Telbivudine
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 19 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 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 24 trials | ||||||
| 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 | No outcome recorded |
| Phase 2 | NCT00804622 Comparator | Dec 2008 → Jun 2009 | chronic hepatitis B virus infection | The University of Hong Kong | Completed | No outcome recorded |
| Phase 49 trials | ||||||
| Phase 4 | NCT02894554 Comparator | Jul → Oct 2014 | — | National Taiwan University Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT01597934 Comparator | Aug 2012 → May 2014 | chronic hepatitis B virus infection | Yonsei University | Unknown | No outcome recorded |
| Phase 4 | NCT01595633 Background | Mar 2012 → Feb 2014 | chronic hepatitis B virus infection | Yonsei University | Unknown | No outcome recorded |
| Phase 4 | NCT01529255 Comparator | Aug 2011 → Aug 2015 | chronic hepatitis B virus infection | Nanfang Hospital, Southern Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT01804387 Comparator | May 2011 → Dec 2013 | chronic hepatitis B virus infection | Korea University | Unknown | No outcome recorded |
| Phase 4 | NCT01005238 Comparator | Sep 2009 → Dec 2014 | chronic hepatitis B virus infection | University Hospital, Basel, Switzerland | Terminated | No outcome recorded |
| Phase 4 | NCT00962533 Comparator | Aug 2009 → Apr 2012 | chronic hepatitis B virus infection | Nanfang Hospital, Southern Medical University | Completed | No outcome recorded |
| Phase 4 | NCT01337791 Comparator | Aug 2008 → Dec 2009 | chronic hepatitis B virus infection, pregnancy disorder | Southeast University, China | Completed | No outcome recorded |
| Phase 4 | NCT00537537 Comparator | Aug 2007 → Jun 2011 | chronic hepatitis B virus infection | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT01732224 Comparator | Nov 2012 → Apr 2014 | disease arising from reactivation of latent virus | Institute of Liver and Biliary Sciences, India | Completed | No outcome recorded |
| — | NCT01260610 Comparator | Jun 2011 | chronic hepatitis B virus infection | Institute of Liver and Biliary Sciences, India | Withdrawn | No outcome recorded |
| — | NCT01083251 Comparator | Mar 2010 → Feb 2012 | chronic hepatitis B virus infection | Ziv Hospital | Unknown | No outcome recorded |
| — | NCT01480492 Comparator | Jan 2010 → Oct 2011 | chronic hepatitis B virus infection | Cz Li | Completed | No outcome recorded |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 72 sources stand behind the page.
| Field | Value | Cited 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 ↗ |
| 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 ↗ “Telbivudine(LdT)-based optimization strategy” PMID 33287722 ↗ Dec 2020 “LdT (Telbivudine) and lamivudine” NCT00275652 ↗ “Telbivudine (LdT)” NCT00128544 ↗ “Telbivudine (LdT)” NCT00142298 ↗ “LdT (Telbivudine)” NCT00057265 ↗ |
| 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 ↗ |
| 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 ↗ |