Chronic Hepatitis bNCT03181607
Efficacy and Adverse Effects of Nucleoside Analogues (TDF/LDT) in Preventing Mother-to-child Transmission of HBV
An observational study of Chronic Hepatitis b and Women, run by Xingfei Pan at 1 site in China.
Trial summary
Mother-to-Child-Transmission (MTCT) of HBV is the most important route in high endemic countries. Although active-passive immune prophylaxis is generally administrated to infants delivered by HBsAg positive women, there are a lot of people infected with HBV in China. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Chronic Hepatitis b, Women
- How many people
- 153 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 2022
- Phase
- Observational
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
Study population: Child-bearing age women with chronic HBV infection, who already become pregnant or plan to become pregnant recently,and visit in our hospital, are enrolled.
Who may be able to join
- Age of 20-40 years.
- The history of HBV infection ≥6 months.
- Positive for HBsAg.
- For immune-tolerant patients, HBV DNA load of ≥ 10^6IU/ml at 24-28 weeks of gestation.
- For patients already administrated with nucleoside analogues (NA) treatment, the therapy could be not discontinued and TDF or LDT should be used to treat these patients.
- For patients never administrated with NA treatment, ALT ≥2 times of the upper limit of normal (ULN), HBV DNA load of ≥ 10^4IU/ml (positive for HBeAg) or HBV DNA load of ≥ 10^3IU/ml (negative for HBeAg), traditional protecting liver and reducing enzyme treatment was failed.
- The good compliance of patients.
Who cannot join
- Patients with antibodies against HIV, HCV, HDV, or other forms of chronic liver disease.
- Evidence of hepatocellular carcinoma, decompensated liver disease, auto-immune hepatitis, or significant renal, cardiovascular, respiratory or neurological comorbidity.
- Concurrent treatment with nephrotoxic drugs, glucocorticoids, cytotoxic drugs, nonsteroidal anti-inflammatory drugs, or immune modulators.
- Ultra-sonographic evidence of fetal deformity, abnormal fetal development or placental abnormality.
- Clinical signs of threatened miscarriage.
- History of complication of pregnancy.
- Presence of chronic HBV infection in the biologic father.
Trial locations and contacts
1 site in 1 country.
China1 site
The 3rd Affiliated Hospital, Guangzhou Medical University
Guanzhou, Guangdong, 510150
About this study
Official title: The 3rd Affiliated Hospital, Guangzhou Medical University
Mother-to-Child-Transmission (MTCT) of HBV is the most important route in high endemic countries. Although active-passive immune prophylaxis is generally administrated to infants delivered by HBsAg positive women, there are a lot of people infected with HBV in China. High HBV DNA load (>10^5IU/ml) is the vital cause of MTCT. So some researchers used TDF （tenofovir） or LDT（telbivudine） to treat patients with high HBV DNA load during middle, late pregnancy, in order to decrease MTCT. As a result, some data about it were gradually reported in late years. Recently, American Association for the Study of Liver Diseases, European Association for the Study of Liver Diseases and China guidelines for CHB (chronic hepatitis B) suggest that pregnant women with high HBV DNA load be treated with TDF or LDT at 24-28 weeks of gestation to lower MTCT of HBV.
Although TDF or LDT is classified as pregnancy B drugs by FDA, and many studies report that MTCT rate of HBV decreases after women with high HBV DNA load are administrated with TDF or LDT at 24-28 weeks of gestation, a few birth defects are reported. Furthermore, the long-effect of TDF or LDT on infants remains unclear thoroughly.
Read more
Some CHB women had severe liver dysfunction before pregnancy or during pregnancy, and routine liver protection therapy could not effect. Some of them could develop into liver failure, fibrosis, cirrhosis, and even died. Moreover, severe liver dysfunction often leads to adverse effects to pregnant women and fetuses, such as pregnancy failure, lower weight, premature birth, etc. As a result, these women have to accept TDF or LDT before pregnancy, or during early pregnancy. So the long-effect of TDF or LDT on infants needs thoroughly investigating.
Taken together, the investigators will enroll women with chronic HBV infection and evaluate their state of illness. Then the investigators treat participants with TDF or LDT or routine liver protection therapy, and follow up the participants for a long period. The investigators' objectives are as follows:
A, To clarify efficacy and adverse effects of TDF/LDT in preventing MTCT between immune-tolerant and immune-active CHB patients.
B, To clarify efficacy and adverse effects of TDF/LDT in preventing MTCT during different trimesters of pregnancy.
C, To compare MTCT rate between patients received TDF/LDT therapy and patients without TDF/LDT therapy.
D, To compare MTCT rate and adverse effects between LDT and TDF.
- Conditions
- Chronic Hepatitis b, Women
- Medical subject headings
- Hepatitis B, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of hepatitis B infections in the infants at 1 year of age
Testing for HBsAg in the infants between 7 and 12 months of age
Measured: Between 7-12 months after birth
Secondary outcomes (5)
The proportion of birth defects in the infants at 1 month age
Measuring the number of infants with congenital abnormality
Measured: From birth to 1 month age
Growth parameters of the infants
The infants'physical development status (head circumference, weight, and height) is measured and analyzed, respectively. Denver Developmental Screening Test is also analyzed.
Measured: From birth to 5 years age
HBV DNA quantification of mothers
HBV DNA quantification is detected at 24-28 weeks of gestation, at birth, every 6 month after postpartum.
Measured: From time of the inclusion to 5 years.
ALT levels of mothers
ALT levels are measured every month during pregnancy and the first 3 months postpartum, and every 6 month from the fourth month of postpartum.
Measured: From time of the inclusion to 5 years.
HBeAg conversion rate of mothers
HBeAg quantification is measured every 6 month.
Measured: From time of the inclusion to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start1 Jan 2017
- Primary completion26 May 2019
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xingfei Pan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xingfei Pan, The Third Affiliated Hospital of Guangzhou Medical University
- Investigators
- Xingfei Pan, Dr., Study director, The 3rd Affiliated Hospital, Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181607
- Sponsor's protocol ID
- [2017] No.157
- Status last verified
- Nov 2021
- First submitted
- 2 Jun 2017
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No