An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B
NCT00467545 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2017-06-23
Summary
This study is to evaluate the safety of telbivudine for up to 21 months of open-label treatment in patients with chronic hepatitis B who have completed the CLDT600A2407 trial. Patients treated with telbivudine during core phase will continue telbivudine and patients treated with entecavir during core phase will be switched to telbivudine if the patient is willing to enroll this study.
Conditions
Interventions
- DRUG
-
telbivudine
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis · Novartis
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-04-30
- Primary Completion
- 2009-09-30
- Completion
- 2009-09-30
Countries
- South Korea
Study Locations
More Related Trials
-
Effects of Telbivudine and Tenofovir Disoproxil Fumarate Treatment on the Hepatitis B Virus DNA Kinetics in CHB
NCT00805675 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B
NCT00057265 ·Status: COMPLETED ·Phase: PHASE3
-
Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine
NCT00640588 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis B
NCT00907894 ·Status: COMPLETED ·Phase: PHASE1
-
Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B
NCT00132652 ·Status: COMPLETED ·Phase: PHASE3
-
Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Entecavir Plus Tenofovir
NCT03236610 ·Status: UNKNOWN ·Phase: PHASE3
-
To Evaluate Antiviral Efficacy of Telbivudine in Hepatitis B Antigen Positive (HbeAg-positive) Compensated Chronic Hepatitis B (CHB)
NCT00537537 ·Status: COMPLETED ·Phase: PHASE4
-
Prospective Exploratory Study to Evaluate the Safety and Efficacy of Telbivudine in the Fifth Year of Treatment in Chinese Patients With Compensated Chronic Hepatitis B
NCT00646503 ·Status: COMPLETED ·Phase: PHASE4
-
An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B
NCT00124241 ·Status: COMPLETED ·Phase: PHASE2
-
Adding Adefovir Dipivoxil Versus Switching to Entecavir in Patients With Lamivudine-resistant Chronic Hepatitis B
NCT00531167 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B
NCT00606099 ·Status: WITHDRAWN ·Phase: PHASE4
-
Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNA
NCT00625560 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy of Telbivudine With or Without add-on Tenofovir According to Roadmap Strategy Compare With Entecavir
NCT01588912 ·Status: UNKNOWN ·Phase: PHASE4
-
Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies
NCT00142298 ·Status: COMPLETED ·Phase: PHASE3
-
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
-
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
-
Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection
NCT01368497 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
NCT01026610 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone
NCT00376259 ·Status: TERMINATED ·Phase: PHASE3
-
Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy
NCT00409019 ·Status: WITHDRAWN ·Phase: PHASE4
-
Entecavir Plus Tenofovir Combination in Subjects With Multi-drug Resistant Chronic Hepatitis B Virus Infection
NCT01594905 ·Status: UNKNOWN ·Phase: PHASE4
-
Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B
NCT00131742 ·Status: COMPLETED ·Phase: PHASE3
-
A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection
NCT00393484 ·Status: COMPLETED ·Phase: PHASE4
-
Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable HBV DNA
NCT00625339 ·Status: COMPLETED ·Phase: PHASE4
-
Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable Hepatitis B Virus DNA
NCT00637663 ·Status: COMPLETED ·Phase: PHASE4