Zlikster and others

 Finding Clinical Trial Contact Numbers

Go into clinicaltrials.gov  

Put hepatitis c and a city and state

Just start opening trials

Go to locations and see if local contact numbers are listed.

Nothing listed--Go to next trial.

I listed Arlington Texas and opened first trial listed

It was #NCT 01492504

When I opened this particular trial there were contact numbers for many clinical trial locations. There is generally only one trial site in a city and each site does many different trials for several different companies.  So if your trial does NOT list a contact number---go to the next trial and see if a contact number is listed on that trial for your desired location..

Check out #NCT01292504 and see all the contact numbers listed under this trial.  Call the numbers and tell them what you are looking for--like genotype, treatment naïve or not,etc,  I was really shocked at how many contact numbers were listed for this trial.  Another trial at the same location may not list any local contact numbers.  My trial site has only one number no matter what trial you are looking for. So call that number and ask about the trial you are looking for or just give your info and ask to be put on their list for an appropriate trial.

Doing clinical trials is a business and if they don't have participants, they won't have a business.  They need us as much as we need them.

Hope this helps.

SuziQ

Zlister,

So, contact Cheryl and ask her about it.  By the way, Cheryl has a PhD in clinical research and is in charge of the testing center under Dr Reem Ghalib MD.  I'll see if I can find some more direct addresses at other sites.

SuziQ

With Gilead trials, I googled and got lists of potential clinics in the areas mentioned and just called, asking if they were conducting any Hep C trials and asking to be contacted.  I didn't say, necessarily, I want this or that one, because at that stage I wasn't sure which I qualified for and also had the best stats.  Its  better, I think, to have too much info rather than not enough. 

Zlister,

Did you notice that Arlington Texas (my test site) is on that list??

SuziQ

thanks girls :)

thing is, for my GT, only trial suitable atm is Gilead's Sof+Rib (one arm with peg too)...there are numerous locations, but nothing except address of locations is provided. Only contact mentioned is Gilead's program manager.

I guess i will hunt down by location, what could be hospital/site and try to email/call for possible participation.

Will send to Cherly email again saying i can travel whereever they can accept me...in meantime i gotta do FibroTest and 24w EOT PCR next week and in January FibroScan.

cheers!

Hi Zlikster,

Karen is right.  The test sites choose the candidates.  And the test sites get paid for each person they test.  Email Cheryl and let her know you really just want a trial WHEREVER( and the doc there is female, not he)Get your medical records in English and send to every test site you talk with.  I'll talk to her when I go in Dec 30th.  San Diego Calif also does a lot of tests.  It is a great place to visit. Maybe Karen can send some numbers or email addresses by private messaging to you. I may have some Calif addresses.  Just ask for your genotype, etc.  Who knows what is coming up. 

SuziQ   

Hi Zlikster, I was in exactly your situation a year ago and got nowhere calling drug companies directly.  I wound up almost randomly contacting centers, both private and public institutions, and getting on their lists of interested participants.  When clinics finally began calling, I actually screened for four different trials before I found one that was right for me.  It was nowhere close to where I live so I spent a month in a hotel and then lots of time flying down on a weekly and bi-weekly basis.  You have to be, in my experience, very proactive and be willing to spend a lot of time making telephone calls, etc.  For me it was worth it.  Good luck!!!  Karen

Thanks SuziQ :) don't worry i got friends in states, i got a place to sleep and work in NYC as for TX i would rent some flat, everything is better than 168k $...if anything opens for my case in USA i will hop there. I don't wanna bug your doc again, she said he will send me email if something pops from clinical trials for GT3s

watching the news, artificial heart implanted in France. First ever. Huge operation and intensive care, cost 240k $...something is just plain wrong when a pill costs 1k $...meh, sorry me and my greedy pharma rant again ;)

hopefully someone from Gilead will respond...until then, lets see whats hcv doing in my liver (seems to be on the active side since relapse).

best

Zlikster

The Arlington Texas center is where I am doing my trial.  Contact Cheryl again and let her know you are willing to consider it IF she has any openings and you want to give it a try.  I would let you stay with me BUT I have 18 cats and 3 dogs and it is not acceptable.  I could however meet you at the airport and help you get settled.  Anyone else live near a study center for this trial??

SuziQ

NYC, USA or UK is ok with me since i got friends there, but actually anywhere in the world i would travel and stay up to 6 months to do clinical trial (everything is cheaper than 168k $ for 168 pills). You think i should contact hospitals/locations directly and not over Gilead's trial manager? i only can find study locations without any further contact (tel/email/name of hospital), only contact there is, is a main program manager (7977Phase3@gilead.com).

http://clinicaltrials.gov/ct2/show/study/NCT01962441

i can check on google maps tho, are there any hospitals on those locations and try to contact hospitals directly?

i am going next week to estimate hearing damage from last round of interferon. As i mentioned before, i wouldn't mind going again thru interferon based tx, if i only knew my hearing would be not compromised further. I can bear with low neutrophiles (hello Neupogena) and all sx from it :) in next month i will know will they offer me retreatment with Peg n Riba again...

thanks SuziQ once again...i am bit down to be honest, gilead's manager asked my hepa can her/my hospital pay for Sovaldi for me, so there seems to be no help or discount getting from Gilead for Bosnia any time soon.

i doubt any insurance in the world would pay for 6months of Sovaldi to GT3s patients...i wonder will anyone from noncirrhotic GT3s on this forum get Sovaldi via regualr insurance/healt care way.

cheers

Hi Zlikster,

I could be wrong, but I think Gilead does not really decide who does clinical trials--their study sites make the calls to those on their lists--people that have their medical info already on file with them.  So your connection needs to be with study sites.  Cheryl said she understood that you only wanted to do a trial in New York??? Did she misunderstand ???  Just contact study sites in areas where you are willing to go.  One will show up for you.  I'm rooting for you.

SuziQ     

cheers SuziQ...i just got reply from Gilead (i've sent 3 emails, in October, November and December) that they are full for Ledipasvir/Sofosbuvir (+Riba) clinical trial in USA :(

still no reply for Sofosbuvir/Riba one (9 more new locations in UK showed up!) :(

I just got an email from a friend that she is starting this combo on Jan 3.  They have a new trial for 400 people starting then.  It probably is in the US only at this time. ( Sorry Zlikster, I keep looking for one for you) It is for non- cirrhotics  and null responders,  It says it is not recruiting on the clinical trial site BUT IT IS recruiting thru their study sites. My Merck trial just recruited thru study sites and posted on the clinical trial site later.   She did her screening 12/16 and has a start date of Jan 3. 

It is so important to get connected to a study site to get into the clinical trials. 

SuziQ

Hi Ssveta,

i presume Ukraine is pretty much same with availability of new hcv drugs as Bosnia is (actually i think Bosnia is in a worse place).

Boceprevir or Telaprevir (Incivek/Victrelis) go with drugs/therapy you have already tried Ribavirin and Pegylated Interferon (Pegasys +Copegus). It so called triple therapy and it is indeed in last couple of years a recommended therapy for hcv genotype 1 patients. It is more expensive than just dual therapy you have been on, so lower income countries still do not have it. In Bosnia they said it might be available next year and it will cost (est. 55k $).

As you might have heard, there are new amazing drugs on the horizon. Some still in clinical trials, some already approved in USA (Sofosbuvir aka Sovaldi and Simeprevir aka Olysio). Sofosbuvir price is 84k $ per 12weeks and for genotype 1 it will be used with interferon and ribavirin. Chances of cure (well, SVR that is) are high. I doubt it will be available in Ukraine that soon. If your liver is in a good condition, consult with your doctor shall you wait for those new drugs to become available or if not, to get asap to new round of therapy with Incivek or Victrelis when it becomes available in Ukraine.

you can also try to get into clinical trial. There are plenty of clinical trials for GT1 patients. Please check www.clinicaltrials.gov and check are there any close to Ukraine (or even in Ukraine) and consult with your hepatologist.

all the best

Thank U so much for this web-link!!! I won't find it by myself. I will check this trials.I'll be in touch and inform about our treatment.

Welcome to the forum! We have some members that live in the EU and surrounding countries. I'm sure that once they check in and read your post, you'll get some additional information that will hopefully help your Mom. I found this information on trials in the Ukraine, some are closed but there are still some open trials out there. Take a look at this information and contact them for additional help. The NHS has trial info for many areas, I hope you find something helpful. Here's the link for the Ukraine info:

http://www.nhs.uk/Conditions/Hepatitis-C/Pages/clinical-trial.aspx?CT=0&Rec=0&Countries=Ukraine

Be sure to take advantage of our search function at the top of each page. It can save you a lot of time. Feel free to introduce yourself in our New Member section and let us know a little more about your Mom's condition and history if possible. That helps us answer your questions better. Good luck, and keep in touch. Your English is excellent by the way!!

Good night everyone. PLEASE  HELP ME with INFIRMATION!!!!! 

I need to treat mo mother (49 years, hepatit c; genotype  1B, relapse in 2007 year after double-therapy : Pegasys+Copegus). We are from Ukraine, Our doctor tells us that Boceprevir +Peg+Rebaverin is the best choice for us. Telaprevir/INCIVEK  is not yet licensed in Ukraine .  I've read (was trying to read, because my English is not fluent) about Sofosbuvir,Daclatasvir, Ledipasvir--- but I cant get the proper information-- are they already licensed somewhere in the world? how much do they cost? In what Country and CLinic  my mam  can be treated with them? Here in Ukraine there is no information about this new inhibitors AT ALL.      

  Thank U  beforehand

Hi, Millercollaborative, I wrote You a PM , Please reply - thank you

Hello Lauralou57

That trial has had some good results so far, it is made up

a combination of daclatasvir, from a promising new class of drugs called NS5A inhibitors, a protease inhibitor called asunaprevir, and of BMS-791325  a non-nucleoside polymerase inhibitor.

Here is a link from HCV news http://hepatitiscnewdrugs.blogspot.com/search/label/daclatasvir%2Fasunaprevir%2FBMS-791325

Also check out the forums thread about entering a HCV drug Trial 

matt

Thanks for your feedback! I live in Arlington, VA near the Pentagon and my Hep C doc is in Baltimore, Md.  and he will be coordinating the trial.

If I go through DC I can be in Baltimore in an hour or less.  I have been going to my Hep C doc since 1999 and I trust his judgement.

I have a good job with lots of leave I can take. I have spoken to my boss and he is aware of the time commitments and has no problem with this.

Even if I need to go to Baltimore several times a week I will not have a problem. I have family in Baltimore, Md I can stay with if I have to.

My hep C doc has tried to get me in several other interferon-free (interferon gave me severe migraines every day) clinical trials but had trouble because I do not have much damage to my liver.

When I went on interferon and ribaviran in 1999 my viral count went UP (ugh!) not down so he took me off of it.

My hep C doc told me this drug combination showed few symptoms.

I will post again if I get in and let you know.

Thanks so much for responding to my post!

Hi Laura, I haven't met anyone else on this forum who has been involved with the BMS trial except me!  I was treatment naive, and 1b, and was clear at the third week of treatment-I'm now SVR at 24 weeks.  In terms of symptoms, it was a great study.  I didn't have any side effects at all.  BMS is very particular about blood draws and requires a bit more time commitment than some other trials, but to me it was well worth it.  I spent a month in a hotel at the beginning of treatment just to participate, and then flew down to the clinic site every week, then every 2 weeks, etc.  Where are you located?  I did the clinical trial in Falls Church, VA. Best of luck!!! Karen

Today my Hep C doc told me he could get me into a clinical trial with daclatasvir, asunaprevir & BMS-791325 for 12 weeks and he thought I should try it.

I am a treatment-experienced genotype 1A.

How have the other treatment-experienced 1A's in the forum done in this trial?

I would truly appreciate any feedback.

Thanks!

Hey Karen 

Thats really good news, I guess every time we get a slight elevation we get anxious and rightly so but the more that time passes the more are concern will fade.

Karen it's nice to hear you comment about the limited side effects, because that is one of the goals of all the newer HCV drugs in development.

Hope you will continue to achieve UND

Matt

That`s fantastic, Karen, and what a relief it must have been for you!  Liver enzymes can fluctuate for various different reasons, but I can understand you being anxious, that`s only natural.  You went to great lengths to get onto this BMS combo trial and your efforts have certainly paid off.  Congratulations, and thanks for sharing your good news with us! 

Congratulations!! Those kinds of nervous conditions can drive you nuts, lol! I'm so glad the news was great for you 

There was a discussion on the BMS treatment earlier today here on the forum. You may be interested in the information. 

http://hepcfriends.activeboard.com/t55034091/drugs-in-development-phase-3-genotype-1-daa-plus-pegrbv/#lastPostAnchor

Hi folks, another update-had a scare last week when I had labs done for my hepatologist in preparation for the six month ultrasound-while most of the numbers were great I did show very slightly elevated liver enzymes.  My hepatologist sent me for a HepC quant test-and I went through almost a week of jitters awaiting the results-still  UND at almost 6 months post treatment.   

I do want to say a good word about BMS-this combination of DAAs seems to be pretty darn effective with almost no side effects and a very high rate of SVR-I haven't seen any actual results published yet but this is the scuttlebutt and certainly my personal experience.  I don't know if there are any opportunities for a clinical trial at this point, but its worth looking into, expecially if you are, like me, cirrhotic and 1b.  Good luck everyone!!!

Great story and great job!!!

Excellent news, Karen, congrats!  Your perseverance and determination has really paid off, well done! 

Thanks for sharing your journey with us, and all the best for a healthy, Hep C-free, future!

Hi Karen,

Great to see another 'mature' person get such a great result. Those of us who have had HCV for 40+ years feel a special sense of relief. Let the liver start to heal itself and enjoy life! Cheers.

It is always wonderful to read that yet another person is Hep free. Congratulatins :D

Congrats Karen

That is fantastic news , you did very well in picking the right Meds.and the trial that work for your condition. That Daclatavir is a very special Tx. Wish I would have.

Welcome to the rest of your life.

Matt

God bless you Karen for continued good health!  

Just an update-at 12 weeks post treatment am still UND.  Just to summarize, I am 1b, cirrhotic, and had hep C unknowingly for over 40 years till diagnosed in June 2012.  I searched all over for a clinical trial and wound up down in Virginia (I live in Vermont!).  I stayed in a hotel for a month for treatment, then flew down every week, then every two weeks, then every month or so.  Next check in in October.  The trial doctors and nurses were wonderful throughout the process and I am eternally grateful to them.  My best and healingest vibes to everyone who is currently in treatment or trials-hang in there.  To those waiting, it won't be long till these drugs are accessible everywhere. 

Good Luck Karen,

Your future looks bright

Thank you so much for this information When interferon/ riba  free treatments come out I think I'll be first in line

keep moving forward

Bill S

Hi Karen, what great news, congrats!  Really pleased for you! 

Thanks for the update... we are so thankful to hear from all of you who take part in these clinical trials, it gives us great hope and encouragement for the future of Hep C treatments!

It`s looking good...best of luck with your next blood draw in July!

Great news Karen, have a great day !!

Thanks Matt!  I'm so happy for you too.  I have another blood draw in July and am knocking on wood and wishing on stars nightly. 

Hey Karen

Thanks,  that is great news.

Sounds like you and I are on the same EOT time schedule, I also just received my 4 weeks EOT UND and now have 3 weeks until the next (8 weeks Post treatment)  result come in.

I must admit this waiting and keeping positive is harder that I thought, but what I learned is keeping my good habits of diet and vitamins, exercise and prayer help keep the vision going.

Wishing you all the best

Matt

WooHoo! Just the kind of stuff we love to read....Congrats Karen

Hi, just thought I'd update with my latest information - 4 weeks post treatment and UND.  It was lovely news!  In case anyone is thinking about this clinical trial, I recommend it - although its very demanding in terms of clinical visits, the success rate has been remarkable and there have been very few side effects.  I didn't suffer any.  Still keeping my fingers and toes crossed. 

Hi folks, I started this trial about 9 weeks ago and end treatment at the end of this month.  Is anyone else in this trial?  Its very intensive in terms of clinic visits but seems to be having good results.  Karen