Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B

Phase 3 Completed Novartis Novartis Pharmaceuticals · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved by the Food and Drug Administration (FDA) for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking adefovir dipivoxil.

Timeline

Start: 2004-11
Primary completion: 2006-08
Completion: 2006-08

Outcome

Met primary endpoint

paper At week 24, mean HBV DNA reduction was greater in group A than in pooled groups B and C (-6.30 vs. -4.97 log10 copies/mL; PMID 17909201 ↗

paper P < 0.001 PMID 17909201 ↗

Publications

Chan HL, Heathcote EJ, Marcellin P, Lai CL, Cho M, Moon YM, Chao YC, Myers RP, Minuk GY, Jeffers L, Sievert W, Bzowej N, Harb G, Kaiser R, Qiao XJ, Brown NA; 018 Study Group. Treatment of hepatitis B e antigen positive chronic hepatitis with telbivudine or adefovir: a randomized trial. Ann Intern Med. 2007 Dec 4;147(11):745-54. doi: 10.7326/0003-4819-147-11-200712040-00183. Epub 2007 Oct 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Adefovir dipivoxil	Small molecule	—	—
Subject	Telbivudine	Small molecule	—	—