Chronic Hepatitis B Clinical Trial
Verified date | April 2011 |
Source | Southeast University, China |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 88 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Department of Gynecology and Obstetrics, The Second Affiliated Hospital of the Southeast University | Nan Jing | Jiang Su |
Lead Sponsor | Collaborator |
---|---|
Southeast University, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The efficacy of Telbivudine treatment (DNA reduction, ALT normalization, and infants' immunoprophylaxis failure) and safety | From late pregnancy to 28 weeks of postpartum | Yes | |
Secondary | Changes in maternal HBeAg titers and lost/seroconversion of HBeAg or HBsAg | From late pregnancy to 28 weeks of postpartum | No |
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