Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Adefovir; Adefovir dipivoxil; Lamivudine; Telbivudine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.