CLINICAL TRIALS PROFILE FOR TYZEKA
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All Clinical Trials for TYZEKA
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00640588 ↗ | Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine | Completed | Novartis Pharmaceuticals | Phase 3 | 2008-03-01 | This study will explore HBV kinetics in CHB patients during the first 24 weeks of treatment with telbivudine |
| 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 | Novartis | Phase 4 | 2008-03-01 | This study will explore efficacy and safety of Telbivudine in the fifth year of treatment. |
| NCT00651209 ↗ | 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 | Novartis Pharmaceuticals | Phase 4 | 2008-02-01 | This study will evaluate the use of telbivudine for patients with HBeAg-positive CHB with an option to intensify treatment at Week 24 by adding tenofovir for patients who do not achieve HBV DNA non-detectability. |
| NCT00710216 ↗ | Comparison of Telbivudine Versus Lamivudine on the Early Dynamics and Kinetics of Viral Suppression in Chronic Hepatitis B | Withdrawn | Novartis | Phase 4 | 1969-12-31 | This study examines the effect of telbivudine compared to lamivudine on the early viral kinetics in patients with chronic hepatitis B. The virus Kinetics is measured by the viral load (HBV-DNA) reduction in the serum during the first 12 weeks of therapy. |
| NCT00710216 ↗ | Comparison of Telbivudine Versus Lamivudine on the Early Dynamics and Kinetics of Viral Suppression in Chronic Hepatitis B | Withdrawn | University of Ulm | Phase 4 | 1969-12-31 | This study examines the effect of telbivudine compared to lamivudine on the early viral kinetics in patients with chronic hepatitis B. The virus Kinetics is measured by the viral load (HBV-DNA) reduction in the serum during the first 12 weeks of therapy. |
| NCT02049736 ↗ | Effect of Telbivudine on Renal Function and Proteinuria in Patients With CHB & Chronic Renal Diseases | Withdrawn | Chinese University of Hong Kong | N/A | 2013-12-01 | Chronic kidney disease (CKD) and chronic viral hepatitis due to hepatitis B virus (HBV) are both major public health problems. Treatment of chronic HBV infection in CKD patients, however, is not well defined because of insufficient data from clinical trials. Telbivudine is a new antiviral that provides effective and sustained viral suppression in patients with compensated chronic hepatitis B infection. Unlike other nucleotide and nucleoside analogues, renal toxicity is uncommon in telbivudine, and dosage adjustment is not required in patients with mild renal impairment. We propose to conduct an open-label single-arm study to evaluate the effect of telbivudine on renal function and proteinuria in patients with chronic HBV infection and mild-to-moderate renal impairment. Twenty patients with chronic HBV infection and chronic kidney disease (estimated glomerular filtration rate 15 to 60 ml/min) will be recruited. They will be treated with telbivudine, with the dosage adjusted according to thei renal function, for 5 years. Serum HBV DNA, proteinuria, renal function, and urinary inflammatory markers will be monitored. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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