Idenix Pharmaceuticals (IDIX)

[DewDiligence]

Baraclude Studies in Progress

[Studies sponsored by BMY except as noted.]


First-line setting

Baraclude vs Tyzeka 12-week PK study in Korea
(sponsored by NVS/IDIX, 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

Baraclude vs Hepsera
(52 patients, fully enrolled)
http://www.clinicaltrials.gov/ct/show/NCT00096785

Baraclude +/- Viread
(384 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00410072


Second-line setting

3-arm study in Lamivudine-refractory patients.
Arm A: Baraclude + Hepsera
Arm B: Baraclude monotherapy
Arm C: Hepsera monotherapy
(420 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00410202


Miscellaneous settings

Baraclude vs Hepsera in decompensated liver disease
(220 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00065507

Baraclude vs Viread/Truvada in decompensated liver disease.
Arm A: Viread
Arm B: Truvada
Arm C: Baraclude
(sponsored by GILD, 100 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00298363

Single–arm study of Baraclude monotherapy in patients receiving liver transplant
(70 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00395018

Single-arm study of Baraclude in first-line black/Hispanic patients
(80 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00371150

Long-term longitudinal study of Baraclude vs “physician’s choice” monotherapy
(12,500 patients, recruiting):
http://www.clinicaltrials.gov/ct/show/NCT00388674