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956931 tn?1271636169

Trial Study

Just wondering if anyone has started the Boceprevir trial study anywhere? I have been accepted into this study and am curious what the feedback is from anyone who has already begun. Still pretty new to the forum but have paid close attention to the wisdom of you who have been on here for some time. I am impressed with several of you for the vast amount of knowledge you have acquired regarding all phases of this virus and its tx's. Thank you for your willingness to share and to teach. :)
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720656 tn?1311040235
Sending good thoughts your way for Tuesday's screening.
You should know shortly thereafter if you are accepted into the trial.
I will be watching for good news!
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956931 tn?1271636169
Thank you. I will add an update after Tuesday's preliminary work is done.
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Avatar universal
I called a couple of weeks ago to the admin on this trial. It says that it is still recruiting and they they added more locations a week ago, but they tell me it is closed. good luck with it, hope you clear it positude! - Dave
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717272 tn?1277590780
It is lucky to get into the boceprevir/epo trial.  Treat for free and carefully monitored, get triple ************** ahead of the release of the drug next year.  

NYG, they provided procrit to the previous boceprevir trial patients.  I think the purpose of this study is just to make the drug look better for marketing purposes when it has to go head to head with the other PI, Teleprevir.  They both drop hemoglobin levels but if Boceprevir can provide a study that can get the FDA to approve procrit to use with it, they will be ahead in the label game.  Some doctors balk at using procrit since it is an off-label use, insisting on reducing the riba instead to control low hemoglobin.  I think the study is a pretty good idea.  
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956931 tn?1271636169
Thank you very kindly. I feel very blessed to be part of this forum and have such wonderful people here willing to offer any and all help possible. I'm sure that there are many others who, like me, come to this forum and just read quietly and try to absorb the wealth of information available here. To them, I encourage you to "read on"! But should you have a question that you do not see addressed here, don't hesitate to ask. You will find a greater outpouring of knowledge and experience here than is available anywhere else that I know of. I applaud you all.

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956931 tn?1271636169
P.S.

Let me just add that I pray for EVERYONE to be cleared of this nightmarish virus.
Best wishes to all.
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179856 tn?1333547362
PS Love your name positude! :)
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179856 tn?1333547362
Rocker is right about this Boce does rock.  In fact I can't remember anyone who got it actually not succeeding?

The idea that this is an epo study is very very intriguingly wonderful.  Of course it will be interesting to see what happens with less of the meds on board - less meds is always better - but the idea that they will let people take epo rather than dose reduce too is so great.......why suffer or take risks of failure when you don't have to! I have not heard of telepravir doing this yet does anyone know if they have?  it seems Boce is making GREAT strides these days. Miracle drug it is for sure. I wonder if it will beat Tele to market? Whichever one does is going to make a mint.

GREAT luck to you and welcome to the forum! Can't wait to see you succeed!

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956931 tn?1271636169
Hello and thanks again to all responders.

I so appreciate the comments, and all the wisdom and encouragement! :) I can tell that this forum will be my refuge when things get tough.

@Vic; That makes perfect sense and is something I probably should have known from all the months I've been reading comments on this forum, but didn't. You made it very easy to understand, and I thank you for that explanation.

@Gee704; Thank you. It is so nice to know that I am not alone in all of this. I was hoping to find someone with whom I could "share the ride", so to speak, and perhaps we can be a source of strength and encouragement to each other. I am very happy for you as well and pray that we both will be cleared by the treatment. Please keep in close contact with me. I go next Tuesday for my EKG and CXR and some blood work, so don't know when exactly my study starts, but will certainly let you know as soon as I do. And I suppose there is a chance that I could be excluded for one reason or another, I'm not certain. But I will post updates. In the meantime, I am sending good thoughts your way. :)

@Rocker; I have been told that this study is coveted by many because of the opportunity to receive the Boceprevir, and I do indeed feel very fortunate to be getting this opportunity. And on a personal note, I am thankful to my Creator daily for all the blessings that are poured upon me. Thank you for saying it that way. :)

It is nice to make new friends. You are all very appreciated.
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Avatar universal
You are very lucky to get in thr B0C trial...thank your creator.
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720656 tn?1311040235
Hello Positude!

I am the one newleaf speaks of in the Boceprevir trial. I am through all the screening and I am looking forward to getting the show on the road. Initially I was going to begin treatment yesterday but decided to put off until next Friday so the timing of my shots would coordinate with work and study appointments better.

The "arms" in this study are designed to research anemia. I believe Arm 1 will dose reduce ribavirin and Arm 2 will use the "epo" (Procrit). That is the beauty of this study - we are guaranteed to receive all study drugs.

Here is the link to the trial:
http://www.clinicaltrials.gov/ct2/show/NCT01023035?term=chc&recr=Open&rcv_s=11%2F18%2F2009&rank=1

Welcome to the forum! I am certain we will be in close contact and can help each other through the next year.

There is insurmountable help here. Everyone is so knowledgeable and helpful. I feel as if I have my masters and am working toward my doctorate.
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Avatar universal
A study arm or treatment arm is a group of persons in a study who receive the same treatment.  For example, my study has 7 arms.  The first arm will receive 100 mg of the study drug for 12 weeks and a placebo for the remaining 36 weeks.  The second arm will receive 150 mg of the study drug for 12 weeks and a placebo for the rest, and so on.  Each arm is different.  Neither I nor the doctors or nurses conducting the study know which arm I am in.  Only the drug company knows.  I won't find out until the end of the study.  

Vik
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956931 tn?1271636169
Thanks for the comments! I have not actually begun the meds, but go in next week for preliminaries and should know more after that as to when they will start.

@Vik; I'm sorry to sound so naive, but I have no idea what is meant by "arms". However, I will be asking as it sounds important, thank you.

I do know that the study is actually an "epo" study. Everyone gets all 3 drugs (the Pegylated Interferon, the Ribavirin, and the Boceprevir) and half will get Epogen when the anemia hits, the others will get a reduction in meds. Fine tuning the Boceprevir.

I am genotype 1a, which is among the top most difficult to treat if I correctly understand, and so am excited to begin tx with the new drug. I do however feel apprehension, as I know all of you have, at the prospect of facing the sometimes horrible side fx. Understandable.

Again, thank you for the comments. I will keep watching the forum for advice and knowledge and will post back when I have more information with hopes that others may offer more comments with their experiences.

Congratulations to all who are SVR.  
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Avatar universal
BOC rocks.I did a trial and im over the 6 month SVR date.
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717272 tn?1277590780
I know of one other on this forum who was accepted but don't think they have started yet.  Be sure and ask again a week or two after you start the Boceprevir (follows 4 weeks of peg/riba lead-in).  I think you will find some others then and will find their side effects very interesting.
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Avatar universal
Congratulations on being accepted in  the Boceprevir study!  I recently started in a study of TMC435, which is also a protease inhibitor.  I am now in my 10th week of 48 weeks.  How many arms does your study have?  Mine has 7 arms, 6 arms are SOC + TMC435 and the 7th arm is SOC + placebo, so I have a 1 in 7 chance of getting the placebo.  My sx have been mild so far, but it's still early yet.

Vik
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