Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone

Stopped early · Phase 3

Conditions studied: Hepatitis B

In brief

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.

Key facts

Study ID

NCT00376259

Run by

Novartis

People needed

43

Starts

2007-01-01

Last updated by the study team

2011-06-30

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 a clinical history compatible with chronic hepatitis B.
• Previous or current lamivudine treatment
• HBV DNA > 6 log10 copies/mL
• Evidence of viral breakthrough
• Other protocol-defined inclusion criteria may apply.

You may not qualify if…

• Patient is pregnant or breastfeeding.
• Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV.
• Patient has received any anti-HBV treatment for HBV infection other than lamivudine in the 12 months before Screening for this study.
• Other protocol-defined exclusion criteria may apply.

Where it is running

• Novartis — San Diego, California, United States
• Study site — San Mateo, California, United States
• Study site — Pok Fu Lam, Hong Kong
• Study site — Seoul, South Korea
• Novarits — Kaohsuing, Taiwan
• Study site — Bangkok, Thailand

Full record on ClinicalTrials.gov

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