Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B

Chronic Hepatitis B Clinical Trial

Official title:

The Efficacy and Safety of Telbivudine and Lamivudine Use in Highly Viremic Mothers to Prevent Hepatitis B Transmission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743079
• Other study ID #: 20080810
• Status: Completed
• Phase: Phase 4
• First received: December 3, 2012
• Last updated: July 29, 2013
• Start date: January 2009
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Beijing YouAn Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationChina: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Complication
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Late Pregnancy
• Transmission

Intervention

Drug:
• Telbivudine
LdT 600mg QD
• Lamivudine
LAM 100mg QD

Locations

Country	Name	City	State
China	Beijing YouAn Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing YouAn Hospital	New Discovery LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety on fetal exposure of telbivudine and lamivudine and vertical transmission rate from mother to child		From gestation week 26 to postpartum week 52	Yes
Secondary	percentage of mothers with serum HBV DNA level reduction, ALT within normal range and HBeAg and/or HBsAg negativity with or without seroconversion		From gestation week 26 to pastpartume week 52	Yes