Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone

Novartis

Status and phase: Terminated; Phase 3

Conditions: Hepatitis B

Treatments: Drug: adefovir dipivoxil; Drug: telbivudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00376259

CLDT600A2304

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Combination therapy

Experimental group

Description:

Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.

Treatment:

Drug: adefovir dipivoxil

Drug: telbivudine

Adefovir monotherapy

Active Comparator group

Description:

Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.

Treatment:

Drug: adefovir dipivoxil