Phase II PI drug trial - comments?

[Trish77]

This is the drug trial I'm being screened for currently.  I will find out in two weeks.  If I get in, things will move VERY fast as last date for first dose is March 3rd and likely will be before that.  

I've seen others comment on how their own drug trials demanded some level of secrecy on the part of the participants so I asked about that .. and there are no demands of me in that regard.  

I'd be interested in any comments - positive, negative, "are ya nuts?" variety....doesn't matter.  Don't hold back now.  :)

http://clinicaltrials.gov/ct2/show/NCT00517439?term=hepatitis+toronto&rank=42

Thanks.

Trish

[jmjm530]

From Afdhal, above: hus, R1626 clearly had a significant bone marrow–suppressing adverse effect, with the incidence of grade 4 neutropenia ranging from 39% to 78%.
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Grade 4 would be ANC below 500, although how far below in percentage populations is not stated here but no doubt available. As Dr. J. states, low ANC does not seem to be the concern it once was, however "how low can you go" is the question. My docs allowed me to stay on full-dose Peg at ANC 320 without Neupogen and probably would not hv intervened unless it stayed around 300 for several weeks which it didn't and in fact rebounded by itself, which may not happen with this new drug. This also brings up the Neupogen issue and why -- if it isn't -- being used in the study as for example in an additional arm (make that 8 whew) where full dose Peg is used with Neupogen allowed, as opposed to an arm where full dose Peg is used without Neupogen.

Trish, from your point of view the variables seem not just the drug itself but what arm you end up in and how that arm turns out, esp if it turns out that full dose peg turns out to be necessary.

Certainly sound promising and folks just have to decide whether they want to get in at this early stage or perhaps wait until some of these questions are answered in the current trial.

-- Jim

[oneeagle]

I was in first trial at Mayo to establish inerferon/ribavarin therapy in 1995 - I would love to hear a synopsis of new approaches - I have been viral clear since my tx - but still am interested - and have fibrosis and other liver things to look at. My trial was 5 million units alpha interferon and trial amount of ribavarin. Riba daily and intrfrn every other day for a year. Have only lurked on this forum -mostly over on social addiction since I started doing too many narcs for comfort during therapy!!! Hang in there folks - I regret nothing about my choice and participation in trial.

[Lady Lauri]

Can't contribute much here, but the trial I am in I have never been told anything about 'secrecy', and someone pointed that out to me. I was never told a thing, so assuming not?

I was also in that 1st dose deadline, so was rushed in and luckily drew tha SOC, not the Albumin and thus far, there's problems with the dosing in it and serious lung issues with the albumin, their having to reduce, etc. As 2b tho, soc was good enough for me.

My opinion in trials is , unless time is a huge factor, damage is high, etc., to wait for phase 3 trials, as less risk, more info., stats, etc. It's a very unprofessional opinion tho!

Question: If one drew the short arm (wrong one they want) can they back out at that time and wait, or will it hurt them for future trials?

Once one has done a trial, didn't work, does it hurt their qualifications for next trials?

Figure it depends on each trial?

Good luck in your choice! I know your ready to go on this tx.

LL

[Trish77]

Thanks for this for a variety of reasons.  I had done a search looking for the list of articles presented at the AASLD 2007 because of one my NP referred to that I wanted to read and I couldn't find it for whatever reason.  Your link took me there.  I couldn't find the article relating to the topic she and I were discussing but I'm scanning and now I can go back later.

No congrats yet.  I'm in screening phase.  Still waiting to see if my long-ago HBV infection that cleared on it's own causes me grief.  I'm hoping not.  The study nurse didn't think so but we'll see.

I read the summary you posted.  This just simply adds to my sense that this is a good trial to be in and hoping I don't draw the short straw(s) but I'd rather take the chance than none at all.  Even the short straws on this one aren't too bad, seems to me.

[Trish77]

Jim,

Thanks for the links.  I've read and bookmarked them.  There are no teleprevir or boceprevir trials at the moment in this area, at least not according to clinicaltrials.gov.  There is one for teleprevir, however it's Phase II for non-responders to previous Teleprevir trials.  

The articles you posted actually make me feel a bit better about this.  I know 7 arms are alot of variables.  They seem to be studying multiple things with this one, one of which is SVR rates based on RVR for one of the arms.  

Incidentally, if I get in this trial, there is a sub-study taking place in conjunction with it that will study a variety of things and I'll be part of that too.  That's based more on various aspects of treatment and responses towards developing more appropriate treatment options.  I'll post specifics once I have the paperwork in front of me to do so clearly rather than from my feeble memory.  If I'm in the trial, I'm in the sub-study also.

[Trish77]

They told me it was doubleblind.  So perhaps I don't have my facts straight.  It IS doubleblind in that neither myself nor the trial sponsors will know which arm I'm in.

However, I WILL know the results of my quant PCR tests throughout the study.

Does this still mean doubleblind?