Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B
A Randomized, Open-Label Trial of Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B
1 other identifier
interventional
N/A
9 countries
15
Brief Summary
This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved by the Food and Drug Administration (FDA) for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking adefovir dipivoxil.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2004
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 21, 2005
CompletedFirst Posted
Study publicly available on registry
June 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedMay 12, 2015
May 1, 2015
1.7 years
June 21, 2005
May 8, 2015
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Documented compensated chronic hepatitis B defined by clinical history compatible with compensated chronic hepatitis B
- Detectable serum HBsAg at the Screening visit
You may not qualify if:
- Patient is pregnant or breastfeeding.
- Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV
- Patient previously received lamivudine, adefovir dipivoxil, or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide analog at any time
- Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
- Novartis Pharmaceuticalscollaborator
Study Sites (15)
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Pasadena, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Clayton, Australia
Unknown Facility
Wooloongabba, Australia
Unknown Facility
Calgary, Canada
Unknown Facility
Toronto, Canada
Unknown Facility
Winnipeg, Canada
Unknown Facility
Hong Kong, China
Unknown Facility
Paris, France
Unknown Facility
Singapore, Singapore
Unknown Facility
Seoul, South Korea
Unknown Facility
Taipei, Taiwan
Unknown Facility
Bangkok, Thailand
Related Publications (1)
Chan HL, Heathcote EJ, Marcellin P, Lai CL, Cho M, Moon YM, Chao YC, Myers RP, Minuk GY, Jeffers L, Sievert W, Bzowej N, Harb G, Kaiser R, Qiao XJ, Brown NA; 018 Study Group. Treatment of hepatitis B e antigen positive chronic hepatitis with telbivudine or adefovir: a randomized trial. Ann Intern Med. 2007 Dec 4;147(11):745-54. doi: 10.7326/0003-4819-147-11-200712040-00183. Epub 2007 Oct 1.
PMID: 17909201DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 21, 2005
First Posted
June 22, 2005
Study Start
November 1, 2004
Primary Completion
August 1, 2006
Study Completion
August 1, 2006
Last Updated
May 12, 2015
Record last verified: 2015-05