drugset

drugset / Trial / 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

NCT00646503 ↗

Phase 4 Completed 150 enrolled Novartis

NaSingle-groupOpen-labelTreatment

Summary

This study will explore efficacy and safety of Telbivudine in the fifth year of treatment.

Timeline

Start: 2008-03
Primary completion: 2009-09
Completion: 2009-09

Publications

Results Hou JL, Xu D, Shi G, Wan M, Goodman Z, Tan D, Xie Q, Chen C, Wei L, Niu J, Wang Q, Ren H, Wang Y, Jia J, Bao W, Dong Y, Trylesinski A, Naoumov NV. Long-Term Telbivudine Treatment Results in Resolution of Liver Inflammation and Fibrosis in Patients with Chronic Hepatitis B. Adv Ther. 2015 Aug;32(8):727-41. doi: 10.1007/s12325-015-0232-2. Epub 2015 Sep 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Telbivudine	Small molecule	600 mg	Oral

Indications