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Boceprevir Phase IV Trial in NYC
Hi, y'all! (That's my southern twang...south Brooklyn, to be exact.) I'm back in New York City for a few weeks and finally got in touch with the folks at Columbia Presbyterian Hospital about the Boceprevir Phase IV trial, which is designed to compare "Erythropoietin Use Versus Ribavirin Dose Reduction for Anemia". This is the trial that everyone here was goading me into volunteering for (with good reason), but which my strangely elevated hemoglobin seemed to rule me out of.
I figured what the heck, I'm here anyway so why not go over and check this place out. I met some pretty nice people at the Center For Liver Disease and Transplantation (although their primary focus is transplantation, not trying to avoid it). Schering-Plough has opened up the trial again, it appears, and maybe they are having trouble finding any Tx-naive chronic hep C. (Okay, I'm cynical. So what else is new?.) They did the ritual blood draw, the results of which I may or may not be told tomorrow.
I was told that if I am accepted - and my high hemoglobin is the only thing standing in the way - I will have to either give them my biopsy slides, which they will not return, or submit to another biopsy. Well, they ain't gonna grab my slides, so I guess they're gonna have to put the needle in. I don't care, after the bone marrow puncture in March I feel immune to biopsies. I'm even sorta interested to see how much liver they can get out this time, since the first one in 2008 only got 1.5cm, a pretty small specimen considering how much time the doc was in there probing around.
Actually, I'm counting on flubbing because of my hemoglobin. I don't fancy Tx in New York in the winter, taking subways up to 168th Street.
As I was leaving the Center I picked up a copy of Liver Connection, their patient newsletter. There's nothing in it about chronic hep C or Tx, just transplants. They do, however, run a series of "Educational Workshops" and I called the coordinating psychiatrist, Dr. Hafliger, to get some info on them. She told me that if I wasn't going to be transplanted it was a waste of time (from her tone of voice I think she meant her time, not mine). When I asked if the Center ran a hep C support group there was a pregnant silence on the line followed, finally, by a clipped "No!' and then the phone went dead. I thought of going by the workshop anyway to ask the good doctor if she'd ever been psychoanalyzed, but why look for trouble...
I'll be back in Tangotown soon, anyway.
Mike
I figured what the heck, I'm here anyway so why not go over and check this place out. I met some pretty nice people at the Center For Liver Disease and Transplantation (although their primary focus is transplantation, not trying to avoid it). Schering-Plough has opened up the trial again, it appears, and maybe they are having trouble finding any Tx-naive chronic hep C. (Okay, I'm cynical. So what else is new?.) They did the ritual blood draw, the results of which I may or may not be told tomorrow.
I was told that if I am accepted - and my high hemoglobin is the only thing standing in the way - I will have to either give them my biopsy slides, which they will not return, or submit to another biopsy. Well, they ain't gonna grab my slides, so I guess they're gonna have to put the needle in. I don't care, after the bone marrow puncture in March I feel immune to biopsies. I'm even sorta interested to see how much liver they can get out this time, since the first one in 2008 only got 1.5cm, a pretty small specimen considering how much time the doc was in there probing around.
Actually, I'm counting on flubbing because of my hemoglobin. I don't fancy Tx in New York in the winter, taking subways up to 168th Street.
As I was leaving the Center I picked up a copy of Liver Connection, their patient newsletter. There's nothing in it about chronic hep C or Tx, just transplants. They do, however, run a series of "Educational Workshops" and I called the coordinating psychiatrist, Dr. Hafliger, to get some info on them. She told me that if I wasn't going to be transplanted it was a waste of time (from her tone of voice I think she meant her time, not mine). When I asked if the Center ran a hep C support group there was a pregnant silence on the line followed, finally, by a clipped "No!' and then the phone went dead. I thought of going by the workshop anyway to ask the good doctor if she'd ever been psychoanalyzed, but why look for trouble...
I'll be back in Tangotown soon, anyway.
Mike
Also search the same site (clinicaltrials.gov) for telaprevir, the other protease inhibitor that is in final phase testing for approval. Telaprevir and boceprevir are very similar and looking to be equally effective. It would be good to be in a trial for either.
All of the boceprevir trials are at this site:
http://clinicaltrials.gov/ct2/results?term=boceprevir
Go through them according to which are recruiting.
The 6th one on the list is the one you are looking for. I was in the second, now I'm in the 5th. Looking at them all will give you an idea what they are using for inclusion and exclusion criteria. They usually do include compensated cirrhotics in phase 3 trials. They did in my trial.
http://clinicaltrials.gov/ct2/results?term=boceprevir
Go through them according to which are recruiting.
The 6th one on the list is the one you are looking for. I was in the second, now I'm in the 5th. Looking at them all will give you an idea what they are using for inclusion and exclusion criteria. They usually do include compensated cirrhotics in phase 3 trials. They did in my trial.
If you have the time please: Is this trial only for treatment naive patients? Are compensated cirrhotics excluded? I could not find the trial information. I live in Manhattan and the clock is tick tick ricking away for me. Thanks. d
Congrats on passing your trial screening! As for me, there's no point in my trying again as my hgb is always over 16.
Re the biopsy, there's nothing left of the liver fragment. It got used up making the first two sets of slides. That's 'cause they took out too little.
But don't let me get on that subject. I'm trying to keep my blood pressure down...[grin].
Mike
Re the biopsy, there's nothing left of the liver fragment. It got used up making the first two sets of slides. That's 'cause they took out too little.
But don't let me get on that subject. I'm trying to keep my blood pressure down...[grin].
Mike
From the conversation I had with the hospital that did my last biopsy, they can give them a piece of the non-dyed block as they call the piece of liver. They don't give them the whole thing.
They re-screened me monday because my hemoglobin was too high before (15.7). it was 14.7 from mondays results, so I am good to go. It's definitely worth trying again. I hope it works out for you-Dave
Hi Mike!
Sorry you didn't get into the trial. Hope you enjoy your ice skating, along with the 80° weather.
Sorry you didn't get into the trial. Hope you enjoy your ice skating, along with the 80° weather.
Just got the message from the hospital here: hemoglobin 16.9, and 15 is the upper cutoff for the trial. So, no Boceprevir for me, at least right now. It's just as well. Why interrupt a great skating run? I'm really on a roll at the rink. All that gym in Buenos Aires is paying off. And personally I think that sweating it out at the rink is better for my liver than their meds.
That trial would have been a problem any way you cut it. I've got no insurance here to pay for collateral damage from the meds, no one around to help me out if I got weak, and, worst of all, no cute Argentine girls to drag around the dance floor. I woulda got depressed for sure.
I tried, though. Now no one can say I didn't try. Take that, all you "treat or else"-ers out there!
Mike
That trial would have been a problem any way you cut it. I've got no insurance here to pay for collateral damage from the meds, no one around to help me out if I got weak, and, worst of all, no cute Argentine girls to drag around the dance floor. I woulda got depressed for sure.
I tried, though. Now no one can say I didn't try. Take that, all you "treat or else"-ers out there!
Mike
Congratulations on SVR! Now exercise, exercise, that's where it's at. I am ice skating in New York for a few weeks, then back to Buenos Aires for the winter tango scene. Gotta keep moving. twist and shake. Yeah!
M.
M.
Hi, Marcy! How's it going? How's the family? I was looking at all your photos, and I must say you've really got some lovely children and grandchildren. A beautiful family. And you are the cutest one of the bunch. (Don't tell the hubby I said so, though, okay?)
M.
M.
o yeh hows ya LFTs been l8ly mike?hope u r well m8 n i have been gettin back into exersise again just like u said....cos its just sooo gd for us n i feel gr8 n am losing weight n nearly look back to my slim old self.have u been dancing ur tango still etc?
hope all goes well mike....gd luck!!
hey mike i am cured now m8,i just thought id let u know,omg i still cant believe it,goty results last friday
.i just gotta convince my bf to go on tx as he thinks hep c if nothing as he is uneducated about it all just as i was a few yrs ago so i hope i can convince him to get it done,he doesnt even know wht strain he has yet n i would much rather him get rid of it now than when its too l8 cos the more damage ya have they say the harder it is to beat.
hey mike i am cured now m8,i just thought id let u know,omg i still cant believe it,goty results last friday
.i just gotta convince my bf to go on tx as he thinks hep c if nothing as he is uneducated about it all just as i was a few yrs ago so i hope i can convince him to get it done,he doesnt even know wht strain he has yet n i would much rather him get rid of it now than when its too l8 cos the more damage ya have they say the harder it is to beat.
I dunno, brother, I've got a big mouth, and if the pysc MD actually hasn't been analyzed she might become vindictive and dangerous. Who knows what she could pull? These big hospitals in New York remind me of my army induction center when they were trying to send my a$$ to Nam. It's easy to get in, but maybe not so easy to get out again.
Entertaining and informative as always Mike, thanks buddy!
If it were me, I'd go to the workshop :-)
If it were me, I'd go to the workshop :-)
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