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

NCT01337791 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2011-04-19

No results posted yet for this study

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

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

Interventions

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

Sponsors & Collaborators

  • Southeast University, China

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01337791 on ClinicalTrials.gov