Telbivudine Therapy in HBeAg-positive Pregnant Women to Prevent Mother-to-infant Transmission of HBV
This study is currently recruiting participants.
Verified August 2012 by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor:
Yi-Hua Zhou
Collaborator:
Taixing People's Hospital
Information provided by (Responsible Party):
Yi-Hua Zhou, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier:
NCT01637844
First received: July 4, 2012
Last updated: August 5, 2012
Last verified: August 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HBV |
Drug: Telbivudine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Telbivudine in the Third Trimester of Pregnancy to Prevent Mother-to-infant Transmission of HBV |
Resource links provided by NLM:
Further study details as provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
Primary Outcome Measures:
- HBV serologic markers and alanine transaminase (ALT) levels in infants [ Time Frame: 10 months after birth ] [ Designated as safety issue: No ]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 [ Time Frame: Up to 10 months postpartum ] [ Designated as safety issue: No ]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 [ Time Frame: Up to 10 months after delivery/birth ] [ Designated as safety issue: Yes ]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).
| Estimated Enrollment: | 240 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
- With pregnant complications such as pregnancy hypertension, preeclampsia, etc
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637844
Contacts
| Contact: Yi-Hua Zhou, MD, PhD | +86 25 8330 4616 ext 10373 | yzh20061111@yahoo.com |
| Contact: Yali Hu, MD, PhD | +86 25 8330 4616 ext 66808 | dtylhu@126.com |
Locations
| China, Jiangsu | |
| Nanjing Drum Tower Hospital | Recruiting |
| Nanjing, Jiangsu, China, 210008 | |
| Contact: Yi-Hua Zhou, MD, PhD +86 25 8330 4616 ext 10373 yzh20061111@yahoo.com | |
| Principal Investigator: Yi-Hua Zhou, MD, PhD | |
| Principal Investigator: Yali Hu, MD, PhD | |
| Taixing People's Hospital | Recruiting |
| Taixing, Jiangsu, China, 225400 | |
| Contact: Biao Xu, MD 89110541@qq.com | |
| Principal Investigator: Biao Xu, MD | |
| Zhenjiang Fourth People's Hospital | Recruiting |
| Zhenjiang, Jiangsu, China, 212001 | |
| Contact: Jian Wen, MD 77304270@qq.com | |
| Principal Investigator: Jian Wen, MD | |
Sponsors and Collaborators
Yi-Hua Zhou
Taixing People's Hospital
Investigators
| Study Director: | Yali Hu, MD, PhD | Nanjing Drum Tower Hospital, Nanjing University Medical School |
More Information
Publications:
| Responsible Party: | Yi-Hua Zhou, Professor of Infectious Diseases, Chair of Experimental Medicine, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| ClinicalTrials.gov Identifier: | NCT01637844 History of Changes |
| Other Study ID Numbers: | 2012019 |
| Study First Received: | July 4, 2012 |
| Last Updated: | August 5, 2012 |
| Health Authority: | China: Ministry of Health |
Keywords provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
|
Pregnant women HBsAg positive HBeAg positive Telbivudine |
ClinicalTrials.gov processed this record on May 22, 2013