Clinical trial, TMC435 for previous non-responders, recruiting

[WriteItDown]

Just wanted to give anyone interested a heads up: the Phase IIb clinical trial of Tibotec's new protease inhibitor, TMC435, for people who have previously failed treatment is now recruiting.

http://www.clinicaltrials.gov/ct2/show/NCT00980330?term=tmc435&rank=1

6 out of 7 chance of getting the trial drug.

[WriteItDown]

That's good news!  I hope it works out for you.  

By the time you start, with luck, my husband should be finished with the trial, and I plan to post a detailed description of his side effects and the results if I can.

[rexx73]

today i became email from the prof. at the uni.wich is recruiting now.
he needed some more info from my past therapy(my vl  at week 4 and 12),and he said that it looks  good that i can get in this trial.
the trial starts in march-april 2010.

good news for me today.

[WriteItDown]

P.S.  I doubt there would be anything like the database you suggested... I think it would be illegal since you have privacy rights on a trial.  In any case my bet would be the silence you're experiencing is due to simple administrative neglect or incompetence.

[WriteItDown]

Sorry, Susan, I have no idea.  We were very lucky in that my husband's doctor works in a hospital where they do many trials, and we made an appointment with the nurse who coordinates them and she told us what they had going on.  So we never even had to do anything to find out where it was, if we could get in, etc., it was all taken care of for us.

I would imagine, if I were you, the best thing might be to try to find out which hospitals and/or doctors in Orlando are involved -- maybe by calling the likely suspects directly?  Are there any liver disease centers in Orlando?  And see if they can help you.  But this is just a complete guess,  just because I always think talking to a real person beats mail or e-mail.

Sorry I can't be of more help -- I hope you get through to someone, good luck!

[susan400]

I don't suppose that you have a listing of phone numbers on this trial anywhere?  Like for the Orlando site???  I've applied for it, filled out their questionaire where it says that they'll call in 10 days,...but nobody every calls me even though it comes back and says that I've passed their first questionaire part.  It says on there, somebody will contact you in 10 days for further questions.  The questionaire never asks you if you've taken a protease inhibitor, so that is not why they haven't called. ??? Strange.  I still maintain that there is some huge gigantic database that we don't know about..., that all of the trial sites are linked into.  So that, they can plug in your name and see if you've participated in any other trials anywhere.  Since I've applied at the Orlando location and I've never treated in Orlando..., it makes you wonder about that!  Susan400

[WriteItDown]

Hi Rexx73,
Sorry, we're in the U.S. and doing the trial in the U.S., so I have no idea if your nationality will be an issue or not.  I hope not -- best of luck getting into the trial.  We've been very happy with it so far.

[rexx73]

this week i sent an email to the uni freiburg wich is "only" 100 km away from me.

i hope i can get in this trial.with the TMC435.
my only concern is, im from switzerland and the trial is in germany.i hope thats no excluding criteria.
it will take me only 90 minutes to get from my home to the uni wich is located very near the swiss border.

does anybody know if its possible for me as an swiss to get in this trial?

[ejneu]

I am on the tmc435 trial for treatment naive also. In week 3. Have done 3 shots. So far so good. I would apply for this study if I was a nonresponder. I have high hopes for these protease inhibitors

[josiejo]

I was at a seminar the other day with Dr Gordon from Henry Ford Hospital and he was speaking on the new treatments that are up and coming. He is really excited about the new PI'S .....patients receiving the combination of R7227 and R7128 for 14 days – without pegylated interferon or ribavirin. He said that he had heard some rumblings about some very positive outcomes with these two drugs. They will be releasing all of the data from the 11b trials in Europe on Nov 3rd. If all goes well then they will be doing a large phase 3 in the US in the year 2010. Like you I have treated so many times and was in the "C" arm of the vertex study. Had to drop out due to the rash.http://www.roche.com/investors/ir_update/inv-update-2009-04-27.htm

Joanne

[susan400]

Thanks, WriteItDown, so do I!!  Susan400

[WriteItDown]

Hi Susan,

We were told they would get in touch with us by a certain date and it was several weeks after that when we were actually contacted. So that might not mean anything, though I agree it's possible that a previous experience with Telaprevir could be an issue.  I do think there are many new protease and polymerase inhibitors in development, and some of these may well have different resistant variants associated with their use, so that could be your miracle....

Whatever happens I wish you good luck, and I have to tell you, I am so impressed by your bravery and fortitude -- 10 treatments, wow!  You deserve SVR, hope something comes through for you!  

[susan400]

I've already sent in the Orlando site, the initial on-line registration process.  They were supposed to call back in 10 days, but nobody has called yet..., even though they said that I was approved for the first 8-10 questions they asked on-line.  I'd like for some trial to approve me, but being a Telaprevir failure, it's proved to be almost impossible..., I need a miracle I think!

Susan400

[WriteItDown]

Estimated enrollment: 455.

BTW my husband is in the trial of the same drug for treatment-naive people.  He has done 9 weeks, has an 80% chance of receiving the trial drug, and is doing well.  Perhaps he's just lucky and is someone who wouldn't have had many sx regardless, but so far he has has very little nausea, no rash, and his Hgb levels, while down, are still pretty good.

[Willy50]

Dang!!!!  That study is huge.  This looks very inclusive taking place in many countries.  Should be a great opportunity for many people.  I wonder how many they are enrolling?

Willy