Phase 1 study

[BJ1fish]

Has anyone out there participated in a phase 1 study. I have been offered a chance to join the PEG-RIL-29 study. This is one of the few studies for relapsers. I have treated 5 or 6 times, cleared only to relapse each time. Have tried intron A , peg-intron, Pegasys and  72 weeks of infergen and until 6 months ago have been on maintenance therapy. I was a stage 4 with a enlarged spleen. Last biopsy and mri came back a stage 3 and a normal size spleen. As I understand  the purpose of this study is to test how safe and how well this new medicine (PEG-rIL-29) fights the virus when it is given either by itself at different doses or in combination with the approved dose of
ribavirin. Even if it is working I would be taken off the drug at predetermined time. Other than a miracle cure what would be my benefits? I know this is a question for my doctor and I will ask her but until then I will be collecting my thoughts.  This is why I would like to talk to someone who has taken part of a phase 1 study. I was also told that there might be a  study with Telaprevir for relapsers coming up soon. This rumor is why I quite maintenance about 6 months ago. Most studies require that you be off of treatments for 6 months prior to the start of of the study. All my blood work has been in the normal range since I have stooped interferon , but I also know my liver was improving  while on treatments. I hate the unknown. Sorry to keep dragging this on just trying to get my thoughts together.

Thanks, Brian

[FlGuy]

Nice to see you again.  There are non-naive geno 1 (assume you are geno 1) people here (at least Andiamo and Susan 400) who have been in TVR trial already.  Andiamo worked out well, Susan was not so successful with TVR, but had no riba.  Andiamo had tx'ed about 7 time in the past too.  Seems to me that TVR is getting a little more 'established' even though it will not be ready for prime time until 2010 or so.  It's great that the tx's, and/or maintenance have given you a reprieve from progression somewhat.  Although not in your shoes, I think I'd focus on TVR whether it's now in trial or later when it's online.  Good luck in whatever you decide.

[DragonSlayer45]

I am in a phase 1 study right now for a polymerase inhibitor called R7128 . It is being given along with peg and riba as part of a triple therapy. Of course there is a chance (1 in 5) that I am getting a placebo. Even if I am I am still getting the peg and riba so I decided I wanted to participate in this trial. If you are a non responder you should look into the telaprevir  That is a phase 3 trial and has been having very good results. It also is given as a triple therapy. That appears to be the direction they are headed in, for now, that all of the new drugs are being given with peg and riba.

Obviously this is a decision you will have to make yourself and you will have to pass the screening process. Here is a link to the trial.

http://clinicaltrials.gov/ct2/show/NCT00703118?show_locs=Y#locn

Good luck