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NCT00057265 Clinical Trial

A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

Official title:
A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00057265
Other study ID # NV-02B-007
Secondary ID
Status Completed
Phase Phase 3
First received March 28, 2003
Last updated March 19, 2015
Start date February 2003

Study information
Verified date March 2015
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) with Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking Lamivudine.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date April 2006
Accepts healthy volunteers
Gender Both
Age group 16 Years to 70 Years
Eligibility Inclusion Criteria:

- Chronic Hepatitis B, documented by Clinical history compatible with chronic HBV

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), HIV-1 or HIV-2.

- Patient previously received lamivudine or an investigational anti-HBV nucleoside or nucleotide analog at any time

- Patient has received interferon or other immunomodulatory treatment for HBV infection 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: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• telbivudine or lamivudine

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Novartis Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Korea, Republic of,  Spain,  Thailand,  Turkey,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary efficacy endpoint: "therapeutic response", defined as reduction of serum HBV DNA to below 5 log10 copies/mL, coupled with normalization of serum alanine aminotransferase levels OR loss of detectable serum HBeAg.
Secondary Secondary efficacy endpoints: Improvement of liver histology, serum HBV DNA changes, normalization of serum alanine aminotransferase levels, HBeAg and HBsAg loss and seroconversion.
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