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

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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Elevated Alanine Aminotransferase Levels Female Urogenital Diseases and Pregnancy Complications Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human High Viral Load Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases Virus Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Gynecology and Obstetrics, The Second Affiliated Hospital of the Southeast University

Nanjing, Jiangsu, 210003, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telbivudine treatment

Drug

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

Primary outcomes

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

Time frame: From late pregnancy to 28 weeks of postpartum

Secondary outcomes

Changes in maternal HBeAg titers and lost/seroconversion of HBeAg or HBsAg

Time frame: From late pregnancy to 28 weeks of postpartum

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Apr 19, 2011
Registry last updated: Apr 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed