Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B
Information source: Idenix Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis B
Intervention: Telbivudine (LdT) (Drug); Adefovir Dipivoxil (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Idenix Pharmaceuticals
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.
Clinical Details
Official title: A Randomized, Open-Label Trial of Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Locations and Contacts
Wooloongabba, Australia
Clayton, Australia
Toronto, Canada
Calgary, Canada
Winnipeg, Canada
Hong Kong, China
Paris, France
Seoul, Korea, Republic of
Singapore, Singapore
Taipei, Taiwan
Bangkok, Thailand
San Francisco, California, United States
Los Angeles, California, United States
Pasadena, California, United States
Miami, Florida, United States
Additional Information
Last updated: March 1, 2007
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