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Avatar universal

Anybody doing the Boceprevir trials yet?

What are the results coming back on non-responders?  I saw my Dr. last week and they're starting the Vertex Prove 3s and Beceprevir trials for non-responders in the next few weeks.  

My platelets were 80 which may be too low for treatment.  Vertex are not allowing "rescue" drugs so my Dr. suggested the Boceprevir trial.  Don't know if I meet that protocol criteria though with the low platelets.  I should find out tomorrow.  

I wonder how Schering was able to get their drug through so fast compared to Vertex.  I guess Vertex being the smaller company has a lot more at stake if the trial fails whereas it would be the end of the world for SP.
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717272 tn?1277590780
Fascinating to read the back & forth of people excited about getting into the Boceprevir trial.  I started in the naive trial Nov. 14 and was lucky enough to randomize out after 28 weeks, on June 1.

Learned something interesting from my nurse at the 12 wk. followup visit.  They only had 15 of the 50 allowed at their site because Schering opened and closed enrollment so quickly.  She said it was only open for about 4 weeks around Thanksgiving.  I do remember that I wanted to wait another month before starting, to let my liver recover from alcohol and OTC's that did me so much damage, but she said they wanted to randomize all the patients very soon.   What I thought would be a second screening visit turned into shot day.

Guess we were all lucky to get in.  Also guess there will not be a sample size of 1080 like they anticipated.  Getting more interesting all the time.
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663420 tn?1248677385
On Page 15 of 21 pages says I get compensated up to $65 per visit for travel and parking expense. It's in the contract I have.
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408795 tn?1324935675
Yes, I had my ekg, chest xray and my bx yesterday.  I was told that I would hear something soon, after my results are reviewed.  I was told about the 65.00 but it don't say anything in my paperwork.  I gotta send out an email, more ppl are adding to this list.  More to share information with, cool.    
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Avatar universal
i was told i could get copies of bloodwork on request. also they let you know whats happening at each visit. just dont tell what arm you in, unless they ask you to stop for whatever reason. also you can drop out of the trial  for whatever reason. without question.
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Avatar universal
the compensation helps with traveling there and back. i have to go every 2 weeks . had no idea i would get paid 1200 dollars. its in mt contract. henry ford hospital even though i live close. doesnt matter. everyone gets 50 a visit, even for the screening.
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Avatar universal
i will be in naive tx starting nov.7 just got results from biopsy. stage one
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Avatar universal
Besides boceprevir trial theres also trials going on with telaprevir, both are showing great results. Just go to clinicaltrials.gov and put in HCV, and your state. brings up all the trials in your area. Good luck to you.

Keith, i'm also hoping to get in the boceprevir trial for relapsers, suppose to knoww soon. Best of luck to you.

Cando
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663420 tn?1248677385
I am applying for the Boceprevir Trial and I am located in the San Diego area.
You can check here for location sites
http://clinicaltrials.gov/ct2/show/NCT00708500?term=Boceprevir&rank=2&show_locs=Y#locn

Hopefully you can qualify for the Boceprevir trial treatment or I hope you have insurance.
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Avatar universal
Where are you applying for a trial and for what drug? I will go anywhere any time. My Hep C count just came back 7.4 mil. up from 2 months ago of 800,000.
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663420 tn?1248677385
I spoke to my research nurse today. I took the physical, EKG, Chest X-ray and blood work. I only need to do the renal eye exam. The nurse seems like they are ready to move on this pretty quickly. They offered to pay for my travel expenses but that is about it as far as payment goes. The drug company pays for all medical treatment. I am kind of wondering what happens if or after they decide to stop treatment for one reason or another. It looks like their are several people here that are about to start the same trial. I also hear that the trial is either closing or going to be a random trial and limit the amount of people in the trial. I am wishing all of us a successful treatment.
I am geno type1 with a viral load of 250,000. I am very health outside of the fact I have HepC. I am suffering from the side effects of the virus and it looks like I will have to suffer more with the treatment.
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Avatar universal
Haven't heard back from the research nurse yet.  I'll send her another email.  I'm not at all thrilled to start another study.  Just so disruptive to everything.   Like they say "whatcha gonna do though?"
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Avatar universal
Not sure on how the blood results will be given to us,but in my last trial i had a 4wk...8 wk...and 12 wk...and i recieved all copies of the results right in my hand after each visit.
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Avatar universal
I am go to go for my BOC first shot on Nov 7....its official...got the call from my nurse.
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358466 tn?1226240618
I just started a phase 3 trial for HCV genotype a naive in GA.

Had the blood, EKG, chest x-ray, and physical.

Scheduled for a liver biopsy and eye examination.

Meds to start soon after.

Nice there is a thread just for this.

Until again,
Lynn
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663420 tn?1248677385
I have recently been diagnosed with Hep C and will be starting the Boceprevir Trial in December 2008. I go for my test screening tomorrow. I am new to this forum but should be posting more frequently as time goes by. I may have questions for you people and will report my situation as it arises. I haven't spent a great deal of time here but it looks like everyone here is trying to help each other out with information to help get through this ordeal.
Thanks,
Keith
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408795 tn?1324935675
I rec'd a telephone call today and had my next week appointments confirmed, so that's positive news.  Was anyone else told that we will be told how our bloods are doing when we start in this study?  Also, will we just be told or will we be able to get copies as well?  later
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Avatar universal
Great news! So far you, me Stormrider are the naives that are 99% in. Virgocharm, are you naive?

Bill200 are you going back in for another draw? I have my start date scheduled but I know that the Schering rep is just coming back this Wed. Seems like there should be some final "official" notice that we are in fact "all systems go."

Wow. Enrollment closing fast. I screened on Sept. 29 and nurse told me I was number 10 (and I think she meant for the whole trial). Kind of a drag, because if you look at clinicaltrials.gov still not updated with all the locations. I guess you really can't count on using that as a tool to locate trial cities.
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408795 tn?1324935675
No, tx naive, first time thru and like everyone else, I'm hoping it only takes once.  
later
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Avatar universal
You in the relapser trial? Sounds good for you...

cando
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408795 tn?1324935675
My initial bloods looked good, I was told that much and also that I will get $65 dollars every blood appointment.  I was also told that it won't mention the money on the consent forms.  I still haven't had my appointment confirmed, and that's what I'm waiting to hear about.  Good luck  
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Avatar universal
Sounds right, the only thing is when your 12 week pcr results come back and if your not und then you will know you were in the placebo arm. At that time you will be able to continued with whats called the "provide" study where open-label boceprevir will be added to your soc for the remainder of 48 weeks........... Best to you

cando
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154668 tn?1290115995
I was scheduled to go for screening on the 21st, and a couple days ago I got a call to come in asap as they were about to close the enrollment.  I gave blood and had a ekg and signed the papers and will go back for an ultrasound, chest x-ray, and eye test.  

I asked when I will be getting viral load results and the coordinator said that I won’t be getting them until after the trial results are in.  Does this sound right to anyone?  

I asked about my chances of being selected and she they are pretty good as long as there are no surprises in the tests.  She said the start would be in the next 4 to 8 weeks and will get paid $45. per visit.

I tolerated pegasys rather well in my first 2 attempts and hope the pegintron will be as easy.
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Avatar universal
Thanks for the well wishes, much Appreciated.

cando
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Avatar universal
Hi there, screening went fine. Should know in a couple weeks if i make the cut. My only problem is what my platelet levels are. My gut says they will be to low.

AD's and sleep helpers are allowed, but not payed by the study. Rescue drugs will be paid by the study. Here they are paying 65.00 dollars per visit...... Best to you

cando
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