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Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone

NCT00376259 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2011-06-30

Study results available
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Summary

This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration \[FDA\] for the treatment of hepatitis B virus \[HBV\]) versus adefovir dipivoxil used alone. The results for patients taking the combination therapy will be compared to the results for patients taking adefovir alone.

Conditions

Interventions

DRUG

telbivudine

600mg/day oral tablet for 96 weeks

DRUG

adefovir dipivoxil

10 mg of adefovir by mouth once daily

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
2007-01-31
Primary Completion
2008-08-31

Countries

  • United States
  • Hong Kong
  • South Korea
  • Taiwan
  • Thailand

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 NCT00376259 on ClinicalTrials.gov