67 Locations for Vertex Phase 3 up at clinicaltrials.gov

[foofighter]

Finally. A bunch of trial locations posted, the majority not yet recruiting. Nothing where I am, but Chicago is listed. Might be something there for others.

And Cedar Sinai was on the caller ID today when I got home. No message though. Hmmm.

Andiamo, when you did your trial were you commuting or did you relocate back to New York. For the whole trial, or part of the trial? LA would mean moving there, but I couldn't do it for the entire trial. I am wondering if I am nuts to think I can work this out (if I can get in).

Magnum you have tried to figure this out. Did the doc think you could swing it? What would you do if you got sick and couldn't get yourself to LA? Would the trial allow you an emergency room visit?

****. I wish they would just approve the darn stuff. Also, is it possible that it would be approved in Europe before the U.S.?  How does that work?

[redrodeo]

Here in San Antonio my Hep Doctor has started trials with pts who have relapsed using the new drug from Vertex. But for only geno 1a.. Which puts me in the rain if I relapse since I am 3a
Red

[toughluck]

Vertex should be having trials for naive and non responders, you already suffered once why make people wait. I hope I don't get the placebo.

[foofighter]

I found it. And to tell you the truth, when I read it, I was surprised that more people didn't comment. It seems there would be a ton of nonresponders that would be interested in this. Especially after Andiamo's FABULOUS news:

http://www.medhelp.org/posts/show/540421

In this thread from June 9 kespr posted this:

Phase 3 Study in Patients Who Failed Prior Treatment

Vertex and Tibotec plan to initiate a Phase 3 clinical trial in genotype 1 HCV patients who have failed prior treatment with peg-IFN and RBV in the third quarter, which will be led by Tibotec. The randomized, double-blind and placebo-controlled study will focus on regimens of 48 weeks total treatment duration, in which telaprevir is administered for 12 weeks, with a goal of maximizing SVR rates. The study is planned to be conducted at more than 50 centers in the U.S., E.U. and certain other countries.

Updates on the status of Vertex and Tibotec's clinical trials of telaprevir are available at www.clinicaltrials.gov.

[foofighter]

I can't figure this out...I know there is something starting up for nonresponders and I am pretty sure that it is not the Prove rollover thing.

I even think it was discussed recently in another thread which confirmed what the NP at my trial center told me a couple of months ago--that they will have a Vertex trial, but NOT for naives.

So another trial that is not listed at clinicaltrials.gov yet. Let me see if I can find the thread.

[Fl_Gator]

thank you...I go straight to shands now....it's a long drive for me alsoas well but I feel I am in the best care possible.

[somuchmore2]

Inclusion Criteria

"Has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C"

Well based on inclusion point above from the NCT00627926 file it looks like nothing is happening for all of us non-responders. Reckon back in 1998 or 2003 I err when going ahead with interferon/riba '98 and then peg-intergeron/riba '03.

However, good luck and best wishes for any of you who can receive vx950 now. Perhaps by 2011/12 the rest of us will have hope if these are the success of vx950 continues.......

[frijole]

Phase 3 is for treatment naive patients.  Here are the locations.

http://clinicaltrials.gov/ct2/show/NCT00627926?term=HEPATITIS+C&state1=NA%3AUS%3ATX&rank=30&show_locs=Y#locn

[FloridaMouse]

Hey Fla Gator,

I'm not sure where in Florida you are located ... but ...

I'm in Sebastian (Vero Beach area) and my local GI referred me to Shands when I relapsed.  Shands layed out my treatment plan and my local GI administers it and if any issues or questions come up my local doc calls my doc at Shands (Dr. David Nelson) and they work through the issue together.    They are working this way with me so I don't have to drive 3 hours up to Gainesville for doctor's appointments.

Mouse
P.S.  My local doc is excellent at finding answers to my questions ... I wish everyone had the benefit of a great doc like this.

[Fl_Gator]

when I was diagnosed, my GI poo-poo'd the experimental drugs as well. I specificly named VX-950 and he shrugged...like he'd never heard of it.

GI Dr not informed on cutting edge hep C drugs? WHAT? ...he told me that I didn't have to treat right away as my liver was stage 1 and did give me a referal to UF though. and I never went back to him...I went to Shands and talked to them about the new drugs. They were enthusiastic about the new research and I waited for them.  

When I ask a Dr questions...and he looks at me like a deer caught in the headlights...I have to go somewhere else....he's not going to help much...may as well ask the mail man or the check out girl at the 7-11

[toughluck]

A good way to put it is HERE COME THE PAIN.

[toughluck]

I go to my HCV clinic Friday for 2 hours of paperwork and demo { how to inject I guess } Vertex picked the hospital where my GI clinic is, I mentioned VX950 a year ago to my nurse practitioner she said never heard of it, when they talked to her about it she remembered my name and was told I am first on the list. I think first shot will be in 1 to 2 weeks. UMass Worcester I will keep you all posted, weird thing is I am overjoyed to to this, do I really know what I am getting into I hope so.