MedTrace Logo

Efficacy and Safety of Telbivudine in Treatment naïve Patients With Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB)

NCT00412750 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2011-07-13

Study results available
· View outcomes & findings →

Summary

To evaluate the combination of telbivudine 600 mg orally (PO) once daily and peginterferon alpha-2a 180 ug subcutaneous (sq) injection weekly for antiviral efficacy in comparison to peginterferon alpha-2a monotherapy.

Conditions

Interventions

DRUG

Telbivudine (LdT)

600 mg orally once daily for 104 weeks.

DRUG

peginterferon alpha-2a

180 μg subcutaneous injection once a week for 52 weeks.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00412750 on ClinicalTrials.gov