MedPath

Telbivudine

Generic Name
Telbivudine
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

Renoprotective Effects of Telbivudine in Chronic Hepatitis B

Phase 4
Completed
Conditions
Hepatitis B, Chronic
Chronic Kidney Diseases
Interventions
First Posted Date
2018-12-19
Last Posted Date
2018-12-19
Lead Sponsor
The University of Hong Kong
Target Recruit Count
31
Registration Number
NCT03778567
Locations
🇭🇰

Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong, Hong Kong

The Safety of Anti-viral Therapy in Preventing HBV MTCT in Pregnant Women After Discontinuation

Phase 4
Completed
Conditions
Hepatitis B, Chronic
Interventions
First Posted Date
2018-03-19
Last Posted Date
2018-08-29
Lead Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Target Recruit Count
111
Registration Number
NCT03468907

Renal Function Improvement in HBsAg Positive Kidney Transplantation Patients Under Telbivudine Treatment.

Phase 4
Terminated
Conditions
HBsAg-positive Renal Allograft Recipients
Interventions
First Posted Date
2016-09-09
Last Posted Date
2016-09-09
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
19
Registration Number
NCT02894554

EFFORT Further Extension Study

Phase 4
Conditions
Hepatitis B, Chronic
Interventions
Other: off-treatment follow-up
First Posted Date
2016-07-07
Last Posted Date
2016-07-07
Lead Sponsor
Nanfang Hospital, Southern Medical University
Target Recruit Count
130
Registration Number
NCT02826070
Locations
🇨🇳

Beijing Ditan Hospital, Beijing, Beijing, China

🇨🇳

People's Hospital of Beijing University, Beijing, Beijing, China

🇨🇳

The Third Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China

and more 17 locations

Tenofovir Versus Tenofovir + Telbivudine for Chronic Hepatitis B

Phase 4
Conditions
Chronic Hepatitis B
Interventions
First Posted Date
2016-05-17
Last Posted Date
2019-03-18
Lead Sponsor
Seng Gee Lim
Target Recruit Count
146
Registration Number
NCT02774837
Locations
🇸🇬

National University Hospital, Singapore, Singapore

A Clinical Trial on Hepatitis B Vaccine Activated-Dendritic Cells Combined With Anti-HBV Drugs in CHB

Phase 1
Conditions
Chronic Hepatitis B
Interventions
Biological: HPDC-T cells & Entecavir
Drug: HPDC-T cells & IFN-a-2a
Drug: IFN-a-2a
Drug: HPDC-T cells & Telbivudine
First Posted Date
2015-11-26
Last Posted Date
2015-11-26
Lead Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Target Recruit Count
450
Registration Number
NCT02615639

Replacement of Lamivudine by Telbivudine to Improve Renal Function

Phase 2
Completed
Conditions
Virus Diseases
Disorder Related to Transplantation
Injury Due to Exposure to External Cause
Interventions
First Posted Date
2015-05-19
Last Posted Date
2017-02-07
Lead Sponsor
Chang Gung Memorial Hospital
Target Recruit Count
120
Registration Number
NCT02447705

The Effect of Anti-viral Drugs Used in Late Pregnancy on Long-term Development of Children

Conditions
the Safety of Anti-viral Drugs Used in Late Pregnancy
Interventions
First Posted Date
2014-11-26
Last Posted Date
2014-11-26
Lead Sponsor
Beijing Ditan Hospital
Target Recruit Count
400
Registration Number
NCT02301650

Efficacy of Antiviral Therapy in Pregnancy in Preventing Vertical Transmission of HBV in Mothers With a High Viral Load

Conditions
Immune Globulin, Prophylaxis, Telbuvidine, Vaccine
Interventions
First Posted Date
2014-10-01
Last Posted Date
2014-10-01
Lead Sponsor
Beijing Ditan Hospital
Target Recruit Count
600
Registration Number
NCT02253485

Study of Efficacy and Safety, Tolerability and Pharmacokinetics of Telbivudine in Children and Adolescents With Compensated Chronic Hepatitis B Virus Infection

Phase 3
Terminated
Conditions
Chronic Hepatitis B
Interventions
Drug: Placebo
First Posted Date
2014-02-07
Last Posted Date
2019-09-10
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
53
Registration Number
NCT02058108
Locations
🇺🇦

Novartis Investigative Site, Vinnytsia, Ukraine

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