Prove3 inclusion/exclusion criteria

Eligibility
Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

    * Males and females between 18 and 70 years old
    * Detectable plasma HCV RNA > or = 10,000 IU/mL
    * Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of peginterferon with ribavirin
    * Can not also be infected with HIV (AIDS) or hepatitis B
    * Must be judged to be in general good health and able to receive Pegasys

[andiamo]

The original post was truncated:


Eligibility
Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

    * Males and females between 18 and 70 years old
    * Detectable plasma HCV RNA > or = 10,000 IU/mL
    * Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of peginterferon with ribavirin
    * Can not also be infected with HIV (AIDS) or hepatitis B
    * Must be judged to be in general good health and able to receive Pegasys

[willows]

The misleading slant of this information is the sheer numbers of folks who meet the criteria vs. the number of folks who will be in the trials.

There are about 20,000 non-responders from last year alone.  The trials will enroll about 1000.  The math is easy, Vertex can pick the very healthiest of us sick folks to make the tests look as good as possible.  That said, I hope they do.  Why would I, as a non-responder, make that statement?

The hoops a company has to jump thru for approval are incredible.  I want Vertex to do WHATEVER it takes to get teleprevir approved, for myself and all the rest of us.  So, while I may be cranky that I was turned down for a couple of trials, I balance the madness with a fervent prayer that Vertex gets the damnnnn drug to market quickly.  Just give me one little chance with it, I'm ready to rock and roll.

You have a day that is full of good stuff, other than Hep C.  I'm lookin at the snow outside and trying to line up the non-hep c related stuff I can do to make today a useful, productive day and maybe have some fun.  

I hate snow.

I hate Hep C worse.

Snowy Willow

[andiamo]

I hate snow and HepC as well.  I have been dealing with it for most of my life, but now I am hopeful that I will get rid of it.

I have called every medical center that I thought might participate in the trial and become a patient of the chief of GI at the most likely ones.  The research coordinators at the medical centers say that  Vertex is onloy using the inclusion/exclusion criteria published and the rest of the choices are up to the medical centers.

I am stage 3 - 4 transitional, 66 years old and have a high viral load.  I believe that I will be able to participate in the trial, so you should as well.

I hope it stops snowing and you get into one of the trials - dOn't give up.

[jmjm530]

I understand your concerns about "cherry picking" but I believe it's the local doctors running the studies and their medical teams, and not Vertex, who will be making the decisions of who will get in. So, if you technically meet all the requirements, I would think -- I would hope -- that any reasonable doctor would allow you into the study even if someone else might have "better" stats. You might even find a doctor who will err in your direction should you be on the fence with some criteria. I guess what I'm saying is as long as you somewhat fall into the criteria listed, do not give up trying. If not with one doctor, maybe with another -- and if not now, maybe in a little while.

All the best,


-- Jim

[APKhaos]

Cherry picking? Is this the January's conspiracy theory?

OK, so here's one data point. My initial conditions were geno1b, early stage 3 liver, with a VL of 28,400,000IU/ml , AST 80, ALT 124. Hardly the ripest cherry on the tree. In fact, the closest I've been to a ......but wait, I digress.

Of all the potential trial subjects in my area, there must be many who have a lower VL than 28 million, but I was selected first in our study group of around 11 total.

As others have said, its the local clinic that selects the subjects. AFAIK, the only selection criteria communication between the trial coordinators and the drug company is related to waivers for some marginal exclusion cases. No drug company is going to take the slightest risk of any suggestion that they manipulated the trial cohort.

Can you imagine how much money is at stake here? Forget about the market potential; the cost of the drugs, the labs, the trial group operations and the like add up to real money! They would not risk trashing the entire trial by doing something so openly observed and obviously stupid.

[ChrisDDD]

Hats off to all of you.  This is such a great group.  Thanks, Willow, for your wonderful post.  It's snowing here as well, but I happen to love snow!  I'm right with you guys.  Give me a chance.  Just PLEASE give me a chance!  Here's to all of us who wage this war every day of our lives.  Be well.

[Forseegood]

guess Jim's on a roll:) from what I believe, of course the co is looking at basic parameters and rules, but it's the study pro's in your particular study group who youre going to be dealing with (there is one in my area as well, and I've been in communication with them and know the study coordinator) and they might be able to make judgment considerations, etc, (as far as who is included) on their own, from what I understand, they do have some lattitude in this...

I know a women who was rejected last study, but was pretty adamament and peservered in getting into the study after all(maybe someone dropped out, whatever) sometimes plain old charm and perserverance will work when nothing else does:)...and of course, let;s also factor in that maybe most patients (of course, I have no way of knowing exact numbers on this, if anyone does) aren't studying these issues as much or in such a detailed way as the type of people who come on to these boards, etc...we're a pretty "hand's on" group....

[prettydamscared]

Hi, I'm a little confused. Have you already been turned down or are you anticipating this based on what your doctor is saying.  As I've said before, I can't imagine there was any cherry picking in our study or why whould they pick up Pam with an F3 liver and me and APK with 20M+ viral loads and APK with an F3 liver to boot.  Course that doesn't translate at all into what criteria they're using for Prove 3.

Just because I don't perceive that went on in our study doesn't translate into it's not going on in yours.  Nothing, and I mean nothing surprises me anymore.  But, do you know for a fact that you have been turned down at this point?

Anxiously awaiting to hear as I'm sure you are.

Char

[chcnme]

I don't think it's up to just the trial centers, doctors, or research coordinators to make decisions on all patients who are chosen (or not chosen.)  I wasn

[APKhaos]

chcnme said, "I wasn