Clinical trial NCT01743079: Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B
Official title: The Efficacy and Safety of Telbivudine and Lamivudine Use in Highly Viremic Mothers to Prevent Hepatitis B Transmission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis B
Late Pregnancy
Transmission
Complication
Keywords: Telbivudine
Lamivudine
safety
efficacy
pregnancy
Lead sponsor: Beijing YouAn Hospital
Sponsor class: OTHER
Collaborators: name: New Discovery LLC
First posted: 2012-12-06
Enrollment: 700
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy and safety of telbivudine and lamivudine use during late pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.

Detailed description: This study enrolls HBV mono-infected pregnant women cohorts managed in outpatient clinics/delivery unit at YouAn Hospital in Beijing. Subjects are prospectively followed from gestation week 26 to postpartum week 52. Treatment naïve mothers with HBV DNA \> 6 log10 c/mL and normal ALT are eligible. Mothers with abnormal fetus, cirrhosis or evidence of hepatocellular carcinoma (HCC) are excluded. At gestation week 28, mothers will receive telbivudine (LdT) 600 mg per day or lamivudine (Lam) 100 mg per day until postpartum 4 or no treatment as per their preference. All infants will receive standard immunoprophylaxis. Data is collected from patient records using data extraction forms. Primary endpoints are vertical transmission rates at infants' age of 52 week and the safety of telbivudine or lamivudine use.

Eligibility criteria: Inclusion Criteria:

1. Age: 20-40 years old
2. HBsAg, HBeAg positive and HBV DNA \>6 log10 copies/ml
3. Gestational age: 26-28 weeks with normal fetus
4. Willing to consent for the study

Exclusion Criteria:

1. Elevated ALT
2. Antiviral treatment experience patients
3. Co-infection with HAV, HCV,HDV, HIV
4. Concurrent treatment with immune modulators, cytotoxic drugs, or steroids
5. Clinical signs of threatened miscarriage in early pregnancy
6. Clinical evidence of cirrhosis and/or hepatocellular carcinoma

Primary outcomes:
measure: Safety on fetal exposure of telbivudine and lamivudine and vertical transmission rate from mother to child
timeFrame: From gestation week 26 to postpartum week 52
Secondary outcomes:
measure: percentage of mothers with serum HBV DNA level reduction, ALT within normal range and HBeAg and/or HBsAg negativity with or without seroconversion
timeFrame: From gestation week 26 to pastpartume week 52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing YouAn Hospital
state: Beijing
Study officials:
affiliation: Division of Liver Diseases, Mount Sinai School of Medicine, Flushing, NY
name: Calvin Pan, MD
role: STUDY_DIRECTOR
affiliation: Beijing YouAn Hospital
name: Hua Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang H, Pan CQ, Pang Q, Tian R, Yan M, Liu X. Telbivudine or lamivudine use in late pregnancy safely reduces perinatal transmission of hepatitis B virus in real-life practice. Hepatology. 2014 Aug;60(2):468-76. doi: 10.1002/hep.27034. Epub 2014 Jan 27.