Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone

Phase 3TerminatedNCT00376259

Novartis43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis B

Interventions

telbivudineDRUG

600mg/day oral tablet for 96 weeks

adefovir dipivoxilDRUG

10 mg of adefovir by mouth once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (6)

Novartis

San Diego, California, United States

Unnamed facility

San Mateo, California, United States

Unnamed facility

Pok Fu Lam, Hong Kong

Unnamed facility

Seoul, South Korea

Novarits

Outcomes

Primary Outcomes

The Proportion of Participants Who Experienced Virologic Breakthrough

Virologic breakthrough is defined as a minimum of 1 log reduction from baseline followed by a 1 log increase from nadir on at least 2 consecutive visits including the last treatment visit.

Time frame: 96 Weeks

Secondary Outcomes

Change From Baseline in Mean Hepatitis B Virus (HBV) DNA Concentration

Efficacy was assessed by the change from baseline in mean HBV DNA concentration after 12, 24, 48 and 60 weeks of treatment.

Time frame: Baseline to 12 weeks, 24 weeks, 48 weeks and 60 weeks

Percentage of Participants Achieving Specified Clinical and Laboratory Safety Criteria

Undetectable HBV DNA = HBV DNA \<300 copies/ml. Serum aminotransferase (ALT) normalization is defined as ALT within normal limits on 2 successive visits for a pt. with an elevated ALT level (\>=1.0 x ULN) at baseline (BL). Hepatitis B e antigen (HBeAg) loss is defined as the loss of detectable serum HBeAg in a pt. who was HBeAg +ve at BL. HBeAg seroconversion is defined as HBeAg loss with detectable HBeAb. Hepatitis B surface antigen (HBsAg) loss is defined as the loss of detectable serum HBsAg in a pt. who was HBsAg +ve at BL. HBsAg seroconversion is defined as HBsAg loss with detectable HBsAb.

Time frame: 12 week, 24 week, 48 week and 60 weeks

Proportion of Participants With Treatment-emergent HBV Resistance Mutations Associated With Virologic Breakthrough

The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA). Patients did not receive 96 weeks of treatment. Therefore, the primary objective of evaluating virologic breakthrough by Week 96 could not be assessed. Consequently, all protocol-specified inferential analyses on the primary endpoint and all other key secondary efficacy endpoints could not be performed.

Time frame: Week 96

Data from ClinicalTrials.gov

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