Telbivudine Therapy in HBeAg-positive Pregnant Women to Prevent Mother-to-infant Transmission of HBV
Study Details
Study Description
Brief Summary
Infants of hepatitis B virus (HBV)-infected mothers with positive hepatitis B e antigen (HBeAg) have an increased risk of becoming infected with HBV. This study will determine whether telbivudine among both hepatitis B surface antigen (HBsAg) and HBeAg positive pregnant women during the third trimester, in addition to standard immunoprophylaxis in infants, will be more effective than standard immunoprophylaxis alone at preventing HBV infections in these infants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
Infants of HBV-infected mothers with positive HBeAg have an increased risk of becoming infected with HBV. Standard immunoprophylaxis against mother-to-infant transmission of HBV includes administration of hepatitis B immunoglobulin (HBIG) and hepatitis B vaccine; however, approximately 5-15% of the infants are not protected despite having received these preventive measures. It is reported that antiviral prophylaxis among HBV-infected pregnant women can reduce mother-to-infant transmission of HBV. However, more research is needed to obtain the definite conclusion. This study will determine whether telbivudine among HBsAg- and HBeAg-positive pregnant women during the third trimester, in addition to standard immunoprophylaxis in infants, will be more effective than standard immunoprophylaxis alone at preventing HBV infections in these infants.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Telbivudine HBsAg- and HBeAg-positive pregnant women at 28-32 weeks of gestation start to orally take telbivudine (600 mg/day) until 4 weeks after delivery. Newborn infants receive standard immunoprophylaxis. |
Drug: Telbivudine
HBsAg- and HBeAg-positive pregnant women at 28-32 weeks of gestation are given with telbivudine (oral 600 mg/day) until 4 weeks after delivery. Newborn infants are administered 100-200 IU HBIG within 12 hours after birth and vaccinated against hepatitis B with yeast recombinant hepatitis B vaccine (10 µg) at 0, 1, and 6-month schedule. HBV DNA and ALT levels are measured before the use of telbivudine, at delivery, and 1-2 months after stopping the drug. HBV serological markers, including HBsAg, anti-HBs, and anti-HBc, HBeAg and anti-HBe are tested in infants at age of 7-12 months.
Other Names:
|
| No Intervention: Control Infants of HBsAg- and HBeAg-positive women who are not treated with telbivudine and any other antiviral agents serve as controls. The infants are administered standard immunoprophylaxis against mother-to-infant transmission of HBV, 100-200 IU hepatitis B immunoglobulin (HBIG) within 12 hours after birth and three doses hepatitis B vaccine at 0, 1 and 6-month schedule. |
Outcome Measures
Primary Outcome Measures
- HBV serologic markers and alanine transaminase (ALT) levels in infants [10 months after birth]
HBsAg and HBeAg are tested in umbilical blood and peripheral blood collected at the age of 10 months respectively. ALT is measured at 10 months old.
Secondary Outcome Measures
- HBV DNA quantification and ALT levels in mothers [Up to 10 months postpartum]
HBV DNA and ALT levels in the pregnant women are measured before taking telbivudine, at birth, 1-2 months after stopping the drug, and 10 months postpartum.
- Women and infants with adverse events [Up to 10 months after delivery/birth]
Adverse events in pregnant women during pregnancy, complications at delivery and postpartum, Apgar score, newborn infant deformity, infant growth and development will be recorded during the study period (up to 10 months after delivery/birth).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
pregnant women at 28-32 weeks of gestation
-
both HBsAg and HBeAg positive
-
good compliance
Exclusion Criteria:
-
Coinfection of HAV, HCV, HEV, HIV, and STD
-
With history of antiviral treatment against HBV
-
With chronic disease, such as heart and kidney disease, asthma, diabetes, hyperthyroidism, severe anemia, bleeding disease, autoimmune diseases
-
With threatened miscarriage or relevant treatment during the pregnancy
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With pregnant complications such as pregnancy hypertension, preeclampsia, etc
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With history of fetal deformity, or fetal deformity detected by ultrasound examination
-
With ALT >10 times upper limit, or total bilirubin >3 times upper limit, of normal value
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nanjing Drum Tower Hospital | Nanjing | Jiangsu | China | 210008 |
| 2 | Taixing People's Hospital | Taixing | Jiangsu | China | 225400 |
| 3 | Zhenjiang Fourth People's Hospital | Zhenjiang | Jiangsu | China | 212001 |
Sponsors and Collaborators
- Yi-Hua Zhou
- Taixing People's Hospital
- Fourth People's Hospital of Zhenjiang, China
- Wuxi Maternal and Child Health Hospital
- Kunshan First People Hospital
Investigators
- Study Director: Yali Hu, MD, PhD, Nanjing Drum Tower Hospital, Nanjing University Medical School
Study Documents (Full-Text)
None provided.More Information
Publications
- Han GR, Cao MK, Zhao W, Jiang HX, Wang CM, Bai SF, Yue X, Wang GJ, Tang X, Fang ZX. A prospective and open-label study for the efficacy and safety of telbivudine in pregnancy for the prevention of perinatal transmission of hepatitis B virus infection. J Hepatol. 2011 Dec;55(6):1215-21. doi: 10.1016/j.jhep.2011.02.032. Epub 2011 Apr 15.
- Pan CQ, Han GR, Jiang HX, Zhao W, Cao MK, Wang CM, Yue X, Wang GJ. Telbivudine prevents vertical transmission from HBeAg-positive women with chronic hepatitis B. Clin Gastroenterol Hepatol. 2012 May;10(5):520-6. doi: 10.1016/j.cgh.2012.01.019. Epub 2012 Feb 14.
- 2012019