Status:
COMPLETED
Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B
Lead Sponsor:
Novartis
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 Admi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00115245
Start Date
November 1 2004
End Date
August 1 2006
Last Update
May 12 2015
Active Locations (15)
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1
Los Angeles, California, United States
2
Pasadena, California, United States
3
San Francisco, California, United States
4
Miami, Florida, United States