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Clinical Trial - How to go about it
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Clinical Trial - How to go about it

Hi,
My mother has Hep C 1b and her doctor recommended a clinical trial for her (instead of mainstream therapy).  It appears that they are recommending this trial for her:

but I have several concerns regarding this trial:
There is a placebo portion.  What does that mean? Does it mean she may end up taking placebo and just waste her time? Do you guys know how this works?
http://www.clinicaltrials.gov/ct2/show/NCT01732796?term=houston+hepatitis+c&recr=Open&rank=24


I looked over this forum and it appears that this is a very good trial from Gilead:
http://www.clinicaltrials.gov/ct2/show/NCT01726517?term=GS+5885&recr=Open&rank=1

I am not sure why our doctor is not recommeding this trial for her. Do you know if we can just go to the clinical coordinator and ask them to sign her up for the Gilead trial and not Boehringer Ingelheim trial?

Any advise would be appreciated. She is treatment naive and 66 years old.

Thanks
13 Comments Post a Comment
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4113881_tn?1390588112
Hi...Im not real informed on clinical trials but there are a lot on the forum that are. Im just responding to bump your thread up as I see it got lost on the bottom. There are a lot who are in trials now or who have gone through them. Hopefully they chime in soon....Ive bumped you back to the top.

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Avatar_f_tn
"hcvadvocate.org/community/trial.asp" gives directions and links to trial info.
Best To You

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180992_tn?1383377657
http://www.hivandhepatitis.com/hepatitis-c/hepatitis-c-topics/hcv-treatment/3877-aasld-2012-interferon-free-faldaprevir-bi-207127-safe-and-effective-for-hepatitis-c-patients-with-cirrhosis

This info link is helpful.  If your mom is 1B and IL28B CC she has 86% chance within 16 week period.  The only placebo I see is the ARM for 16 weeks of BI drugs with Riba weight based and then 8 weeks of placebo.  The other arms are 24 weeks of BI drugs with weight based and standard weight based Ribavirin.  Since this is a phase 3, they already know that 16 weeks was pretty successful for the 1B CC women.  the only thing is all this trial ARMS has Ribavirin.  Riba causes extreme anemia in some, is rescue drugs allowed would be my question.  Gilead trial has ARM's with No Riba so they think their drugs can stand alone.  The Big thing is no Interferon!  What stage and grade fibrosis is your Mom and her IL28B geno?  When deciding on doing a trial you have to consider your fibrotic level.  Can she wait for the non interferon treatments to be approved? I think your Mom's Doctor reading the phase 2 results of women with 1B thinks your mom is a good candidate.   Reading this myself about IL28B CC being the best outcome for 16 weeks, knowing their is a placebo, I would find out what I am, CC, CT or TT.  If CT or TT then I know I have a 2/3rds better chance if I got the 24 week full triple combo Arm and not the placebo. You have to do your homework and make this decision.  
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Avatar_m_tn
"I am not sure why our doctor is not recommeding this trial for her."

There could be a number of reasons, he might be seeing better results in this trial as it is in phase 3 where the other is only in phase 2... Or it could be as simple as there are not any slots left open... Hospitals only get a limited number of slots and once they are filled that is it... Wishing your mother the best
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Avatar_m_tn
trial sounds great I would do anything to be in it , I am in Australia unfortunately we are a year behind the usa
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Avatar_f_tn
First of all,
Thank you so much for responding.
I am completely new to this... What is CC, CT or TT?
She has stage 2 to 3 moderate damage...They said she needs to get treated within 6 months...

Are you saying that Boehringer Ingelheim trial is ok and we should not push for Gilead?

How do we know what ARM we are getting?

Thank you so much, guys
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901131_tn?1293748153
First off why does she HAVE to treat within 6 months, Stage 2-3 is moderate damage but not life threatening. Also the CC,CT,TT is not relavant with these new drugs. Gilead by far is the better choice the are so much farther advanced in trial and results. That being said i'm in a BMS trial in my last week of 12 and have been undeteted since week 2. I know Abbott has some very good trial results also, Boehringer Ingelheim I am really no familar with. PUSH for Gilead or look into an Abbott or BMS trial there coming out with more really soon.

Bob
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901131_tn?1293748153
If the only opportunity she has is the Boehringer Ingelheim trial I would seriously consider it. These new DAA drugs have all been doing miracles, check out Gilead and Abbott plus BMS but take what you can get because trials are starting to wind down being phase 3 there getting ready to submit next year.Good luck
P.S. I did look at the stats on the Boehringer Ingelheim drugs and they do look really good so far.

Bob
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Avatar_f_tn
Hi islitsa,
There are many things to consider when thinking about going into a trial.  Your mom will want to make sure that she understands all of the fine print regarding the trial.  She'll want to ask whether the goal of the trial is medical intervention, what will happen if she is in the placebo arm (i.e. will she receive the trial drug later), if the trial drug doesn't work, how long would she have to wait to treat with another DAA or other future medication, will the results be open or blinded, etc.  Her age may also be an important factor to consider with regard to either trials or treatments.  These are all questions for her doctor and/or for trial coordinators.
While I agree to some extent with Boobert that Stage 3 is moderate damage, there is no way to know when your mother may transition to Stage 4, Cirrhosis.  That transition can hope over years, but as in my husband's case, it can happen more quickly.  This is probably why your mom's doctor would like for her to treat sooner rather than later.  Here is a link to an article that I have saved in my journals.  It was shared on this forum by a member named specda, so I would like to thank him for this useful information about considering clinical trials:
http://www.medhelp.org/user_journals/show/332520/Clinical-Trials-and-Medical-Research-in-Hep-C
Advocate1955
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766573_tn?1365170066
There is lots of good information on here about trials and I have no doubt you will find answers and the trial people will probably not lead you astray. Meanwhile I encourage you to learn more about your mum's condition. It seems like you know a lot already but I would ask for a copy of her biopsy and post some of the text right on here and let people go over it with you.

Stage 2 to 3 is pretty vague. That, along with her doctor's insistence that she HAS to treat within six months sounds as if we might be missing something.

If you are not doing so already now is the time to ask for copies of all labs & reports.
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901131_tn?1293748153
Stage 2 to 3 is pretty vague. That, along with her doctor's insistence that she HAS to treat within six months sounds as if we might be missing something.

Or just a misinformed Doctor, there are plenty of them out there.
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Avatar_f_tn
Hi everyone,
thank you for your advice... I do have her bloodwork and biopsy and I will publish it here as soon as i get it located.

So question is: if Gilead is a better trial and it is open in my city, how then do I go about getting into it? we have 2 clinical coordinators working with us, so do we just ask them to put us into it?
i asked one of them and he said he does not have that trial available to him. What does that mean? How do I find out a doctor that does have this trial available to him?

We are seeing easly 2 of the best hepatologists in the area and we did go for second opinion. both recommend that she gets treated quickly and both recommend clinical trials route because of negligible side effects.

Any thoughts are appreciated. You guys clearly have more knowledge on this... Thanks again
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901131_tn?1293748153
You have 2 clinical coordinators well those are the right people. Tell them your very interested in the Gilead trial. Do you know if there even is a Gilead trial open in your area? Also ask about the Abbott trial.Is the Boehringer Ingelheim trial the only one offered to your mother? Personally I would ask about Gilead and Abbott and if nothing is available I would seriously consider the Boehringer Ingelheim trial. They are having very good results also, there's just much more data with the gilead drugs.

Bob
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