Update on VX-950 Non-Responders Trials

[Magnum]

Just received a call from Cedars-Sinai Medical Center in Los Angeles where one of the VX-950 trials will be held for non-responders. On my previous post, I stated that they require a biopsy before the start of the trial so that you can go to or near the front of the line. Apparently the assistant to Dr. Porodad was wrong. The other assistant told me it was not up to Dr. Porodad, but rather up to whoever is "sponsoring" the clinical trial (whatever that means).

At any rate, she said the non-responders roster will be filling up fast and there is no guarantee that if I get the placebo instead of the Teleprevir, that they will then give me the Teleprevir. However, I will be seeing the renowned hepatologist Dr. Gish from San Francisco here in Las Vegas on the 28th. His assistant says he has a lot of clout. So, keep your fingers crossed for me that I do NOT have to drive 14 round trips from Vegas to L.A. in the heat, the Ribavirin, Interferon, the vomiting, the nausea, the torture, pain, and anguish and agony. It's bad enough to sit still and be tortured, but to drive 600 miles round trip in 100+ weather.... such is the price for eventual glory?

Magnum

[foofighter]

Sorry folks, I am off thread topic here with Magnum posting about the non-responder Telaprevir trial, and my posts pertaining to the treatment-naive Vertex trial.

[foofighter]

Thanks for the info on the FDAAA of 2007. I read it and wonder at what point they have to post the info (just from people here, we know there are Boston, LA, Pennsylvania and Chicago locations, yet they are not listed).

I got a call from Cedars in LA on Thursday regarding this trial but I was a bit fuzzy having just returned from an endoscopy. I believe she said that each Advance trial center will only have 10 slots.

Seems like she was cleaning up her list so maybe they are getting close to "go" time. It will be interesting to see if they start popping up on Clinical Trials. I couldn't get her to understand that I would be willing to relocate and I didn't want to explain to her I had a fentynal/versed hangover and open that can of worms. I am gonna give them a call tomorrow and try again  : )

Hopefully there will be more info on other locations soon.

[kespr]

Just listened to a web cast at the Vertex website (April 21)and they talked about sending all their data from the 107 study and early data from the study of non responders,relapsers to the FDA to see what they want done in a prove 3 study. They said they would like to start the study by the 3rd quarter of 08. Thats why its not on Clinical Trials web site yet because they don't have instuctions from the FDA on what they want in their study. So far in all their Phases and Prove studies they have always given the placebo group that didn't get to SVR the vx 950 at a later time hence study 107

[Trish77]

FRM:  Trish:  I don't think that trials have to be conducted in Canada for the drug to get approval there. Most countries accept data from foreign clinical trials.
---------------------------------------------------------------------------------------------------
I'll have to check...that information came from a Hepatitis nurse who was giving a presentation and works out of one of our major treatment centres around here.  I had asked her about Infergen and she said it's not approved in Canada and they would love to get trials for that here.  I'd like to understand the process better as it helps to advocate more effectively for access to better drugs here in Canada, so I'll do that.

[FrontRangeMom]

I think the rep at Vertex may have been mistaken.  My understanding of recent legislation (called the FDAAA of 2007) is that companies in the US running a study under an IND will have to post it on clintrials.gov, not just if they are looking for volunteers.  The legislation was pretty complicated and I'm not clear on all of the provisions, but posting Clinical Trial information was a major portion of it.

Trish:  I don't think that trials have to be conducted in Canada for the drug to get approval there. Most countries accept data from foreign clinical trials.

"Mom"

[Andiamo1]

The prove 3 trial required a biopsy within three years of the date you start the treatment.  My doctor knew that to be the case a year before I started and advised me to do it immediately, so that I could start as soon as the trial was approved.

Many people here believe that the trial centers screen the patients to select the most likely to succeed with SVR.  That was not the case at my center and my doctor believes that is never the case.  Mt Sinai looks for people that will stick with the trial and honor the protocol.  I was probably the lease likely patient to SVR, given the number of prior failures, but they took me anyway.

[Trish77]

Thank you for this!! The one person in particular that I know, his doctor told him some years back after not responding to Rebetron that there was no point in him ever treating again as he only had a 10% chance of responding to drugs.  His doctor's advise basically was to give up and live with it!!  I had to hold back from saying too much because I can't impose my own way of dealing with things on other people.  So I'll fight that with information instead.  And he can assess for himself what works and what doesn't.  

I need to get to him quickly, foo.  If Toronto, then it has to be Toronto Western and I'll be there on Friday for my next appt in my own trial and I will ask if they're hosting this.    Gawd, I hope so.  

Magnum, thank you for the number.  I'll call that as well.  The other person I know is almost at his 24 weeks and is not responding.  He will likely not make it as I think you need to be off treatment for six months or so but I'll see how it goes.  

The exciting thing is that if they are trialling in Canada, the drug can be approved in Canada.  We don't have some of the drugs here that you do, such as Infergen.  So Infergen is not an option for these people.  

Thank you to both of you.  I can hardly stand it when people feel as if they have no hope.  In my own darker moments, it's that ray of hope I'm always reaching for.  Thanks again for the information.

Trish

[foofighter]

They are doing trials in at least 4 or 5 cities in Canada. I got the info from a cs at Vertex. He couldn't (for whatever reason) give me locations in the US but I remember he rattled off Winnipeg, Toronto and someplace in BC. I am spacing the other two.

He also explained that what you see posted on Clinical Trails will be locations that are taking self-referrers. If a trial site knows they will be able to fill up they don't have to post. I would imagine why advertise for something you don't need. They would just have people calling them. Everyone's advice here is to get on the phone. Thank god for the internet in finding phone numbers, docs and hospitals.

I have left messages at a bunch of places and actuallly got through to a human at Cedars in LA. An awesome human as a matter of fact. So nice, willing to chat and put me on his LONG, LONG, list after their current patients.

[Magnum]

I called Vertex 877-634-8789 and they told me about Cedars-Sinai's clinical trial. There is one also in San Francisco, Phoenix and I'm sure many more places...

Gaood luck,

Magnum

[Trish77]

I went on clinicaltrials dot gov and I didn't find this posted there.  I'm wondering if they're going to be doing any trials in Canada and hoping so.  I know a couple of non-responders and one of them is Stage 3/4.  Is this posted anywhere or is it basically go to the teaching hospital in your area and ask them about it?

Thanks and good luck to you in getting into this!

Trish

[FrontRangeMom]

The sponsor of the the trial is either Vertex or Tibotec.  It is typically the company that makes the drug and will ultimately be the entity applying to FDA or foreign authorities for marketing approval.  The clinical site has to abide by all the inclusion and exclusion critieria in the clinical protocol as this was vetted through the FDA or other authority before the trial can start.

"mom"