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Vertex Prove 3 trial

Vertex response to my question about non-responder/relapser trial:

Thank you for writing to Vertex.  Vertex plans to initiate within a few weeks a study with telaprevir for patients with Genotype 1 HCV who have not responded to prior standard therapy for their disease.  The study is known as PROVE 3 and will involve clinical trial sites in the US, Canada and Europe.

Clinical trial sites that are able to accept self referred patients will be posted on www.clinicaltrials.gov with their contact information.  We expect that some sites may start the PROVE 3 in a few weeks, with the remaining sites to follow in early 2007.  As with most large clinical trials, the clinical trial sites will not open simultaneously, and thus we recommend that you frequently check www.clinicaltrials.gov for the most updated information as additional trial sites are added to this website as they are opened to enrollment.

We realize your interest in determining the location of clinical trial sites and when these sites may be running the trial.  Please continue to monitor the website listed above as new information on PROVE 3 is made available, as this is the best and most up to date source of information.


Please call Vertex clinical trials hotline at 617-444-6777 or email at clinical_trials***@**** with additional questions.
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Avatar universal
Thanks for your support, first of all.  I feel all but 99.99% positive that my hospital will be in this trial, since my doctor told me they will be and since his hospital and research team have participated in the VX trial for treatment-naive patients.  I've seen press releases stating that this hospital is not one of the nation's leaders in cutting-edge research and one of the first to get clinical trials, but THE nation's leader in cutting-edge research and the FIRST to get clinical trials.  Furthermore, VX is located in Cambridge, MA, right across the river from where this hospital is, as well as the honorable Dr. Nezam Ahfdal, my doctor.  I hope to hear from the research assistant next week.
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Avatar universal
A poster here has a list of all sites participating in the Prove 2 trial. His/her userid is cpscrs or something like that. Its highly likely that Prove 2 sites will also be involved in Prove 3.
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Avatar universal
Chris, I wish you well in your endevour and perhaps we will be able to exchange war stories in the near future. Being a Stage 4 who has had tx fail me already, this third leg of the trials appears to be one of the few tx options still available to me at this time.

Also, thanks for your insights mrmeet.  I do plan to follow the course of action you've suggested.  I've heard that the Mayo clinic down in Rochester being in the previous two legs (PROVE-1 and PROVE-2) and can hold hope that they will also be in this third leg.  I would find it hard to swallow that an international medical research/treatment center which is considered by many to be one of the top most centers in the world (at least evidenced by their many breakthroughs and visits from unnamed patients who reserve whole floors, or several floors, of local hotels in the city) would not be involved.  Fortunately, it is also a very commutable distance from me in the Twin Cities too.

So I guess it's time to start heating the phone lines to them to see if they are involved and about being accepted.  Fortunately, we are supposed to start getting more seasonal weather than we have been experiencing so far this winter with an Artic cold front about to plunge us down to the 0 Farenheit range of the thermometer, so I won't have to worry about the lines melting on me ;-)

It seems that another of the top medical centers here at the University of MN does not appear to be involved. So I'm praying that the Mayo is as the other alternative I've heard of in Chicago is a quite a bit further away (8 hour drive) and less attractive, but if it turns out that is the alternative, I most likely will go that route (no pun intended) too as I do not plan to simply roll over and throw in the towel (as my first tx doc put it) since that towel is my life, or at least the quality of it.

It certainly would be nice to achieve SVR and the peace of mind of not having to worry about every little scratch and cut possibly infecting my wife, children, or anyone else.  But it it turns out that it is something I may end up having to live with, I suppose that it could always be worse too.

Thanks again.
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Avatar universal
Hi GO.  This is a link (below) that has some interesting opinions and analysis  (and transcripts / earnings reports) from VRTX executives, Lynne H. Brum - Vice President, Strategic Communications;   Ian Smith - Chief Financial Officer;  John J. Alam - Chief Medical Officer; and Joshua S. Boger
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Avatar universal
I called the UM Miami site that ran the Prove 2 trial and they said that they had a large waiting list and only 20 openings.  They expect the Prove 3 trial to start enrolling the end of January and the treatment to start the beginning of March.

They also said the Schering will be conducting a trial of their new protease inhibitor and that they expect it to be as effective as VX  950.  I have no information on it.
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Avatar universal
I forgot to say that they indicated that some time muct elapse between the last treatment and the start of Prove 3 but didn't give me the exact time limit.  I believe the elapsed time from the last treatment is more important than the number of times in treatment.
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Avatar universal
In reading the latest press releases from Vertex the Prove3 trial for non-responders and relapsers will have 400 people total for the study group size. I was hoping for a must larger study group size. Phase 3 which I would think would have much larger study groups does not seem to appear on the radar screen as of yet.
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80575 tn?1207132364
How do you find if your center is being considered for the trial?  I've communicated many times with IU Medical Center and they have not given a direct answer.
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Avatar universal
I called the research coordinator at UM Miami.  I found an email address on their website and sent an email.  She responded immediately with her phone number.
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Avatar universal
I tried to contact Vertex on the trial and received a timely response which more or less said the same thing as the initial post to this thread.  One additional item of interest in their response which seemed to be missing from the initial post was the following, which BTW makes perfect sense and I thought I'd point it out to save Vertex from being bombarded with inquiries to which they do not have the answer:

"Vertex is not involved in the selection of subjects for clinical studies; this is up to the investigators at the clinical sites.  Vertex also cannot maintain a database of patients who are interested in this or future studies."


I only wish there was a central contact for these studies who could maintain a DB.  I would think there is a central organizing unit for the trial which establishes the criteria for how each site will conduct the study, otherwise it would seem to invalidate the study to have each site establish their own.  IMHO, it would certainly be more convienent for the patients if they also maintained a DB for interested parties and keep them in the loop on the progress of establishing and/or conducting the trial.  Then again, perhaps this is just my logical, scientific, engineering side attempting to make sense of it all.
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Avatar universal
I know we've discussed this before, but here we go again:

The drug company does have a central database, but the subjects that are in the trial are screened, selected, and submitted by the individual investigators who run each of the trial groups.

Think it is also true that the drug company does not have identity information such as full name, address etc on the subjects. Selected subjects are given coded numbers by their group investigator, and its this coded number that is used throughout the trial. Might have the detail twisted, but the general idea is there.

The drug company sets the selection criteria, but it can't play any part in screening or selecting the subjects.

Hope this helps with the clarified butter [maybe you had to be there?].
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170654 tn?1330079129
I also got an email from Vertex  -  DoMusic

Dear Mr. ******

Thank you for writing to Vertex. Vertex is currently evaluating VX-950 (telaprevir) in a global Phase 2b clinical development program.  Phase 2 is the second of three stages of development for a pharmaceutical product.

Vertex has not indicated a specific date when telaprevir is expected to reach the market, but is working as quickly and prudently as possible to bring telaprevir forward to patients.

Vertex has recently completed patient recruitment for two clinical trials with telaprevir, known as PROVE1 and PROVE2, for patients who have not had any prior treatment for Genotype 1 HCV.

The next trial with telaprevir will be PROVE3 for patients with Genotype 1 HCV who have not responded to prior standard therapy for their disease. Patient enrollment in PROVE3 is expected to commence shortly.  Vertex plans to conduct additional trials in other populations of HCV patients.

We suggest visiting our website (www.vrtx.com) for news on current and upcoming telaprevir trials as any new information will be posted there. Please also see www.clinicaltrials.gov to view specific clinical trials of telaprevir.

Please call Vertex clinical trials hotline at 617-444-6777 or email at clinical_trials***@**** with additional questions.  We are dedicated to providing you with the information that is most relevant and hope that this helps to clarify your questions.

Thank you for your interest in telaprevir and support in Vertex.

Best regards,

Clinical Development Staff
Vertex Pharmaceuticals Incorporated
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Avatar universal
Hey, I'm simply qouting and passing along the part of the response I got from Vertex.  Please do not shoot the messenger and I'm looking for a debate.

You obviously have more insight into them than I and I can only go with what they passed to me.

If you think they're pounding sand, then by all means send a message to the clinical_trials***@**** address in the original post to this thread as that's what I did to elicit the response I got from them.

If anyone else gets a different response or knows of a different means to get more information, then I for one am quite interested in learning of it, as I'm sure many others here would like to know as well.
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Avatar universal
No, nothing like that. Just wanted to explain the few things I've learned about how the subject selection and trial operation are run while preserving the double blind. It surely wasn't obvious to me for a while. Nothing more than that. Peace!
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Avatar universal
Thanks for the link.  I see there's a post from last week which contained the following statement, which I found interesting:

"VRTX is looking to become one of the rare success stories in a very tough industry, by launching a product with huge commercial potential against Hepatitis-C Virus, which currently does not have great treatment and is a large epidemic problem."

Do my eyes deceive me or did I see the words HCV and epidemic appear together, particularily by a writer?
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Avatar universal
I just saw this today and didn't see anything posted around December 13th, but Vertex issued a press release on that day stating that "Also in the next few weeks, Vertex expects to initiate PROVE 3, a clinical trial of telaprevir
that will enroll more than 400 treatment-experienced patients."

They also mention the rash problems (3% drop out rate) and UND rates after week 12 (88% VX-950 plus IFN and Ribavirin vs 52% for the placebo plus IFN and Ribavirin) (I believe that I've seen the 88%/52% numbers before but didn't notice to Prove 3 info).  You can find the entire release at:

http://www.vrtx.com/Pressreleases2006/pr121306.html
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Avatar universal
Isn't it interesting.  Yeah, they said it : )  I read for days from that site a few days ago, just consuming it until I felt like I had just had a crash course in VX. Granted, I know this is all "preliminary" and projections, but ...they HAVE assigned have a trade name for VX ("Telepravir")  and they HAVE begun manufacturing it in the ... (I forget what mg's pills) for commercialization for the treatment of the Hep C ("epidemic Hep C" at that)  


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Avatar universal
If you're really serious about participating in this trial, I can can offer you some advice based on my experience getting into the Prove 1 VX950 trial (which I'm presently enrolled in). First thing is to FORGET about the Vertex hotline or website. I used to rely on it (as it suggests) for the "latest information" on the (then) upcoming Prove 1 trial. But both the website and the hotline were very unhelpful in a practical sense. Had I relied solely on them, I almost certainly would NOT have gained access to the trial. I finally decided to contact the largest and most reputable research hospital in my area. A place I was almost certain would be likely to be participating in the VX trial. I then had to call several people within that big hospital trying to track down anyone who might know something about the trial. No real luck at first, mostly could only get indifferent/apathetic and poorly informed secretaries on the hook. Then I scheduled a follow up HCV checkup appointment with a doctor at that hospital, and inquired about the upcoming VX trial with him and the nurses while there. BINGO, he knew they were participating in the trial, and although he didn't have all the specifics, he kindly referred me to the name and number of a trial coordinator nurse in another department/division.

Afterwards I contacted her and FINALLY she confirmed their participation in the upcoming trial. She also told me that as long as I met the eligibility criteria (which I already knew I did), and came in for screening soon (which included a biopsy), she'd be able to get me in (or "randomized", as she put it). Meanwhile, Vertex's phone hotline and website were still providing the same generic/non-helpful BS stonewall form letter-isms about the trial. The best move I ever made was to simply use my wits and put some *persistent* amateur gumshoe-ing into it. I'd suggest you do the same - don't take no for an answer and stay at it! You'll get through and figure it out sooner or later. Just remember there's gonna be a lotta competition for this one, so I'd get on it TOUT DE SUITE.

Hope this helps a little, best of luck getting IN.
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Avatar universal
"Vertex is not involved in the selection of subjects for clinical studies; this is up to the investigators at the clinical sites. Vertex also cannot maintain a database of patients who are interested in this or future studies."

Thank you for posting this!  This is music to my ears.  If it's true, I feel relatively sure I'll get in, because my doc wants me in it, but he said the opposite of the statement you posted.  My doc said he wanted me in the Prove3, but that it was ultimately Vertex's decision.  Oh, I hope, I hope, I hope!  Take care.
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Avatar universal
Chris, I'm wishing you the best of luck!!  I hope you get in. Do indeed follow mre's suggestions, definitely!  They just did a press release this afternoon  (Vertex did)  on their Prove3.  Get in behind your case (I know you will) and if you have questions, come here and ask.  Very helpful folks here.  Many know the ropes very well!  
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Avatar universal
This non-responder/relapser Prove 3 trial will enroll something like double the number of subjects in the treatment-naive Prove 2 trial currently in progress. Have not seen the protocol yet to get a sense of the selection criteria. My center is enrolling now AFAIK.
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Avatar universal
THANK-YOU so much for this post.  It's been quite frustrating the last couple of months to get ahold of any information on this leg of the trial despite all the talk flying around about it.

For those interested, I have not been able to find any information on this at clinical trials website.  If anyone has any links I sure that it would be greatly appreciated if they could be passed along.
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Avatar universal
Glad you posted that!  Thanks!  Even in Canada!   OH YES!   (I get so excited over Vertex :)

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