Replies to post #1333 on Idenix Pharmaceuticals (IDIX)

[go seek]

decompensated liver failure
What is the present SoC?

IDIX must think Telbivudine could possibly be used in treatment given ongoing trial.

[DewDiligence]

Tyzeka Studies in Progress

[Includes but not limited to trials shown in
#msg-21238201. Studies sponsored by
NVS/IDIX. Also see #msg-22372270.]


First-line setting

Tyzeka vs Baraclude 12-week PK study in Korea
(40 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00412529
Open-label extension of above trial out to 2 years (recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00467545

Tyzeka vs Hepsera in e-positive patients
(120 patients, fully enrolled):
http://www.clinicaltrials.gov/ct/show/NCT00115245
Note: Data from first year reported in #msg-21746191 (scan halfway down).

3-arm trial in e-positive patients.
Arm A: Tyzeka + Pegasys
Arm B: Tyzeka monotherapy
Arm C: Pegasys monotherapy
(300 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00412750

Tyzeka +/- Valtorcitabine
(trial completed, data analysis underway):
http://www.clinicaltrials.gov/ct/show/NCT00128544


Second-line setting

3-arm trial in poor responders to Hepsera.
Arm A: Tyzeka + Hepsera
Arm B: Tyzeka + Viread
Arm C: Continued Hepsera monotherapy
(recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00409019

Hepsera +/- Tyzeka in Lamivudine-resistant patients
(60-120 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00376259

Tyzeka vs (continued) Lamivudine following first-line Lamivudine
(240 patients, fully enrolled):
http://www.clinicaltrials.gov/ct/show/NCT00132652


Miscellaneous settings

Tyzeka vs Lamivudine in decompensated liver failure
(240 patients, more than 50% enrolled):
http://www.clinicaltrials.gov/ct/show/NCT00076336