Approval Probability
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Also known as Telbivudine (LdT), Sebivo, Tyzeka, Hepsera, LDT600
telbivudine · 11 trials · 6 indications
Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA. Serum HBV DNA determinations were performed at a central laboratory through use of the COBAS TaqMan™ HBV DNA assay (Roche Molecular Systems, Pleasanton, CA, USA) which utilized the Real-time polymerase chain reaction (PCR) method and automated extraction by Cobas Ampliprep (threshold for detection 12 IU/mL). The Screening serum HBV DNA values must be ≥ 7 log10 copies/mL by COBAS TaqMan™ HBV DNA assay.
Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA.
The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA \< 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (\>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.
The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA \< 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (\>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.
The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA \< 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (\>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.
Maintained clinical response is defined as achievement of serum HBV DNA \< 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient's baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.
Maintained clinical response is defined as achievement of serum HBV DNA \< 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient's baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.
The primary efficacy endpoint for Group C patients was the percentage of patients with sustained therapeutic response (defined as HBV DNA \< 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is ALT within normal limits for a patient with an elevated ALT level (\>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.
The primary efficacy endpoint for Group C (other feeder studies) was the percentage of patients with sustained therapeutic response (defined as HBV DNA \< 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive study drug except in case of patients who relapsed and reinitiated treatment. No statistical summary was performed , only patient listing was generated.
Clinical response defined as achieving all of the following 3 criteria on at least 2 consecutive visits or at the last on-treatment visit: Serum hepatitis B virus (HBV) DNA \< 4 log10 copies/mL, normal Alanine transaminase (ALT) level (ALT ≤ Upper Limit of Normal (ULN)), and improvement (a 2- point or greater reduction in Child-Turcotte-Pugh (CTP) score) or stabilization (not more than a 1-point change in CTP score), compared to the baseline value. CTP scores range from 5-15, higher scores indicate more liver impairment. For Improvement/Stabilization, either of the individual criteria were met.
To evaluate the single-dose pharmacokinetics of LDT600 in pediatric and adolescent patients (2-18 years of age) with chronic hepatitis B (CHB) infection.
| Arm | Type | Description |
|---|---|---|
| Telbivudine 600 mg monotherapy | EXPERIMENTAL | All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. |
| Tenofovir disproxil fumarate 300 mg monotherapy | ACTIVE_COMPARATOR | All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. |
| Telbivudine 600 mg and Tenofovir 300 mg | ACTIVE_COMPARATOR | All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. |
| 1 | EXPERIMENTAL | Telbivudine |
| 2 | ACTIVE_COMPARATOR | Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks |
| Telbivudine | EXPERIMENTAL | - |
| Entecavir | ACTIVE_COMPARATOR | - |
| Telbivudine 600 mg | EXPERIMENTAL | Participants received Telbivudine 600 mg and a matching lamivudine placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 weeks post-treatment. |
| Lamivudine 100 mg | ACTIVE_COMPARATOR | Lamivudine 100 mg and a Telbivudine matching placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 weeks post-treatment. |
| Stratum 1 | EXPERIMENTAL | - |
| Stratum 2 | EXPERIMENTAL | - |
| Stratum 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Telbivudine | DRUG | 600 mg monotherapy supplied in film-coated tablets. |
| Tenofovir | DRUG | Tenofovir disoproxil fumarate was supplied in 300 mg tablets |
| Telbivudine plus tenofovir | DRUG | Telbivudine 600 mg and Tenofovir 300 mg were purchased in commercial packs. Patients were instructed to take medication(s) orally every morning either with or without food. |
| oral adefovir | DRUG | Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks |
| Entecavir | DRUG | Entecavir 0.5 mg once daily for 12 weeks. |
| Telbivudine (LdT) | DRUG | Telbivudine was to be supplied as white to off-white, oval, bi-convex tablets for the 200 mg tablets and white to off-white ovaloid, slightly curved, beveled edges, film coated tablets for the 600 mg tablets. Study drug (600 mg) was to be self-administered by patients orally (p.o.) in a once daily regimen for 104 weeks; for study consistency, the daily dose had to be taken at the same time each day, with or without food. |
| Lamivudine | DRUG | - |
| Adefovir Dipivoxil | DRUG | - |
| Placebo | DRUG | Telbivudine matching placebo or lamivudine matching placebo tablet. |
| valtorcitabine | DRUG | - |
| LDT600 (Telbivudine) | DRUG | LDT600 (Telbivudine) |
Inclusion Criteria: * Chronic HBV infection, defined as positive serum HBsAg for at least 6 months, or HBsAg positive \> 3 months and negative for IgM anti-HBc and positive for IgG anti-HBc * Age \< 40 years old * HBeAg positive * HBV DNA \> or = to 10\^7 copies/mL by Abbott real-time PCR * ALT \< ...
Telbivudine is used for the treatment of chronic hepatitis B, including hepatitis B virus infection. It is an antiviral small molecule developed for this infectious disease indication. Clinical studies of telbivudine have enrolled adults with chronic hepatitis B and hepatitis B virus across multiple countries.
Telbivudine is developed by Novartis AG, which trades under the ticker NVS. The drug has also been studied in Idenix-sponsored telbivudine trials, and Novartis is the company associated with its development program in chronic hepatitis B.
Telbivudine is in Phase 3 clinical development. Five Phase 3 trials have been completed, with no active trials currently listed. The completed studies together enrolled 2,139 participants and evaluated telbivudine in chronic hepatitis B and hepatitis B virus.
Completed Phase 3 trials of telbivudine include NCT00805675, which compared telbivudine and tenofovir disoproxil fumarate on hepatitis B virus DNA kinetics in China, NCT00640588 in Spain, NCT00412529 comparing telbivudine and entecavir in South Korea, and NCT00142298, a long-term study across many countries.
Yes, telbivudine is also known as LdT. Telbivudine (LdT) refers to the same antiviral small molecule studied in chronic hepatitis B and hepatitis B virus. Readers searching for LdT will find the same drug and clinical development program as telbivudine.
The telbivudine Phase 3 trials were randomized, double-blind, and active-controlled, with no biomarker selection. They enrolled adults with chronic hepatitis B or hepatitis B virus, including a large study, NCT00142298, that enrolled 1,869 participants previously treated in Idenix-sponsored telbivudine studies.