I followed that trial on clinicaltrials.gov for months and pounced the day after it said it was open for recruiting. Sent in the form to Sylogent. It looked to me like everything was okay and that I was a good candidate.
Never heard anything from anyone. So I emailed Sylogent and was told that recruiting was closed!
Today I talked with some study centers in New York that are working with Janssen, and they told me that these trials are very competitive and no one is getting in who isn't already on a study center list. It ain't fair, but "Es lo que hay" ("It's what there is" [old Spanish saying]).
Since the trials are conducted as a business, the attitude of a lot of the people involved in them is strictly business-like, and this is the way business is conducted, I guess. Like 'finders keepers, losers weepers".
Someone at a study center told me that you need to find out way in advance who's doing the trial, talk to them on the phone, try to go see them, send them test results, get on their list of trial candidates, maybe even pay a coupla hundred bucks to see an MD and become an official patient there, and then call them all the time so they won't forget you.
I hate to be cynical, but I think any idea of these trials being conducted in a democratic way on a level playing field are out the window.
One thing's for sure: clinicaltrials.gov is worthless.
Mike
Milliganus said
Jun 5, 2014
Maybe thats a good sign for you. They could have forwarded your info to your trial center who would then call you. Hope thats the case.
skewedButNotBroken said
Jun 5, 2014
At least you got a response. I have heard nothing from them. I bet tens of thousands of people applied for that trial, so being accepted would be like winning the lottery.
Milliganus said
Jun 4, 2014
FYI for all who applied online for this....I just had a response from Sylogent (the org that handles recruitment). This was the message: "Thank you for visitingwww.ClinicalTrials.gov and expressing interest in a clinical trial for NCT02114177. Unfortunately, the sponsors of that trial have informed us that enrollment for the study has closed and will not be accepting new participants. This information will be updated onwww.ClinicalTrials.govshortly."
Milliganus said
Jun 3, 2014
No doctor right now. We travel full-time and I haven't had a regular doc for many years....
tgcd78 said
Jun 3, 2014
I was fortunate enough to get into this trial in NYC. I am on day 8 of the S/O combination, 12 weeks total when I am done. My doctor was very eager to get me into the trial and helped push my paperwork through quickly with the clinical trial coordinators in his office. I think I was lucky to be in the right place at the right time. Are you able to get any help through your doctor?
Milliganus said
Jun 3, 2014
I filled out the form too....but no call. I suspect the easy to fill positions are already taken. This is what I have been hearing from a couple of trial centers I've been in contact with, that for many of the upcoming trials for these drugs which have already been tested in trials, that the FDA is wanting more trial data for select "people groups", i.e. not caucasian women or men. Don't know if that is happening with this one.
Keep us posted if you get a call.
Gator Man said
May 28, 2014
Hi Marcy,
This the same Tx regimen that I completed in early April with a physician participating in the COSMOS trial. I also am not Tx naïve, but have mild cirrhosis. I've been UND since week 4 and hopefully will be SVR when I test again in approximately 2 weeks.
Being cirrhotic, I would not be eligible for the Optimist-1 trial. Certainly didn't miss taking Ribavirin (much less inf), which seems to have support from the final COSMOS data. The Genotype 1, ILB 28 CT scores for F0-F2 were 100% SVR from the COSMOS data, with or without Ribavirin for 12 weeks. Impressive, although the trial size was small.
John
-- Edited by Gator Man on Wednesday 28th of May 2014 09:15:25 PM
I am now anxiously awaiting a call--hoping and praying...
OldenSlow said
Apr 16, 2014
Hi Marcy,
Best of luck on getting into your trial. As far as I know, that will be the first one to study the effectiveness of an 8 week treatment using the S/O combo. Also the first not to use ribavirin in any of the treatment arms. Looks like re-treatment with Sovaldi won't be a problem down the road, though you'll need to combine it with a different class DAA.
wayne
Milliganus said
Apr 16, 2014
Hi all,
Been keeping my eye out and this trial looks like it will be coming up as a phase 3 multi-center trial soon. I'm hoping to jump on it if I can. It is going to be an 8 week or a 12 week randomized trial. No Riba or Inf. Any thoughts on SVR in trials only lasting 8 weeks?
Phase II SVR results I've seen for my genotype (1a, non-cirrotic) are 93% 12 weeks, 96% for 24 weeks. Also, if this didn't work for me, since I would no longer be treatment naive, would this be a disadvantage?
Yep...it is worthless
I followed that trial on clinicaltrials.gov for months and pounced the day after it said it was open for recruiting. Sent in the form to Sylogent. It looked to me like everything was okay and that I was a good candidate.
Never heard anything from anyone. So I emailed Sylogent and was told that recruiting was closed!
Today I talked with some study centers in New York that are working with Janssen, and they told me that these trials are very competitive and no one is getting in who isn't already on a study center list. It ain't fair, but "Es lo que hay" ("It's what there is" [old Spanish saying]).
Since the trials are conducted as a business, the attitude of a lot of the people involved in them is strictly business-like, and this is the way business is conducted, I guess. Like 'finders keepers, losers weepers".
Someone at a study center told me that you need to find out way in advance who's doing the trial, talk to them on the phone, try to go see them, send them test results, get on their list of trial candidates, maybe even pay a coupla hundred bucks to see an MD and become an official patient there, and then call them all the time so they won't forget you.
I hate to be cynical, but I think any idea of these trials being conducted in a democratic way on a level playing field are out the window.
One thing's for sure: clinicaltrials.gov is worthless.
Mike
Maybe thats a good sign for you. They could have forwarded your info to your trial center who would then call you. Hope thats the case.
At least you got a response. I have heard nothing from them. I bet tens of thousands of people applied for that trial, so being accepted would be like winning the lottery.
FYI for all who applied online for this....I just had a response from Sylogent (the org that handles recruitment). This was the message: "Thank you for visiting www.ClinicalTrials.gov and expressing interest in a clinical trial for NCT02114177. Unfortunately, the sponsors of that trial have informed us that enrollment for the study has closed and will not be accepting new participants. This information will be updated on www.ClinicalTrials.gov shortly."
No doctor right now. We travel full-time and I haven't had a regular doc for many years....
I filled out the form too....but no call. I suspect the easy to fill positions are already taken. This is what I have been hearing from a couple of trial centers I've been in contact with, that for many of the upcoming trials for these drugs which have already been tested in trials, that the FDA is wanting more trial data for select "people groups", i.e. not caucasian women or men. Don't know if that is happening with this one.
Keep us posted if you get a call.
Hi Marcy,
This the same Tx regimen that I completed in early April with a physician participating in the COSMOS trial. I also am not Tx naïve, but have mild cirrhosis. I've been UND since week 4 and hopefully will be SVR when I test again in approximately 2 weeks.
Being cirrhotic, I would not be eligible for the Optimist-1 trial. Certainly didn't miss taking Ribavirin (much less inf), which seems to have support from the final COSMOS data. The Genotype 1, ILB 28 CT scores for F0-F2 were 100% SVR from the COSMOS data, with or without Ribavirin for 12 weeks. Impressive, although the trial size was small.
John
-- Edited by Gator Man on Wednesday 28th of May 2014 09:15:25 PM
The trial is now in the recruitment phase. I filled out the initial form yesterday 5/27/14 at 7:30PM EST. Here is a link to it: http://clinicaltrials.gov/ct2/show/NCT02114177?term=NCT02114177&rank=1
I am now anxiously awaiting a call--hoping and praying...
Hi Marcy,
Best of luck on getting into your trial. As far as I know, that will be the first one to study the effectiveness of an 8 week treatment using the S/O combo. Also the first not to use ribavirin in any of the treatment arms. Looks like re-treatment with Sovaldi won't be a problem down the road, though you'll need to combine it with a different class DAA.
wayne
Hi all,
Been keeping my eye out and this trial looks like it will be coming up as a phase 3 multi-center trial soon. I'm hoping to jump on it if I can. It is going to be an 8 week or a 12 week randomized trial. No Riba or Inf. Any thoughts on SVR in trials only lasting 8 weeks?
Phase II SVR results I've seen for my genotype (1a, non-cirrotic) are 93% 12 weeks, 96% for 24 weeks. Also, if this didn't work for me, since I would no longer be treatment naive, would this be a disadvantage?
Thanks to all!