Trials / Completed
CompletedNCT01337791
Efficacy, Safety and Tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women With Elevated Alanine Aminotransferase Levels
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- Southeast University, China · Academic / Other
- Sex
- Female
- Age
- 20 Years – 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2008-08-01
- Primary completion
- 2009-12-01
- Completion
- 2009-12-01
- First posted
- 2011-04-19
- Last updated
- 2011-04-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01337791. Inclusion in this directory is not an endorsement.