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To Evaluate Antiviral Efficacy of Telbivudine in Hepatitis B Antigen Positive (HbeAg-positive) Compensated Chronic Hepatitis B (CHB)

NCT00537537 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-06-23

No results posted yet for this study

Summary

This study is to evaluate the antiviral efficacy of add-on adefovir to telbivudine in non-responders to telbivudine monotherapy after 24 and 36 initial weeks. Antiviral efficacy is assessed by hepatitis B virus (HBV) DNA non-detectability (PCR \<300 copies/ml) by week 104 with CHB.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Telbivudine

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2011-06-30

Countries

  • India

Study Locations

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Entities

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 NCT00537537 on ClinicalTrials.gov