flosz schreef:
[quote=De "Prutser"]
Biolex laat lang op zich wachten met de resultaten van onderzoek fase 2b.
Die resultaten zouden ze bekend maken in het 4de kwartaal 2009? of is het 2010?
[/quote]
Locteron, which was co-developed by Biolex and Dutch drug delivery firm OctPlus, is expected to enter Phase III testing sometime next year, depending on the results of on-going Phase II trials.
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Phase 2b Study of Locteron Plus Ribavirin to Treat Hepatitis C Virus (HCV)
This study is currently recruiting participants.
The purpose of the study is to assess in subjects with chronic hepatitis C (treatment-naïve, genotype 1) receiving weight-based doses of ribavirin the virologic response to the 480 ug dose level of Locteron™, dosed every 2 weeks, in comparison with 1.5 ug/kg PEG-Intron™ dosed weekly.
Estimated Enrollment: 72
Study Start Date: July 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
clinicaltrials.gov/ct2/show/NCT00953589-----------------
Phase 2B Dose Ranging Study of Locteron Plus Ribavirin to Treat HCV (SELECT-2)
This study is ongoing, but not recruiting participants.
Estimated Enrollment: 100
Study Start Date: March 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
clinicaltrials.gov/ct2/show/NCT00863239