Telbivudine Versus Lamivudine for Maintenance Therapy of Patients With Chronic Hepatitis B and Negative HBV Viral Load After 6 Month of Treatment With Telbivudine
NCT01005238 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2015-03-10
Summary
The aim of this randomized clinical study is to show non-inferiority of a change of anti-viral therapy from telbivudine to lamivudine in patients who have achieved an undetectable viral load at week 24 of telbivudine therapy compared to continuous treatment with telbivudine with respect to the viral breakthrough rate at week 108 as the primary clinical outcome.
Conditions
- Hepatitis, Chronic
Interventions
- DRUG
-
Lamivudine
- DRUG
-
Telbivudine
Sponsors & Collaborators
-
University Hospital, Basel, Switzerland
lead OTHER
Principal Investigators
-
Markus Heim, Prof. · University Hospital, Basel, Switzerland
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-09-30
- Primary Completion
- 2014-12-31
Countries
- Switzerland
Study Locations
More Related Trials
-
Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable HBV DNA
NCT00625339 ·Status: COMPLETED ·Phase: PHASE4
-
Study of Telbivudine in Chronic Hepatitis B
NCT00970216 ·Status: COMPLETED
-
A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B
NCT00057265 ·Status: COMPLETED ·Phase: PHASE3
-
Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir
NCT03236584 ·Status: UNKNOWN ·Phase: PHASE3
-
Lamivudine Extending Therapy in Chronic Hepatitis B Patients After 3-year of Oral Antiviral Agents
NCT02337127 ·Status: UNKNOWN ·Phase: PHASE4
-
An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B
NCT00124241 ·Status: COMPLETED ·Phase: PHASE2
-
Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable Hepatitis B Virus DNA
NCT00637663 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy Study of Telbivudine in Chronic Hepatitis B Patients
NCT01958229 ·Status: COMPLETED
-
Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies
NCT00142298 ·Status: COMPLETED ·Phase: PHASE3
-
A Comparison of the Drug Telbivudine (LdT) and Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis.
NCT00275652 ·Status: COMPLETED ·Phase: PHASE3
-
Switch to Tenofovir Versus Continue Lamivudine/Adefovir Treatment in Lamivudine-resistance Chronic Hepatitis B Patients
NCT01491295 ·Status: UNKNOWN ·Phase: PHASE4
-
Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B
NCT00606099 ·Status: WITHDRAWN ·Phase: PHASE4
-
Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT
NCT00230477 ·Status: COMPLETED ·Phase: PHASE4
-
Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B
NCT00115245 ·Status: COMPLETED ·Phase: PHASE3
-
Lamivudine and Adefovir to Treat Chronic Hepatitis B Infection in People With and Without HIV Infection
NCT00023153 ·Status: COMPLETED ·Phase: PHASE3
-
A Single-arm Study Evaluating the Efficacy and Safety of Telbivudine With or Without add-on Tenofovir in Adults With HBeAg-positive Chronic Hepatitis B (CHB)
NCT00651209 ·Status: COMPLETED ·Phase: PHASE4
-
Effects of Telbivudine and Tenofovir Disproxil Fumarate on the Kinetics of Hepatitis B Virus DNA in Chronic Hepatitis B (CHB)
NCT00804622 ·Status: COMPLETED ·Phase: PHASE2
-
Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNA
NCT00625560 ·Status: COMPLETED ·Phase: PHASE4
-
Compare the Efficacy and Safety of 48-week Treatment With Clevudine 30mg Versus Lamivudine 100mg for CHB Infection
NCT00362635 ·Status: COMPLETED ·Phase: PHASE3
-
Treatment of Hepatitis B Virus (HBV) Before Beginning Anti-HIV Drugs in Patients With Both HBV and HIV
NCT00051090 ·Status: WITHDRAWN ·Phase: NA
-
Long-Term Lamivudine Therapy for Chronic Hepatitis B
NCT00120354 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy of Telbivudine Treatment at Long Term on the Absence of Liver Inflammation in Patients With Compensated Chronic Hepatitis B
NCT00877149 ·Status: COMPLETED ·Phase: PHASE4
-
Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone
NCT00376259 ·Status: TERMINATED ·Phase: PHASE3
-
Lamivudine and Adefovir to Treat Chronic Hepatitis B
NCT00023309 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B
NCT01743079 ·Status: COMPLETED ·Phase: PHASE4