Efficacy, Safety and Tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women With Elevated Alanine Aminotransferase Levels

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01337791

Enrollment

Registered

2011-04-19

Start date

2008-08-31

Completion date

2009-12-31

Last updated

2011-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B, Elevated Alanine Aminotransferase Levels, High Viral Load, Pregnancy Complications

Keywords

chronic hepatitis B, hepatitis B virus, perinatal transmission, Telbivudine

Brief summary

Telbivudine reduces DNA and normalizes alanine aminotransferase levels (ALT) in chronic hepatitis B patients with few adverse effects, but its use during pregnancy has not been explored. In this open-label, prospective study from the second trimester to post-partum week 28. This trial is to study the efficacy, safety and tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women with high level of serum HBV DNA and elevated alanine aminotransferase levels.

Interventions

DRUGTelbivudine treatment

Two arms in this study, One is Telbivudine 600 mg by mouth daily from late pregnancy to 28 weeks of post partum. Another arm is clinical observation only without telbivudine treatment

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

Inclusion criteria

* age between 20-40 years * gestational age between 12-30 weeks * serum HBsAg and HBeAg positivity * HBV DNA levels \>6log10 copies/mL * ALT \>1x ULN (40 IU/mL) and \< 10x ULN.

Exclusion criteria

* co-infection with hepatitis A, C, D, E or HIV * evidence of hepatocellular carcinoma; decompensated liver disease or significant renal, cardiovascular, respiratory or neurological co-morbidity * concurrent treatment with immune-modulators, cytotoxic drugs, or steroids * clinical signs of threatened miscarriage in early pregnancy * evidence of fetal deformity by 3-dimensional ultrasound examination * the biological father of the child had CHB

Design outcomes

Primary

Measure	Time frame
The efficacy of Telbivudine treatment (DNA reduction, ALT normalization, and infants' immunoprophylaxis failure) and safety	From late pregnancy to 28 weeks of postpartum

Secondary

Measure	Time frame
Changes in maternal HBeAg titers and lost/seroconversion of HBeAg or HBsAg	From late pregnancy to 28 weeks of postpartum

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026