Hep C Trials of VX-950

[JER22]

Are there any trials of VX-950 now enrolling volunteers either in the US or abroad?

[doglover28]

Hi,
I think I read in several posts down that one a big one is beginning in Aug.  I will see if I can find it and get back.

[can-do-man]

Hello and welcome, Go to this site put in hcv,your state or others.

WWW.clinicaltrials.gov

It shows what trials our ongoing. Best to you

[Upbeat]

I received the following e-mail this morning from Vertex.

Thank you for your recent email inquiring about the clinical trials for
Vertex's VX-950 compound, being developed for the treatment of
chronic Hepatitis C.


A Phase 1b study is in progress in Europe, and a Phase 2 study will be
initiated in the US by the end of 2006; however, these are small
studies that will recruit subjects from their own clinics.  The larger
Phase 2 multi-center study will start in the United States in early
2006.  The location of clinical sites is being finalized now.  This
study will include patients who are "treatment-na

[Pdilly]

Oh sounds good.  I may call tomorrow.

[Pdilly]

Are you two going to check this out?

[can-do-man]

One thing you might want to remember is that to get in these trials requires a bx. And in these early trials they exclude anyone with cirrhosis. Not saying you have it but if i was you i would do the fibrosure test soon. At least for a guideline on where you might stand damage wise. Just my thoughts, best to you.

[doglover28]

Hi All,

I hope everyone had a good weekend.

PDilly,  I guess I will need to wait and see what the specialist says when I go back on the 22nd of June.  At our first visit, he said there was going to be a study coming up at Duke this summer. He went on to say that maybe I could get in the study.  I don't know which one he was talking about. Something about Interferon along with some enzyme.  I had the my ultrasound already, but not my biopsy yet  I spoke with his PA and she said they don't set up the biopsy until after veiwing all the bloodwork results to see if the paitent even qualifys for one.  I definately want one.  

Upbeat,
Thanks for posting the info on the study.

Hi Can-Do-Man,
I hope you are doing well. :)


Pam

[Pdilly]

I have my bx on Thursday.  I won't know the outcome until July 3rd as the doctor will be on vacation.  If I am coherient on thursday I will ask him about it.  Hopefully I don't have cirrosis. I will soon find out.  I wish they would allow cirrosis patients to do the trials too. I mean what would it hurt?  It may help them tons.

Hope everyone had a wonderful weekend.

[can-do-man]

In the early trials of any of these drugs. They want to show the best results. Thats why they don't treat the non-responders, or people who have relapsed, or people with Cirrhosis. But if in the early trials the results are good then they start on the different stage of people. They just need to show these drugs work first. So they go with the best odds to begin with. Hope all is well

[can-do-man]

Thanks, i'm having a much better day. Hope your doing ok

[can-do-man]

If you go to this site and put in hcv, your state it will show you all trials going on. And if in them they use placebos

WWW.clinicaltrials.gov

[doglover28]

Thank you!  I am going to check them out right now.  You all are so great!!  Can-Do-Man pulled me out of a funk yesterday with just a few words of wisdom.  I am grateful for that

[doglover28]

PDilly,
Good luck with the biopsy on Thursday. Please keep us all posted.

Can-Do-Man,
I am glad your day was better. :)
I woke up nervous again, but I got out of bed, weeded the garden, rode the mountain bike 14 miles and swam. The awful nevousness about the unknown just left me. Thank god!! The condition of my liver will be what it is going to be.  I just have to take good care of myself and have faith.

[doglover28]

what is your take on what the specialist doc's PA said to me over the phone about "qualifying for a biopsy."  
My primary care already diagnosed me first as having the antibody to Hep-C, and then the actual virus along with the geno type of 1A.
She said this would be discussed at the next visit.

[Pdilly]

It is hard not to read something into what they say.   If I remember right you said that the scans turned out okay. I remember you are a geno 1 but wasnt everything else low too?  I know what you mean. Some days I am so nervous and others I am so laid back.  Once we find out all the guess work it done and then the road to tx begins. Its the not knowing that is the kicker in all this.  

[can-do-man]

qualifying for a biopsy? I think either the person miss spoke, or just didn't know what they were talking about. The main worry would be your platelet count. (blood cloting time) which they would already know since you've had blood test. Besides your count would have to really really low for that to stop it. And i'm sure thats not a problem. Since your a geno 1 there should be no question about having a bx.

Glad you went out today, keeping busy keeps the mind from wondering.

[doglover28]

you hit the nail on the head...it is the not knowing.  I have always been a big worry wart.  Even as a child.  
My scans did turn out fine.  The tech said if he didn't know from my chart that I had Hep, he wouldn't know by looking at the scan.  He showed me the blood flowing through it. My spleen and kidneys all looked fine, too.  
My ALT was elevated during my routine physical...It was 48. When the doc ran more test, which included the Hep-C antibody, he checked the ALT again, and it was 24.  
Have you had a scan done?

[ohgreat]

Hey Pdilly... I was going in for my Biopsy today, but they called me and told me the radiologist was out eating hot dogs at the lake or something (Memorial Day).  So I am rescheduled for next week too.  I will be sending you my best wishes in my thoughts and prayers and stuff.  I follow up with mine next monday.  You'll be just fine I am sure.

[doglover28]

Thanks!  Yeah, I guess she said that because I wanted them to schedule the biopsy before the next appointment. I must be getting a little anxious to get the show on the road.
Actually, it would probably be good to wait until the end of summer to start treatment if possible.

[cuteus]

If you choose to do tx for hep c, and have  insurance that will cover it, I would do that before any trial. These trials have many restrictions and limitations and if you do not respond as per their expectations, they might drop you and you might  then be labeled as a non responder and unable to get in other trials. Research thoroughly how the trial is going to be held. whether they will drop you at, for example if you don't respond by wk 12 or will they continue you on? Will they use rescue drugs if needed or lower your doses, therefore lowering your shot at SVR? These are just some things to consider, there are more and every person should ask very specific questions before entering the study. You don't want to waste your time on something that will only benefit the researchers.

[doglover28]

I am glad I read your post.  Thanks for that info.  :)

[can-do-man]

Cuteus makes some very good points. Their guide lines are set in stone. Cuteus got me thinking and since i had insurance i talked to my hepo. Glad i did as most trials won't give rescue drugs. But lower the dose, and early on in tx. That might cause you not to have the 2 log drop and out you go. If you have little or no damage and want to go the new drug route i would suggest you wait till their trials our further along.

[doglover28]

Do some of the people get placebos on trials?

[can-do-man]

With some drugs and in early trials yes. I could be wrong but i don't think vertex is one of them.