Drugs / Telbivudine
last change May 2024 re-read 9 days ago

Telbivudine

also known as LdT · LDT600 · Sebivo · Tyzeka · 2'-deoxy-l-thymidine · LDT600A · NV-02B · Telbivudina · +1 more

Small molecule

Developed for
chronic hepatitis B virus infection · cirrhosis of liver · hepatitis B virus infection · chronic kidney disease · Hepadnaviridae infectious disease · hepatocellular carcinoma · disease arising from reactivation of latent virus
Investigated by
Novartis Pharmaceuticals · Novartis · Merck Sharp & Dohme LLC · Third Affiliated Hospital, Sun Yat-Sen University · Asan Medical Center · Beijing YouAn Hospital
+30 more · Chang Gung Memorial Hospital · Chinese University of Hong Kong · Fourth People's Hospital of Zhenjiang, China · Fudan University · Fuzhou General Hospital · Guangdong Provincial People's Hospital · Guangzhou 8th People's Hospital · Hua Zhang · Icahn School of Medicine at Mount Sinai · Lin Bingliang · Major Science and Technology Special Project of China Twelfth-Five-Year Project · Mayo Clinic · Nanfang Hospital, Southern Medical University · National Institute of Allergy and Infectious Diseases (NIAID) · National Medical Research Council (NMRC), Singapore · New Discovery LLC · Pusan National University Yangsan Hospital · Seng Gee Lim · Shao-quan Zhang · Singapore Clinical Research Institute · Southeast University, China · Sun Yat-sen University · Taixing People's Hospital · The Fifth People's Hospital of Suzhou · The First People's Hospital of Kunshan · The University of Hong Kong · University of Ulm · Wuxi Maternal and Child Health Hospital · Yi-Hua Zhou · Yonsei University

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) TYZEKA — 2009-01-23 – 2013-01-28 fda.gov ↗
Approved EU (EMA) Sebivo — 2007-04-24 europa.eu ↗
Approved US (FDA) TYZEKA — 2006-10-25 fda.gov ↗

Trials 47

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT00907894 Feb 2009 → Mar 2012 chronic hepatitis B virus infection Novartis Pharmaceuticals Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT02338674 Oct 2014 → Oct 2016 chronic hepatitis B virus infection Fuzhou General Hospital Completed No outcome recorded
Phase 22 trials
Phase 2 NCT00128544 May 2005 → May 2007 hepatitis B virus infection Novartis Completed No outcome recorded
Phase 2 NCT00124241 ? → Feb 2003 chronic hepatitis B virus infection Novartis Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT02447705 Jun 2013 → Dec 2016 Hepadnaviridae infectious disease, disease related to transplantation Chang Gung Memorial Hospital Completed No outcome recorded
Phase 315 trials · 3 met primary · 1 missed
Phase 3 NCT02058108 Oct 2014 → Jan 2019 chronic hepatitis B virus infection Novartis Pharmaceuticals Terminated Missed primary
Phase 3 NCT01595685 May 2012 → Dec 2014 chronic hepatitis B virus infection Asan Medical Center Completed No outcome recorded
Phase 3 NCT01270165 Jun 2010 → May 2012 chronic hepatitis B virus infection Yonsei University Unknown No outcome recorded
Phase 3 NCT00805675 Nov 2008 → Dec 2010 chronic hepatitis B virus infection Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT00640588 Mar 2008 → Dec 2009 chronic hepatitis B virus infection Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT00376259 Jan 2007 → Aug 2008 hepatitis B virus infection Novartis Terminated No outcome recorded
Phase 3 NCT00412750 Dec 2006 → Feb 2009 chronic hepatitis B virus infection Novartis Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT00412529 Dec 2006 → Feb 2008 chronic hepatitis B virus infection Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT00142298 Mar 2005 → Nov 2009 chronic hepatitis B virus infection Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT00132652 Feb 2005 → Dec 2006 chronic hepatitis B virus infection Novartis Completed No outcome recorded
Phase 425 trials
Phase 4 NCT02774837 Apr 2016 → Jul 2020 chronic hepatitis B virus infection Seng Gee Lim Unknown No outcome recorded
Phase 4 NCT03468907 Jun 2015 → Dec 2017 chronic hepatitis B virus infection Third Affiliated Hospital, Sun Yat-Sen University Completed No outcome recorded
Phase 4 NCT02826070 Apr 2015 → Oct 2016 chronic hepatitis B virus infection Nanfang Hospital, Southern Medical University Unknown No outcome recorded
Phase 4 NCT03778567 Aug 2013 → Jun 2016 chronic hepatitis B virus infection, chronic kidney disease The University of Hong Kong Completed No outcome recorded
Phase 4 NCT01799486 Feb 2013 cirrhosis of liver Lin Bingliang Unknown No outcome recorded
Phase 4 NCT01693679 Sep 2012 → Apr 2014 cirrhosis of liver Shao-quan Zhang Unknown No outcome recorded
Phase 4 NCT01588912 Apr 2012 → Dec 2013 chronic hepatitis B virus infection Pusan National University Yangsan Hospital Unknown No outcome recorded
Phase 4 NCT01637844 Apr 2012 → Oct 2014 hepatitis B virus infection Yi-Hua Zhou Completed No outcome recorded
Phase 4 NCT01380951 May 2011 → Dec 2012 chronic hepatitis B virus infection, cirrhosis of liver The Fifth People's Hospital of Suzhou Unknown No outcome recorded
Phase 4 NCT01379508 Mar 2011 → Dec 2015 chronic hepatitis B virus infection Novartis Pharmaceuticals Completed No outcome recorded
Phase not applicable2 trials
— NCT02049736 Dec 2013 → Jun 2015 chronic hepatitis B virus infection Chinese University of Hong Kong Withdrawn No outcome recorded Stop: Enrollment
— NCT00051090 — HIV infectious disease, hepatitis B virus infection National Institute of Allergy and Infectious Diseases (NIAID) Withdrawn No outcome recorded
Comparator or background therapy19 trials
Phase 1/2 NCT02615639 Comparator Nov 2015 → Nov 2018 chronic hepatitis B virus infection Third Affiliated Hospital, Sun Yat-Sen University Unknown No outcome recorded
Phase 1/2 NCT01718587 Comparator Nov 2012 → May 2013 cirrhosis of liver General Hospital of Chinese Armed Police Forces Unknown No outcome recorded
Phase 2 NCT03969017 Background Jun 2019 → May 2022 cirrhosis of liver Sun Yat-sen University Unknown No outcome recorded
Phase 2 NCT03491553 Background Apr 2018 → Mar 2019 chronic hepatitis B virus infection Gilead Sciences Completed No outcome recorded
Phase 2 NCT01943799 Background Sep 2013 → Sep 2014 chronic hepatitis B virus infection Gilead Sciences Completed Missed primary

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 72 sources stand behind the page.

FieldValueCited text
Known as Telbivudine “Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)” NCT01943799 ↗
64

“Nucleoside analogues (Lamivudine 100mg, Telbivudine 600mg, Entecavir 1mg, or Clevudine 30mg)” NCT01595633 ↗

“Maintaining LAM/LdT+ADV combination Lamivudine 100mg / Telbivudine 600mg +Adefovir 10mg” NCT01597934 ↗

“patients previously treated with telbivudine will be changed to entecavir” NCT03969017 ↗

“behalftelbivudine 600 mg per day (oral dose).” NCT01718587 ↗

“600 mg/day, oral telbivudine for 24 weeks” NCT00651209 ↗

“Telbivudine (Tyzeka®)” NCT03491553 ↗

NCT00646503 ↗

NCT02049736 ↗

NCT01380951 ↗

NCT00939068 ↗

Show 54 more sources

Known as 2'-deoxy-l-thymidine ChEMBL registry synonym — accepted as the source's own label CHEMBL374731 ↗
Known as LdT “This research study was conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by...” NCT00076336 ↗
15

“This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved...” NCT00115245 ↗

“AIM: To examine the efficacy of telbivudine (LdT) + adefovir (ADV) vs continuation of lamivudine (LAM) + ADV in patients with LAM-resistant chronic hepatitis B (CHB) who show a...” PMID 24431895 ↗ 2013

“Multicenter, Pilot Study of Telbivudine (LdT) Anti-HBV Treatment Prior to the Initiation of Highly Active Antiretroviral Therapy Containing Lamivudine in Subjects Coinfected...” NCT00051090 ↗

“Suboptimal responses to lamivudine or telbivudine plus adefovir (LAM/LdT+ADV) rescue therapy are common in patients with LAM-resistant hepatitis B virus (HBV) infections.” PMID 32460460 ↗ May 2020

“This study aimed to explore the efficacy and safety of tenofovir (TDF) and telbivudine (LdT) in this population.” NCT02338674 ↗

“One group received telbivudine (LDT, 600 mg/d), and the other group received lamivudine (LAM, 100 mg/d).” PMID 25071343 ↗ Jul 2014

“Early observational clinical data suggested that telbivudine (LdT) might have renoprotective effects.” NCT03778567 ↗

“600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.” NCT00376259 ↗

“All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD.” NCT00805675 ↗

“Telbivudine (LdT) 600 mg orally once a day for 104 weeks” NCT00412750 ↗

Show 5 more sources

Known as LDT600 “An Open-label, Multicenter, Randomized Study of Combination Therapy With Oral LDT600 (Telbivudine) Plus Adefovir Dipivoxil Versus Adefovir Dipivoxil Alone in HBeAg-positive...” NCT00376259 ↗
3

“Telbivudine (LDT600) 600 mg” NCT00467545 ↗

“LDT600 (Telbivudine)” NCT00907894 ↗

“telbivudine/LDT600” NCT00877149 ↗

Known as LDT600A “Telbivudine/LDT600A” NCT00862706 ↗
Known as NV-02B ChEMBL registry synonym — accepted as the source's own label CHEMBL374731 ↗
Known as Sebivo “Telbivudine (Sebivo®; Tyzeka®) is a synthetic nucleoside analogue that inhibits replication of HBV.” NCT02049736 ↗
1

NCT01083251 ↗

Known as Telbivudina ChEMBL registry synonym — accepted as the source's own label CHEMBL374731 ↗
Known as telbivudine (sevibo) “telbivudine (sevibo)” NCT01804387 ↗
Known as Tyzeka “Telbivudine (Sebivo®; Tyzeka®) is a synthetic nucleoside analogue that inhibits replication of HBV.” NCT02049736 ↗
1

“Telbivudine (Tyzeka®)” NCT03491553 ↗

Action Inhibit “Telbivudine is a thymidine analogue with excellent HBV inhibitory activity but no anti-HIV activity.” NCT00051090 ↗
Modality Small molecule “Telbivudine is a nucleoside analogue” PMID 23774433 ↗ Jun 2013
Route Oral “Administered orally” NCT00051090 ↗