Idenix Pharmaceuticals (IDIX)

[go seek]

Tyzeka - Reference ongoing study commitments

http://www.centerwatch.com/patient/drugs/dru936.html

* Idenix has agreed to complete and submit the final study report for Study NV-02B-007, the 104-Week, Phase 3 registrational trial comparing the efficacy and safety of telbivudine to lamivudine in subjects with HBeAg-positive and HBeAg-negative chronic hepatitis B and compensated liver disease.
Protocol Submission: Study Ongoing
Final Report Submission: July 2007

* Idenix has agreed to conduct and submit a final study report to evaluate the use of LdT in the treatment of chronic HBV infection in minority racial/ethnic groups that were under-represented in the pivotal clinical trials (Blacks/African Americans, Hispanics).
Protocol Submission: June 2007
Final Report Submission: June 2010

* Idenix has agreed to conduct and submit a final study report for an efficacy and safety study of telbivudine in subjects who are co-infected with HIV and HBV. This study should include analysis of virologic, biochemical, and serologic endpoints for both HIV and HBV. It should also include evaluation of safety, and evaluation of HBV and HIV resistance.
Protocol Submission: June 2007
Final Report Submission: June 2010

* Idenix has agreed to complete and submit the final study report for Study NV-02B-011, the double-blind trial comparing the efficacy and safety of telbivudine to lamivudine in subjects with chronic hepatitis B and decompensated liver disease.
Protocol Submission: Study ongoing
Final Report Submission: April 2010

* Idenix has agreed to complete and submit the final study report for Study NV-02B-018, the open-label trial comparing the efficacy and safety of telbivudine to adefovir dipivoxil in subjects with HBeAg-positive compensated chronic hepatitis B.
Protocol Submission: Study ongoing
Final Report Submission: June 2007

* Idenix has agreed to complete and submit the final study report for Study NV-02B-022, the open-label, non-comparative trial assessing the long-term antiviral efficacy and safety of telbivudine in subjects with HBeAg-positive and HBeAg-negative compensated and decompensated chronic hepatitis B that have been previously treated in Idenix-sponsored telbivudine studies.
Protocol Submission: Study ongoing
Final Report Submission: May 2012

* Idenix has agreed to conduct and submit a final study report for a study evaluating CYP induction potential for telbivudine using in vitro or in vivo studies.
Protocol Submission: January 2007
Final Report Submission: January 2008

* Idenix has agreed to conduct and submit a final study report(s) for in vitro studies to evaluate if telbivudine is a P-gp inhibitor.
Protocol Submission: January 2007
Final Report Submission: January 2008

* Idenix has agreed to conduct and submit a final study report for a study to determine the anti-HBV cell culture combination activity relationships of telbivudine with entecavir.
Protocol Submission: December 2006
Final Report Submission: April 2007 (?)

* Idenix has agreed to conduct and submit a final study report for a study to determine the anti-HBV combination activity relationships of telbivudine in cell culture with the HIV NRTIs abacavir, emtricitabine, lamivudine, tenofovir, zalcitibine, and zidovudine.
Protocol Submission: February 2007
Final Report Submission: November 2007

* Idenix has agreed to conduct and submit a final study report for a study to determine the susceptibility to telbivudine and adefovir of the HBV rtA181 variants, rtA181T and rtA181S.
Protocol Submission: Study ongoing
Final Report Submission: November 2007

* Idenix has agreed to conduct and submit a final study report for a study to determine the susceptibility in cell culture of HBV harboring the following mutations of highly conserved amino acid residues among HBV isolates: R22C, W58G, L69P, L82M, P99L, L180M, L209V, T240I, I254F, P261L, G295E, A307V, L331F, or A342T. These amino acid substitutions were found in the viruses of patients who experienced virologic failure (serum HBV DNA levels =1,000 copies/mL at Week 52) to telbivudine therapy.
Protocol Submission: February 2007
Final Report Submission: February 2008 and December 2009

* Idenix has agreed to conduct and submit a final study report for a study to determine the mitochondrial toxicity of telbivudine in growing muscle cells, cell lines and primary cells, and primary hepatocytes with appropriate controls to validate the results.
Protocol Submission: March 2007
Final Report Submission: March 2008

* Idenix has agreed to complete and submit a final study report for ongoing genotypic and phenotypic analyses of HBV DNA from patients who experience virologic failure to long term telbivudine therapy (serum HBV DNA levels =1,000 copies/mL) in ongoing clinical trials.
Protocol Submission: Study ongoing
Final Report Submission: July 2007, July 2008 and July 2009