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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00376259
Other study ID # CLDT600A2304
Secondary ID
Status Terminated
Phase Phase 3
First received September 13, 2006
Last updated June 28, 2011
Start date January 2007

Study information

Verified date June 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 43
Est. completion date
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
telbivudine
600mg/day oral tablet for 96 weeks
adefovir dipivoxil
10 mg of adefovir by mouth once daily

Locations

Country Name City State
Taiwan Novarits Kaohsuing
United States Novartis San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Hong Kong,  Korea, Republic of,  Taiwan,  Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 96 Weeks Yes
Secondary 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. Baseline to 12 weeks, 24 weeks, 48 weeks and 60 weeks Yes
Secondary 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. 12 week, 24 week, 48 week and 60 weeks No
Secondary 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. Week 96 No
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