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NCT00131742 Clinical Trial

Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00131742
Other study ID # NV-02B-015
Secondary ID
Status Completed
Phase Phase 3
First received August 18, 2005
Last updated May 8, 2015
Start date July 2004
Est. completion date January 2007

Study information
Verified date May 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationChina: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study is being conducted to compare the effectiveness and safety of telbivudine (LdT) and lamivudine in Chinese adults.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date January 2007
Est. primary completion date January 2007
Accepts healthy volunteers
Gender Both
Age group 16 Years to 70 Years
Eligibility Inclusion Criteria:

- Documented clinical history compatible with chronic hepatitis B infection

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 previously received lamivudine or any investigational anti-HBV nucleoside or nucleotide analog

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

• lamivudine

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Novartis Novartis Pharmaceuticals

Country where clinical trial is conducted

China, 

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