has anyone heard of this trial

Im in los angeles, geno 1a F2 L2 bx, been waiting on a trial to come along and just got a call from Cedar Sinai saying they have a new trial phase II, and if I was interested, has anyone heard of ABT-450, ABT-333 and ABT-072. it is being developed by Abbott, this trial is to determine the safety, tolerability, pahmacokinetics and antivirals acivity.
not sure what this means, but I treat for 48 weeks, I was hoping to get Bocepravir or Telepravir, but not sure what this trial is, any advice would be appreciated.

[Bill1954]

I think this is the study as it’s presented in clinicaltrials.com; I’ll try to read through it later when I have more time:

http://clinicaltrials.gov/ct2/show/NCT01074008?cond=hcv&intr=ABT-450%2C+ABT-333%2C+ABT-072.&rank=1

Bill

[Bill1954]

And:

http://www.hivandhepatitis.com/hep_c/news/2010/030510_b.html

[Javi1962]

Hey Bill,

thanks for looking into this for me, I googled and found some info but very vague, since I only seem to have a 1 chance on a trial, since everyone wants a person who never treated before, I want to make sure I get into a good one, and BOC and TELE are the only 2 familiar ones to me. thanks again:)

[Gee704]

Check out this trial:

http://www.clinicaltrials.gov/ct2/show/NCT01023035?term=chc&recr=Open&rcv_s=11%2F18%2F2009&rank=1

I am 5 weeks in and very happy with results so far.

Good luck and let us know how you are doing!

[Javi1962]

I tried for this trial, but did not qualify because they said my hemoglobin needed to be under 15, and mine was 15.6? but this is the original trial i wanted, how is it going for you good? you said 5 weeks and happy with results? like what results are you getting are you u/d??

[WriteItDown]

Hi Javi,

When we were deciding on a trial for my husband I did a lot of research on the compound involved.  I Googled it and read everything I could, looking specifically for info about how quickly viral load dropped and on what dosages.  I would do that, see how effective and potent the compounds are.  Also ask your doctor how good he or she thinks this trial is.

From what I could tell giving this trial a quick look, it didn't seem like they have a very good handle yet on what their eventual protocol may be. It's a Phase II trial, which is less good than a Phase III.  Also, they are not specifying as their primary outcome the number of patients who attain SVR.

I agree that you should hold out for a really good trial.  I wouldn't rush into anything if I were you.  I'm sorry you didn't get into the Boceprevir one -- that one was excellent, but there's no getting around the Hgb thing.

[Javi1962]

Thanks for the feedback, I did google it but it does not say much as far as svr success rate, and there is 3 agents involved Abt-450, Abt-333 and Abt-072, and my understanding of what I am reading is that it's a blind study and you don't know which of the 3 above you are being treated with, which really makes it harder on the research because you have to research all three.

I think I am going to proceed with the appt. for the trial and see if they can better answer my questions there, very confusing this trial, I am very familiar now with BOC and TELE, and there coming out soon hopefully 2011 or 12.

thanks, J

[Gee704]

I squeaked in at a 14.9 and I feel very fortunate. As of my latest blood work, I am officially anemic and have been randomized into arm 1, ribavirin dose reduction. My latest PCR will be returned Thursday and I am looking forward to the results. As of week 2, I was not UND but had a 50% drop in viral load. From my CBC (TW 4) yesterday, I was very pleased to see my ALT/AST in the normal range. That required a celebration in my book. I am very hopeful and sought out this drug in particular after reading all postings here and research on boceprevir itself.

[Bill1954]

Too bad it’s unethical to create anemia in order to qualify. A guy could borrow some ribavirin, predose, and easily qualify for this study’s hemoglobin parameters…

Bill

[Gee704]

I was waiting for "someone" to chime in with a solution. Nice Bill!

My trial coordinator told me even though Schering wanted a broad sampling, it's all women at my study site.

[WriteItDown]

For me, the fact that little information comes up in a search could be a sign that they are still in pretty early stages with these compounds. Also, the fact that they are testing all three at once in different arms. You want a trial where it seems they feel pretty confident that the drug is going to work to get you SVR, and they are just trying to determine the correct dosage, duration, etc.

In my husband's trial the five arms were: TMC435 (the trial compound) in two different dosage amounts (75 mg and 150 mg) and two different durations (12 weeks and 24 weeks). The other arm was placebo. The primary outcome was number of patients with SVR. There was already research showing that most patients reached UND after 4 weeks of treatment with either of those doses; the higher and lower dose used in the Phase IIa trial had already been dropped. You want to look for things like that.

Enrollment is another issue.  Usually a bigger enrollment means the people running the trial feel that they're closer to determining an actual protocol for the drug -- they're betting more on the trial and they're willing to spend more money. This trial is only enrolling 75 people, compared to by husband's trial which enrolled 400. The Boceprevir/anemia trial is enrolling 660.

I would also take a close look at how other trials are designed so you can get a feel for what to look for. I would personally approach this trial with skepticism. You are treatment-naive at a pretty early stage. If I were you I'd hold out for a very good trial, or wait for Tela or Boc to be approved.

[WriteItDown]

There's another thing I wonder about in this trial's design: why are they doing three days on monotherapy with each of the new drugs first? Do they think this monotherapy will improve the chances of SVR, or are they just looking for data on how big a log drop they can get from monotherapy? At least with the protease inhibitors (I believe one of these three drugs is a protease inhibitor), resistance is created during monotherapy, and none of the protocols thus far call for any monotherapy to start with. I don't know anything about the polymerase inhibitors and monotherapy, but I would ask about this.

[Javi1962]

went to screening and it is a totally new trial, they have no real data on this trial, there still trying to figure out right amount of dosage and safety, which for me I need to be more selective for now, since I only have one shot at a trial as a tx naive patient, so nurse at Cedar Siani put me on list for any other one that pops up. she said BOCE and TELE they do those trials there, but there pretty much done with it, she said there probably finished with trials for now, this should be coming out 2011 or latest 12, she said.
if nothing else since im F2 i probably should wait till 2012 and just follow up with LFT or ?

[WriteItDown]

Sounds like the right decision for you at this time. I would keep looking at trials as they come up, and ask your doctor about them. If you have decent insurance the Telaprevir should be out within a year or so, so that is always a good option, depending on how anxious you are to treat and what your doctor thinks.