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Hep C Discussion Forum -> Clinical Trial Participants -> Optimist-1 Janssen Sofosbusvir 400 mg and Simeprevir 150 mg upcoming trial
Post Info TOPIC: Optimist-1 Janssen Sofosbusvir 400 mg and Simeprevir 150 mg upcoming trial
Milliganus


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RE: Optimist-1 Janssen Sofosbusvir 400 mg and Simeprevir 150 mg upcoming trial
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Yep...it is worthless



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND
Mike716


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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



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70-year-old male. Diagnosed HCV+ in 2008 with geno 1b. 2008 biopsy: A2/F1. Now F2+, with platelets down. No insurance, so applied for Sovaldi and Olysio patient assistance. Trying to get into a trial for 5 years with no luck.
Milliganus


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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.



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND
skewedButNotBroken


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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. cry



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Diag. with hep c in 1992; A3:F2;  GT 1a; IL28B CT; VL 900k, ALT 150, AST 100 on 8/5/2014; SOT 9/5/2014  S/O ---VL 127 after 6 days; VL detected on day 18 but < 15.; --> UND @ EOT+ 1 year SVR!
Milliganus


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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

 

 



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND
Milliganus


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No doctor right now.  We travel full-time and I haven't had a regular doc for many years....



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND
tgcd78


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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?

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Female 35, Genotype 1a - Completed the OPTIMIST clinical trial - sovalid (400mg)/Olysio (150mg) |  Starting VL 8mil, 3 day VL 300, 1 week viral load UND

SVR - November 14th. 2014!!!
Milliganus


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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.

 



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND
Gator Man


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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

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Geno 1b, compensated cirrhotic, 54 yo, prior null responder. Pre tx VL approx 595,000, tx with Sovaldi/Olysio (no Riba) started 1/8/14. VL 40 @ 2 weeks, UND @ 4 weeks. Still UND @ EOT + 1 year.

Gator Man SVR12, Dragon 0, Final Score.
skewedButNotBroken


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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...



__________________

Diag. with hep c in 1992; A3:F2;  GT 1a; IL28B CT; VL 900k, ALT 150, AST 100 on 8/5/2014; SOT 9/5/2014  S/O ---VL 127 after 6 days; VL detected on day 18 but < 15.; --> UND @ EOT+ 1 year SVR!
OldenSlow


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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



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66 y/o male - Geno 1b - F4 cirrhotic dx 2001 - 16 wk treatment w/ Sovaldi/Olysio/Riba - Und @ EOT+24 SVR

 
Milliganus


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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!



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND
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