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

Chronic Hepatitis B Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01337791
• Other study ID #: H200804IRB
• 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

Related Conditions & MeSH terms

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

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