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Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00131742
Enrollment
Unknown
Registered
2005-08-19
Start date
2004-07-31
Completion date
2007-01-31
Last updated
2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Brief summary

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

Interventions

DRUGtelbivudine
DRUGlamivudine

Sponsors

Novartis Pharmaceuticals
CollaboratorINDUSTRY
Novartis
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
16 Years to 70 Years

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026