| Tyzeka (telbivudine) / Novartis |
EVD, NCT00710216: Comparison of Telbivudine Versus Lamivudine on the Early Dynamics and Kinetics of Viral Suppression in Chronic Hepatitis B |
|
|
| Withdrawn | 4 | 40 | Europe | Lamivudine, Zeffix, Epivir, LAM, 134678-17-4, J05AF05, 73339, Telbivudine, Sebivo, Tyzeka, L-dT, 3424-98-4, J05AF11, 159269 | University of Ulm, Novartis | Hepatitis B, Chronic | | | | |
NCT00467545: An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B |
|
|
| Completed | 4 | 44 | RoW | telbivudine | Novartis Pharmaceuticals | Chronic Hepatitis B | 09/09 | 09/09 | | |
NCT00646503: 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 |
|
|
| Completed | 4 | 150 | RoW | Telbivudine, SEBIVO, TYZEKA | Novartis | Hepatitis B, Chronic | 09/09 | 09/09 | | |
ChiCTR-TRC-09000341: A 24-week, parallel-group, open-label, randomized trial comparing Telbivudine with Entecavir treatment in HBeAg-positive chronic hepatitis B patients |
|
|
| Completed | 4 | 124 | | received Telbivudine alone ;received Entecavir alone | The First Affiliated Hospital of Wenzhou Medical College; Level of the institution：, Self-finance | Chronic hepatitis B | | | | |
NCT00606099: Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B |
|
|
| Withdrawn | 4 | 0 | US | telbivudine, adefovir dipivoxil | Novartis | Chronic Hepatitis B | 11/09 | | | |
NCT01337791: Efficacy, Safety and Tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women With Elevated Alanine Aminotransferase Levels |
|
|
| Completed | 4 | 88 | RoW | Telbivudine treatment | Southeast University, China | Chronic Hepatitis B, Pregnancy Complications, High Viral Load, Elevated Alanine Aminotransferase Levels | 12/09 | 12/09 | | |
ChiCTR-TCC-09000420: A study on efficiacy and safety of telbivudine in interruption of intrauterine infection of hepatitis B virus |
|
|
| Completed | 4 | 200 | | no ;telbivudine 600mg/day, oral | The Nangjing Second Hospital Affiliated Southeast Medical University; Level of the institution：, Self-finance | Intrauterine infection 0f hepatitis B virus | | | | |
NCT00939068: Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission |
|
|
| Unknown status | 4 | 180 | NA | Telbivudine, telbivudine treatment, engineered HB vaccine, control group | Southeast University, China | Chronic Hepatitis B, Gestation | 07/10 | 11/10 | | |
| Completed | 4 | 2200 | RoW | Telbivudine | Novartis Pharmaceuticals | Chronic Hepatitis B | 09/10 | 09/10 | | |
ChiCTR-OCC-11001776: The efficacy of entecavir and telbivudine in HBeAg positive chronic hepatitis B patients with high viral load |
|
|
| Completed | 4 | 100 | | Telbivudine ;Entecavir | Center of infectious Diseases, West China Hospital of Sichuan University; Center of infectious Diseases, West China Hospital of Sichuan University, No | Chronic Hepatitis B | | | | |
NCT00409019: Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy |
|
|
| Withdrawn | 4 | 0 | US | Telbivudine, Adefovir, Tenofovir | Novartis Pharmaceuticals | Chronic Hepatitis B | 03/11 | | | |
NCT00877149: Efficacy of Telbivudine Treatment at Long Term on the Absence of Liver Inflammation in Patients With Compensated Chronic Hepatitis B |
|
|
| Completed | 4 | 80 | RoW | telbivudine/LDT600 | Novartis Pharmaceuticals | Compensated Chronic Hepatitis B | 04/11 | | | |
NCT00862706: Efficacy of Telbivudine in Blacks/African Americans and Hispanics/Latinos With Compensated Chronic Hepatitis B During 52 Weeks |
|
|
| Withdrawn | 4 | 0 | US | Telbivudine/LDT600A | Novartis Pharmaceuticals | Compensated Chronic Hepatitis B | 04/11 | 04/11 | | |
NCT00537537: To Evaluate Antiviral Efficacy of Telbivudine in Hepatitis B Antigen Positive (HbeAg-positive) Compensated Chronic Hepatitis B (CHB) |
|
|
| Completed | 4 | 100 | RoW | Telbivudine | Novartis Pharmaceuticals | Hepatitis B, Chronic | 06/11 | | | |
ChiCTR-ONRC-11001495: Lamivudine plus adefovir or telbivudine plus adefovir for chronic hepatitis B patients with suboptimal response to adefovir: a prospective controlled study |
|
|
| Completed | 4 | 80 | | Telbivudine 600 mg/day , Adefovir 10 mg/day ;Lamivudine 100 mg/day , Adefovir 10 mg/day | Center of Infctious Diseases, West China Hospital of Sichuan University; Center of Infctious Diseases, West China Hospital of Sichuan University, self-funding | Chronic hepatitis B | | | | |
NCT00651209 / 2007-004845-14: 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) |
|
|
| Completed | 4 | 105 | Europe, RoW | Tenofovir, Sebivo, Tyzeka, Viread | Novartis Pharmaceuticals | Hepatitis B, Chronic | 12/11 | | | |
TACEHBV, NCT01102335: Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using Transcatheter Arterial Chemoembolization (TACE) With Anti-hepatitis B Virus (Anti-HBV) Therapy |
|
|
| Unknown status | 4 | 80 | RoW | Transcatheter arterial chemoembolization (TACE), Telbivudine, Sebivo | Fudan University | Hepatocellular Carcinoma | 12/11 | 12/12 | | |
NCT00962533: EFFicacy Optimization Research of Telbivudine Therapy |
|
|
| Completed | 4 | 606 | RoW | telbivudine, Sebivo® | Nanfang Hospital of Southern Medical University, Major Science and Technology Special Project of China Eleventh Five-year, Novartis | Hepatitis B, Chronic | 04/12 | 08/12 | | |
NCT01788371: Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus |
|
|
| Completed | 4 | 700 | RoW | Telbivudine, Lamivudine | Hua Zhang, Icahn School of Medicine at Mount Sinai | Hepatitis B Infection, Chronic Infection, Viremia | 07/12 | 07/13 | | |
NCT00778596: Prednisolone Priming Study in Patients With Chronic Hepatitis B |
|
|
| Unknown status | 4 | 160 | RoW | Prednisolone, Placebo priming, Placebo | Yun-Fan Liaw, Chang Gung Memorial Hospital | Chronic Hepatitis B | 12/12 | 12/13 | | |
NCT01380951: Safety and Efficacy of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B (CHB) |
|
|
| Unknown status | 4 | 120 | RoW | telbivudine, Sebivo | The Fifth People's Hospital of Suzhou | Liver Cirrhosis, Chronic Hepatitis B | 12/12 | 12/13 | | |
NCT01743079: Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B |
|
|
| Completed | 4 | 700 | RoW | Telbivudine, LdT, Lamivudine, LAM | Beijing YouAn Hospital, New Discovery LLC | Chronic Hepatitis B, Late Pregnancy, Transmission, Complication | 07/13 | 07/13 | | |
TeSLA, NCT01804387: Comparison of Telbivudine Plus Adefovir With Lamivudine Plus Adefovir for the Treatment of Lamivudine-resistant Chronic Hepatitis B at 52 Weeks: A Pilot Study |
|
|
| Unknown status | 4 | 60 | RoW | telbivudine plus adefovir, telbivudine (sevibo), adefovir (hepsera), lamivudine plus adefovir, lamivudine (zeffix) | Korea University | Chronic Hepatitis B | 12/13 | 05/14 | | |
NCT01588912: Efficacy of Telbivudine With or Without add-on Tenofovir According to Roadmap Strategy Compare With Entecavir |
|
|
| Unknown status | 4 | 104 | RoW | Telbivudine, Sebivo, Tenofovir, Viread, Entecavir, Baraclude | Pusan National University Yangsan Hospital | Chronic Hepatitis B | 12/13 | 12/14 | | |
| Completed | 4 | 360 | RoW | Telbivudine, Adefovir dipivoxil, Sebivo, LDT | Third Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial People's Hospital, Guangzhou 8th People's Hospital | Hepatitis B, Chronic | 02/14 | 05/14 | | |
NCT01597934: Antiviral Efficacy of Switching to ETV Plus TDF |
|
|
| Unknown status | 4 | 104 | NA | Group A (Zeffix, Sebivo, Hepsera), Zeffix, Sebivo, Hepsera, Group B (Baraclude, Viread), Baraclude, Viread | Yonsei University, Bristol-Myers Squibb, Seoul St. Mary's Hospital, The Catholic University of Korea, Soonchunhyang University Hospital, Pusan National University Hospital, Kyungpook National University Hospital, Hallym University Medical Center, Chonbuk National University Hospital | Chronic Hepatitis B | 05/14 | 05/14 | | |
ACTRN12614001224617: A randomized controlled trial to study whether telbivudine can prevent virus reactivation and improve the prognosis after liver resection in patients with hepatitis B virus-related hepatocellular carcinoma |
|
|
| Active, not recruiting | 4 | 200 | | | ZHOU Wei-ping, The State Key Project on Infectious Diseases of China: 2012ZX10002010, 2012ZX10002016, Science Fund for Creative Research Groups, NSFC, China: 81201940, National Science Foundation of China: 81201555 | hepatitis B virus-related hepatocellulcar carcinoma | | | | |
SASL28, NCT01005238: Telbivudine Versus Lamivudine for Maintenance Therapy of Patients With Chronic Hepatitis B and Negative HBV Viral Load After 6 Month of Treatment With Telbivudine |
|
|
| Terminated | 4 | 27 | Europe | Lamivudine, Telbivudine | University Hospital, Basel, Switzerland | Hepatitis, Chronic | 12/14 | | | |
ChiCTR-OPC-16008318: Clinical study on the efficacy and safety of telbivudine for interrupting mother-to-child transmission of hepatitis B virus (HBV) in pregnant women |
|
|
| Completed | 4 | 77 | | LdT treatment (600 mg/day) from 28th. week of pregnancy until the delivery day, in case of confirmed CHB during pregnancy, they continued to use LdT after delivery according to the guideline of CHB treatment in China [22], and no breast-feeding during the LdT treatment. ;HBIG (200 IU dose once) was administered by intramuscular injection three times at the 28th., 32th., and 36th. gestational weeks. | the first Affiliated Hospital of Jinan University; the first Affiliated Hospital of Jinan University, Science and Technology Planning Project of Guangdong Province, China | chronic hepatitis B | | | | |
ChiCTR-OPC-16007899: Telbivudine to prevent mother-to-infant transmission of HBV in early and mid pregnancy |
|
|
| Completed | 4 | 188 | | treated with telbivudine from12 weeks of gestation，Telbivudine was discontinued at postpartum 12 weeks.; treated with telbivudine from20 to 28 weeks of gestation，Telbivudine was discontinued at postpartum 12 weeks. ;wasn’t given telbivudine treatment | Qingdao Chengyang People's Hospital; Qingdao Chengyang People’s Hospital, the Research Foundation of the Chengyang District | Chronic hepatitis B | | | | |
| Unknown status | 4 | 576 | RoW | telbivudine (ROADMAP), Telbivudine (Standard of Care) | Nanfang Hospital of Southern Medical University, Major Science and Technology Special Project of China Eleventh Five-year, Novartis | Hepatitis B, Chronic | 08/15 | 12/15 | | |
2010-022627-29: Innate immune responses in patients with chronic hepatitis B treated with Sebivo (telbivudine) |
|
|
| | 4 | 20 | Europe | SEBIVO*28CPR RIV 600MG, SEBIVO*28CPR RIV 600MG | OSPEDALE POLICLINICO S. MATTEO | Chronic HBV | | | | |
| Completed | 4 | 241 | Europe, RoW | telbivudine, LDT600, tenofovir disoproxil fumarate | Novartis Pharmaceuticals | Chronic Hepatitis B | 12/15 | 12/15 | | |
NCT03778567: Renoprotective Effects of Telbivudine in Chronic Hepatitis B |
|
|
| Completed | 4 | 31 | RoW | Telbivudine, lamivudine is switched to telbivudine | The University of Hong Kong | Hepatitis B, Chronic, Chronic Kidney Diseases | 06/16 | 05/18 | | |
| Unknown status | 4 | 130 | RoW | Telbivudine, Adefovir dipivoxil, off-treatment follow-up | Nanfang Hospital of Southern Medical University, Major Science and Technology Special Project of China Twelfth-Five-Year Project, Novartis | Hepatitis B, Chronic | 10/16 | 10/17 | | |
ChiCTR-TRC-13004454: Optimal options of antiviral programs in CKD combined with chronic hepatitis B immunosuppressive treatment patients. |
|
|
| Recruiting | 4 | 114 | | Telbivudine treatment ;entecavir | Nephrology Department, the First Affiliated Hospital, Third Military Medical University; the First Affiliated Hospital, Third Military Medical University, Clinical and scientific research special fund of Third Military Medical University | Chronic kidney disease combined with Chronic Hepatitis B infection | | | | |
NCT00810524: Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV Infection |
|
|
| Unknown status | 4 | 600 | RoW | lamivudine, Telbivudine, Enticavir, Adefovir Dipivoxil Tablets | Sun Yat-sen University | Hepatitis B, Chronic | 01/17 | 01/17 | | |
ChiCTR-OPC-16008331: Cohort study on Tenofovir and Telbivudine in preventing mother-to-infant transmission of hepatitis B virus in pregnant women with high viremia |
|
|
| Recruiting | 4 | 150 | | Tenofovir (300mg) was taken every day from 28th-32nd weeks of pregnancy to the delivery day ;Telbivudine (600mg) was taken every day from 28th-32nd weeks of pregnancy to the delivery day | the first Affiliated Hospital of Jinan University; the first Affiliated Hospital of Jinan University, Science and Technology Planning Project of Guangdong Province, China | chronic hepatitis B | | | | |
NCT03468907: The Safety of Anti-viral Therapy in Preventing HBV MTCT in Pregnant Women After Discontinuation |
|
|
| Completed | 4 | 111 | NA | Telbivudine 600mg, Sebivo, Tenofovir disoproxil fumarate 300mg, Viread | Third Affiliated Hospital, Sun Yat-Sen University | Hepatitis B, Chronic | 12/17 | 12/17 | | |
ChiCTR-OPN-17012206: Study on Tenofovir combination with Telbivudine in HBeAg positive Chronic Hepatitis B patients |
|
|
| Not yet recruiting | 4 | 100 | | Tenofovir 300mg 1 / day, combined with telbivudine 600mg 1 / day ;Tenofovir 300mg 1 / day | PLA 81th Hospital; PLA 81th Hospital, Foundation of Beijing Medical Health and Public Welfare | chronic hepatitis B | | | | |
NCT02774837: Tenofovir Versus Tenofovir + Telbivudine for Chronic Hepatitis B |
|
|
| Unknown status | 4 | 146 | RoW | Tenofovir disoproxil, Viread, Telbivudine, Sebivo | Seng Gee Lim, National Medical Research Council (NMRC), Singapore, Singapore Clinical Research Institute | Chronic Hepatitis B | 07/20 | 07/20 | | |
ChiCTR-OPC-16010157: Study on efficacy and safety of telbivudine combined with adefovir dipivoxil treatment of chronic hepatitis B patients |
|
|
| Recruiting | 4 | 200 | | DV 10mg +LdT 600mg QD ;DT 600mg +ADV 10mg QD ;ETV 0.5 mg QD | Tianjin 2nd People's Hospital; Tianjin 2nd People's Hospital, NA | Chronic hepatitis B | | | | |
ChiCTR2100048992: A prospective cohort study of potent and rapid inhibition of viral replication in the treatment of chronic hepatitis B |
|
|
| Not yet recruiting | 4 | 400 | | Tenofovir disoproxil fumarate ;Tenofovir alafenamide fumarate ;Tenofovir disoproxil fumarate combined Telbivudine ;Tenofovir fumarate combined with Telbivudine | The Third Affiliated Hospital of Sun Yat-sen University; The Third Affiliated Hospital of Sun Yat-sen University, Zhongguancun Precision Medicine Foundation | hepatitis B | | | | |
2006-004003-18: A randomized, open-label, controlled, mutli-center two-year study comparing efficacy and safety of telbivudine 600mg PO in combination with peg alpha-2a 180 µg with peg alpha-2a montherapy, and with telbivudine monotherapy in treatment naïve patients with HBeAg-positive chronic hepatitis B |
|
|
| | 3/4 | 40 | Europe | Telbivudine, LdT, LdT600, Pegasys, Pegasys | Novartis Pharma Services AG, NOVARTIS FARMA | Treatment of naïve patients with HBeAg-positive compensated chronic hepatitis B | | 02/09 | | |
