Clinical Trial Application

[Verdugo]

For those of you that have participated in a clinical trial, how did you apply?

I have an appointment with my HEP on 4/15 where I plan to raise the question with him but would like to do as much of the leg work before then.  I'd like to get into the Phase 3 of the GS-5816/Sovaldi trial and am looking for info on how to go about it.  Is there anyone here who has already enrolled in that trial?

Thanks.

[Willy50]

http://finance.yahoo.com/news/gilead-announces-results-phase-3-203000280.html
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If you are not in a trial you also have some degree of control over your destiny

[Advocate1955]

I think there are two approaches to finding a clinical trial:  1) as can-do said, if you are being seen by a hepatologist who has connections with trial doctors, for example in a university based research medical center, who can put your name on a list and help get you in a trial, and 2) look up trials using www.clinicaltrials.gov website, find the ones you're interested in and contact them.
My husband's hepatologist, who is at the University of Washington Medical Center's Transplant Center, placed him on a list to learn about trials at the University of Washington Harborview Medical Center, where trials are conducted.  However, so far nothing has come up that specifically suits his needs (3 prior failed treatments, interferon non responder, G1, compensated Cirrhosis).
Additionally, I regularly search the Clinical Trials website looking for trials that might be appropriate for him, and I forward that information to his hepatologist.  We would want to find a Phase III or IV trial, non-interferon, high rate of success, goal of intervention, open study, and we would want to know what would happen if he got a placebo (i.e. would they treat him with the trial drug).  We would want to have a clear understanding of all aspects of the trial, and we would want to make sure that his hepatologist feels that it is a good opportunity for him.  We feel that he can't afford to fail any more treatments, develop any more resistance, or tax his liver any further unless there is a strong likelihood of success.
In the meantime, the Sovaldi and Ledipasvir combo is very close.
Advocate1955

[Verdugo]

Willy,  I think I may have found a doctor who has his finger on the pulse of the clinical trial scene in LA.  According to his office, as you said, you need to be on the "go" mark when the trial is announced.  This appears to be his practice so it seems like the right place.  (Oddly, or not so much, this doctor reached out to me in the form of an add on the medhelp page.  It's as if the internet is reading my thoughts.  Nah, couldn't be.)

Thanks Rosebud.  I do live in LA.  I'm trying to avoid taking Ribavirin so it might be tricky.  

You are in a trial here?  Where?  If you'd rather, PM me.

Cheers,
V.

[Rosebudfrita]

I only know of trials in los Angeles.  Do you live hear or willing to live here for a year?

[Willy50]

I had no doctor.
I did not live near near a clinic.
But I have been accepted into two trials in different states.

I saw who was running trials, picked a trial center and expressed interest, willingness, and my labs.

Many of these trials fill quickly.  You have to almost be pre-approved to be able to get in. You have to be in line.  You have to be ready to pick up and move instantly if you are seeking a trial slot.

One of the members here once wrote that in her trial..... they actually did the screening early in the AM well before other clinics. That way they could have applicants processed, picked, randomized and filled when other centers were just getting started for the day.

In my example....I was called to be screened in October..... but I never got the call in.
the reason?
The other clinics filled so fast that my clinic never got an opening for the first part, the second part I did get in and was accepted.

Pick one or two drug treatments, ask about other possibilities at your clinic so if you don't make the cut you may get into a second draft.

IMHO..... by the time the CT site says they are open and taking applications.... the best ones have filled.  So know what your choice drug, drug treatment, drug company is doing. If you miss a 3a, you may hit an even better 3b trial.
In my case the g-1's were treating for 12 or 24 weeks, then ION-3 opened for 8 and 12 weeks.

good luck!

willy

[Verdugo]

C-D, Yes, I could see how slots in a Phase 3 trial would go fast which is why I was trying to be proactive.  I called ahead to my doctor's office but got an unhelpful response.

Lynn, The Phase 3 of this trial does not appear to have been officially announced so I don't know the trial number or any real specifics.  Just fumbling around in the dark...  Hopefully my doctor will be able to steer me properly.

Thanks, V.

[HectorSF]

My hepatologist who lead all of the hepatitis trials at my transplant center called me and asked if I was interested in a trial as she thought I would be a good candidate. It was the first non-interferon treatment trial for pre-transplant cirrhotics (2 years ago when Sovaldi was called GS-7977).

I then had some medical testing done to prove that I met the inclusion criteria and no exclusion criteria.

Hector

[flyinlynn]

Hi
Would you have the clinical trial number I am not seeing a Phase 3 study for GS 5816 Sovaldi.

I did find ClinicalTrial  NCT01826981 if that is the one you are asking about.
But that one is in New Zealand.

Every clinical trial I was involved in my doctor asked me if I would like to participate. His office was a trial location.

If you want to be proactive find out what locations in your area participate in clinical trials and contact them directly or ask you doctor to do so on your behalf. Of course you would have to qualify for the trial. Lately every trial I looked at I was either too sick or not sick enough.

But now fortunatly I am taking Sovaldi /Olysio and so far so good at week 2.

Hope you find a study you can get into and are successfully treated

Good Luck
Lynn

[can-do-man]

Your Hep doctor would have to be one of the doctors involved in the trial and is the one who decides if he puts you in or not. They each have a limited number of slots to fill. I was in a phase 3 trial, those slots fill up fast. Good luck to you.