I was all set to start the trial for m13-099 had the interview had been cleared to start just needed a new liver biopsy last one was in 05. all set to go have it tomorrow. Got a call today from my contact at Virginia Mason and apparently I am ONE week over from test results I had in june 07. I finished up my last treatment 12/19/06 with labs done on 12/26/06 and I had cleared. had my 6 month on 6/22/07 the virus had returned. The time between those dates is 25 wks . The protocal for this abbot study is that the time between has to be 24 wks. I am at a loss for any rational thought on this...really one wk back in 2007. Study coordinator has a call into trial to see if any thing can be done, but she does not think it looks good,because studys have strict protocal to follow.
I would like to believe everthing happens for a reason...but right now I am so flippin' bummed. Just needing to vent.
Not sure I am so hopeful anymore.
Oh my thats unreal... You would think the most important thing to them would be that you had a PCR done at EOT last time and was clear. So no matter how you look at it you are a relapser. Either at 6 months or 6 months and 1 week, doesn't change a thing at this time.
I was in the last Boceprevir trial and yes they have very strict guidelines but there was also a little wiggle room here and there..... Hopefully your Study coordinator makes the right calls for you....... Good luck
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