Telbivudine

Generic Name
Telbivudine
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C10H14N2O5
CAS Number
3424-98-4
Unique Ingredient Identifier
2OC4HKD3SF
Background

Telbivudine is a synthetic thymidine nucleoside analog with specific activity against the hepatitis B virus. Telbivudine is orally administered, with good tolerance, lack of toxicity and no dose-limiting side effects.

Indication

For the treatment of chronic hepatitis B in adult and adolescent patients ≥16 years of age with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Associated Conditions
Chronic Hepatitis B Infection
Associated Therapies
-
Clinical Trials
Related News

Comparison of Telbivudine Versus Lamivudine on the Early Dynamics and Kinetics of Viral Suppression in Chronic Hepatitis B

Phase 4
Withdrawn
Conditions
Hepatitis B, Chronic
Interventions
Drug: Lamivudine
Drug: Telbivudine
First Posted Date
2008-07-04
Last Posted Date
2009-04-20
Lead Sponsor
University of Ulm
Target Recruit Count
40
Registration Number
NCT00710216
Locations
🇩🇪

University Hospital Ulm, Ulm, Germany

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

Phase 4
Completed
Conditions
Hepatitis B, Chronic
Interventions
Drug: Telbivudine
First Posted Date
2008-03-28
Last Posted Date
2017-06-22
Lead Sponsor
Novartis
Target Recruit Count
150
Registration Number
NCT00646503
Locations
🇨🇳

Novartis Investigative Site, Beijing, China

Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine

Phase 3
Completed
Conditions
Hepatitis B, Chronic
Interventions
Drug: Telbivudine
Drug: oral adefovir
First Posted Date
2008-03-21
Last Posted Date
2017-03-28
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
30
Registration Number
NCT00640588
Locations
🇪🇸

Novartis Investigative Site, Barcelona, Spain

Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B

First Posted Date
2008-02-01
Last Posted Date
2012-05-02
Lead Sponsor
Novartis
Registration Number
NCT00606099
Locations
🇺🇸

Novartis, Sterling, Virginia, United States

To Evaluate Antiviral Efficacy of Telbivudine in Hepatitis B Antigen Positive (HbeAg-positive) Compensated Chronic Hepatitis B (CHB)

Phase 4
Completed
Conditions
Hepatitis B, Chronic
Interventions
Drug: Telbivudine
First Posted Date
2007-10-01
Last Posted Date
2017-06-23
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
100
Registration Number
NCT00537537
Locations
🇮🇳

Novartis Investigative Site, Vellore, India

An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B

Phase 4
Completed
Conditions
Chronic Hepatitis B
First Posted Date
2007-04-30
Last Posted Date
2017-06-23
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
44
Registration Number
NCT00467545
Locations
🇰🇷

Novartis Investigative Site , (405-760), In Cheon, Korea, Republic of

🇰🇷

Novartis Investigative Site , (420-717), Gyeonggi-Do, Korea, Republic of

🇰🇷

Novartis Investigative Site (705-035), Daegu, Korea, Republic of

and more 3 locations

Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B

First Posted Date
2006-12-18
Last Posted Date
2015-03-13
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
44
Registration Number
NCT00412529
Locations
🇰🇷

Yeungnam University Medical Center, Daegu, Korea, Republic of

🇰🇷

Gachon Univ. Gil Medical Center Hospital, Incheon, Korea, Republic of

🇰🇷

Asan Medical Center, Seoul, Korea, Republic of

and more 5 locations

Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy

First Posted Date
2006-12-08
Last Posted Date
2015-03-09
Lead Sponsor
Novartis Pharmaceuticals
Registration Number
NCT00409019

Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone

Phase 3
Terminated
Conditions
Hepatitis B
Interventions
Drug: telbivudine
Drug: adefovir dipivoxil
First Posted Date
2006-09-14
Last Posted Date
2011-06-30
Lead Sponsor
Novartis
Target Recruit Count
43
Registration Number
NCT00376259
Locations
🇺🇸

Novartis, San Diego, California, United States

🇨🇳

Novarits, Kaohsuing, Taiwan

Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B

Phase 3
Completed
Conditions
Chronic Hepatitis B
First Posted Date
2005-08-22
Last Posted Date
2017-02-23
Lead Sponsor
Novartis
Target Recruit Count
240
Registration Number
NCT00132652
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