CompletedPhase 4

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

China88 participantsStarted 2008-08

Plain-language 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.

Who can participate

Age range20 Years – 40 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The efficacy of Telbivudine treatment (DNA reduction, ALT normalization, and infants' immunoprophylaxis failure) and safety

Timeframe: From late pregnancy to 28 weeks of postpartum

Trial details

NCT IDNCT01337791

SponsorSoutheast University, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-12

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