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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01337791
Other study ID # H200804IRB
Secondary ID
Status Completed
Phase Phase 4
First received April 15, 2011
Last updated April 18, 2011
Start date August 2008
Est. completion date December 2009

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

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


Intervention

Drug:
Telbivudine 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

Locations

Country Name City State
China Department of Gynecology and Obstetrics, The Second Affiliated Hospital of the Southeast University Nan Jing Jiang Su

Sponsors (1)

Lead Sponsor Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

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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