Appt for study!! Need help with what ?? to ask them please

[270217-1b]

Just got the call yesterday regarding getting into the phase 3 trial of alisporivor/debio25 [sp?] here in San Diego.  Am excited and very nervous.  The appt is on July 5th.  I need your help on what questions I need to ask them when I go in as I haven't a clue.  This is the initial appointment and was told they would do lots of labs and go over paperwork.  My doc is really pushing to get me into the study as he thinks I will be a good fit.  I have saved some prior posts and am beginning to compile my questions, but I don't really know where to begin to know what to ask.  I do know the study has 5 arms, and one of them IS a placebo arm, but even the placebo arm gets the SOC.  I have high blood pressure that is well managed on 3 meds, but worry that it might knock me out of eligibility?   What other things might??  Everyone here is so helpful, thank you in advance for anything you might come up with to ask.  I am otherwise healthy and have been working on losing weight, but still have about 30 lbs to go to be at what would be considered "normal".

[susan400]

I was actually in a Debio-025 3 yrs ago.  It was just Debio and SOC though and I was unfortunately, kicked out at week 5, because of my week 4 blood draw.  Since I didn't have enough of a viral load drop.  Don't be nervous about it.  Just ask alot of questions.  Also, please don't base your decision on my experience with the Debio trial as, I have treated too many times to count and thus far, NOTHING has given me viral clearance yet.  I'm currently in a trial for CTS-1027 + SOC and I'm trying my best to think positive, stay healthy as I can and PRAY!    Susan400

[270217-1b]

I am surprised to not find any chatter on this forum about this drug or it's trials - There is so much talk about treatment, but none I can find on here, other than the couple of questions I have asked.   makes me a bit nervous

[susan400]

I've been in a few clinical trials.  Here's the primary questions I ask.  Are rescue drugs allowed?  When will the trial be unblinded (if it's a blinded trial).  What are the potential side effects of said study drug?  Will SOC be on each arm (since I was burned by one trial where I ended up in the no Riba arm)?  If it's a placebo trial..(will they automatically roll you over onto the real drug)?  Do you need to have viral clearance by week 4?  Or is it just a 2 log drop?   Are there any drugs on the trial (such as OTC meds, pain meds, sleep meds, antacids, vitamins, etc.) that are not allowed to be taken with the study drug and/or the Hep C meds?  Those are just some of my questions I ask, right off the top of my head, that I can think of.  Susan400

[willbb]

http://www.hivandhepatitis.com/2011_conference/easl2011/docs/0408_2010_a.html

[willbb]

My link didn"t look right ..maybe try this

http://www.medhelp.org/posts/Hepatitis-C/Things-to-ask-before-participating-in-a-trial/show/1497138

[willbb]

Hi there    below is  the results from their 2 b trial...it shows approx 76% SVR  which is a good result.  however as lapis has mentioned .there are a number of things to think about when considering entering a trial  I have put a link below of a thread that one of our members put up a couple of months ago..in regards to question that should be asked  with regards to entering a trial ...hopfully the responses  are helpful

Good luck

Will

order=107http://www.hivandhepatitis.com/2011_conference/easl2011/docs/0408_2010_a.ht


mlhttp://www.medhelp.org/posts/Hepatitis-C/Things-to-ask-before-participating-in-a-trial/show/1497138?personal_page_id=1008846#post_6838455

[270217-1b]

The study is listed at clinicaltrials.gov under the name Alisporivir.  Here is the link

http://clinicaltrials.gov/ct2/show/NCT01318694?term=alisporivir&rank=1

I appreciate the questions and will add them to my list - Thank you!

[lapis]

I had to look up this drug to give any kind of response.  Here is a link to the EASL presentation of the results of the phase 2 trial.

http://www.natap.org/2011/EASL/EASL_08.htm

I went to clinicaltrials.gov and only found two debio trials but one is completed and one is ongoing but not recruiting.  Both were phase 2 trials.  I wonder why a phase 3 trial is not listed here, seems like it would be.

The drug looks interesting.  It acts by its affect on the host protein of the liver cells, rather than being a direct-acting antiviral, like the PI drugs are.  So here are some questions you might ask:

What is the tx for each of the 5 arms?  What is your chance of getting SOC only vs getting the study drug?  Does the study drug have additional side affects?  If you become anemic or neutropenic, are rescue drugs allowed?  Will your tx be response-guided or randomly assigned?

This is just a beginning, but I'm bumping you up to the top in hopes that someone else will chime in.  GTG now.  Best wishes to you going forward.

Lapis