TDF
- How many people
- 440 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 1 Aug 2021
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: High HBV viral load (HBV DNA ≥ 106 IU / mL) pregnant women with chronic HBV infection. All pregnant women with chronic HBV infection were in compliance with the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015).
Who may be able to join
- No nucleoside analog antiviral drugs have been used in the past.
- HBsAg and HBeAg double positive, HBV DNA>106 IU/mL.
- Fully inform the risk to voluntarily join the study and sign the informed consent form.
Who cannot join
- Combine other viral infections: such as HCV, HIV, CMV, etc.;
- amniocentesis during pregnancy;
- Liver cirrhosis and liver cancer;
- Other autoimmune diseases and liver diseases;
- fetal ultrasound screening in early and middle pregnancy found deformity.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100015
Wei Yi, 13683687062, yiwei1215@163.com
Yao Xie, 13501093293, xieyao00120184@sina.com
About this study
Official title: The Effect and Safety of Propofol Fumarate for Mother-to-child Blocking of Hepatitis B
This study is a prospective study. The subject will select 440 cases of pregnant women with high hepatitis B virus load, and one group will take maternal and child blockade treatment with propofol fumarate. One group will take tenofovir disoproxil fumarate. Broken treatment, compare the failure rate of maternal and child blockade and the incidence of maternal and child adverse events in the two groups, and explore the efficacy and safety of propofol flavuril for the treatment of hepatitis B mother-infant block.
Read the detailed description
This study was a prospective cohort study. Because propofolofofovir is not covered by medical insurance and is more expensive, and there are factors such as renal function damage and the risk factors that can not use tenofovir, it is difficult to conduct randomized controlled cases. The subject will select 440 cases of pregnant women with high hepatitis B virus load. After signing the informed consent form, according to the patient's wishes, one group will take the mother-infant blockade of propofol fumarate, and one group will take fumaric acid. In the case of maternal and child blockade of benifovir, the incidence of maternal and child block failure and the incidence of maternal and child adverse events were compared between the two groups, and propofol fumarate was used for maternal and child blockade of hepatitis B. The effectiveness and safety of the treatment.
- Conditions
- Chronic Hepatitis B Infection, High Viral Load
- Being tested
- TAF, TDF
- Keywords
- Chronic Hepatitis B, Pregnant woman, High viral load, Tenofovir fumarate
- 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.
TAFDrug
Propofol tenofovir fumarate
TDFDrug
Dipirofurate fumarate tenofovir
| Study group | Role | What they receive |
|---|---|---|
| TAF group | take propofol fumarate for Maternal and child blockade treatment Receives: Drug: TAF | |
| TDF group | take difenofurate fumarate for Maternal and child blockade treatment Receives: Drug: TDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
the blocking successful rate of HBV mother-to-child transmission
HBV mother-to-child transmission blocking success rate (negative HBsAg and HBV DNA negative 7 months after birth)
Measured: 7 months after birth
Secondary outcomes (2)
The incidence of abnormal growth
The incidence of abnormal growth at birth
Measured: at birth, at the 7 months after birth
The incidence of abnormal development
The incidence of abnormal development at birth
Measured: at birth, at the 7 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start1 Aug 2019
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Ditan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Yi, Beijing Ditan Hospital
- Investigators
- Wei Yi, Doctor, Principal investigator, Beijing Ditan HospitalYao Xie, Doctor, Principal investigator, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135235
- Sponsor's protocol ID
- KY2019-08
- Status last verified
- Oct 2019
- First submitted
- 12 Oct 2019
- Last updated
- 22 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Safety of Propofol Fumarate for Mother-to-child Blocking of Hepatitis B
- ClinicalTrials.gov ID
- NCT04135235
- Acronym / sponsor ID
- KY2019-08
- Conditions
- Chronic Hepatitis B Infection, High Viral Load
- Keywords
- Chronic Hepatitis B, Pregnant woman, High viral load, Tenofovir fumarate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 22 Oct 2019 (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.
This study is a prospective study. The subject will select 440 cases of pregnant women with high hepatitis B virus load, and one group will take maternal and child blockade treatment with propofol fumarate. One group will take tenofovir disoproxil fumarate. Broken treatment, compare the failure rate of maternal and child blockade and the incidence of maternal and child adverse events in the two groups, and explore the efficacy and safety of propofol flavuril for the treatment of hepatitis B mother-infant block.
Detailed description
This study was a prospective cohort study. Because propofolofofovir is not covered by medical insurance and is more expensive, and there are factors such as renal function damage and the risk factors that can not use tenofovir, it is difficult to conduct randomized controlled cases. The subject will select 440 cases of pregnant women with high hepatitis B virus load. After signing the informed consent form, according to the patient's wishes, one group will take the mother-infant blockade of propofol fumarate, and one group will take fumaric acid. In the case of maternal and child blockade of benifovir, the incidence of maternal and child block failure and the incidence of maternal and child adverse events were compared between the two groups, and propofol fumarate was used for maternal and child blockade of hepatitis B. The effectiveness and safety of the treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAF group | – | Drug: TAFtake propofol fumarate for Maternal and child blockade treatment |
| TDF group | – | Drug: TDFtake difenofurate fumarate for Maternal and child blockade treatment |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- High HBV viral load (HBV DNA ≥ 106 IU / mL) pregnant women with chronic HBV infection. All pregnant women with chronic HBV infection were in compliance with the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015).
Key inclusion criteria (3 listed)
- No nucleoside analog antiviral drugs have been used in the past.
- HBsAg and HBeAg double positive, HBV DNA>106 IU/mL.
- Fully inform the risk to voluntarily join the study and sign the informed consent form.
Key exclusion criteria (5 listed)
- Combine other viral infections: such as HCV, HIV, CMV, etc.;
- amniocentesis during pregnancy;
- Liver cirrhosis and liver cancer;
- Other autoimmune diseases and liver diseases;
- fetal ultrasound screening in early and middle pregnancy found deformity.
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 |
|---|---|---|
| TAFPropofol tenofovir fumarate | Drug | TAF group |
| TDFDipirofurate fumarate tenofovir | Drug | TDF group |
Primary outcome
the blocking successful rate of HBV mother-to-child transmission
Time frame: 7 months after birth
HBV mother-to-child transmission blocking success rate (negative HBsAg and HBV DNA negative 7 months after birth)
2 secondary outcomes
The incidence of abnormal growth
Time frame: at birth, at the 7 months after birth
The incidence of abnormal development
Time frame: at birth, at the 7 months after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
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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 Yi, Doctor principal investigator
Beijing Ditan Hospital
Yao Xie, Doctor principal investigator
Beijing Ditan Hospital
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 Chronic Hepatitis B Infection and High Viral Load, run by Beijing Ditan 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 3 inclusion and 5 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 22 Oct 2019. 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 Wei Yi, Doctor (13683687062, yiwei1215@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the blocking successful rate of HBV mother-to-child transmission (time frame: 7 months after birth). 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 22 Oct 2019.