Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B

Completed · Phase 3

Conditions studied: Chronic Hepatitis B

In brief

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.

Key facts

Study ID

NCT00115245

Run by

Novartis

Starts

2004-11-01

Expected to finish

2006-08-01

Last updated by the study team

2015-05-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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
• Other protocol-defined inclusion criteria may apply.

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
• Other protocol-defined exclusion criteria may apply.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Pasadena, California, United States
• Study site — San Francisco, California, United States
• Study site — Miami, Florida, United States
• Study site — Clayton, Australia
• Study site — Wooloongabba, Australia
• Study site — Calgary, Canada
• Study site — Toronto, Canada
• Study site — Winnipeg, Canada
• Study site — Hong Kong, China
• Study site — Paris, France
• Study site — Singapore, Singapore
• Study site — Seoul, South Korea
• Study site — Taipei, Taiwan
• Study site — Bangkok, Thailand

Full record on ClinicalTrials.gov

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