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Hep C Discussion Forum -> Clinical Trial Participants -> Finally got accepted for trial!
Post Info TOPIC: Finally got accepted for trial!
Linuxter


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Finally got accepted for trial!
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You'll do fine tkflex36, try to keep a positive attitude, I know that you do anyway. (You're obviously NOT one of those 'Cynical Trial Participants' :eyeroll).

Whatever you get will be kickin' that dragon's tail, I see SVR in your near future, we're right here rootin' ya on.

Keep us posted!

 

Linux



-- Edited by Linuxter on Tuesday 5th of January 2016 04:07:41 AM

__________________

63yy,HCV,2b,F3-A1, Sof/Riba,12wks Tx   SOT: 1/20/16, HCV-RNA 9,816,581, ALT 56, Hb 14.6

4wk: HCV-RNA <15 Detected, ALT 15, AST 17, Hb 13.6 EOT: 4/12/16, ALT 18 , Hb 12.9176a2f85d05d9c965eafe199f2ba9ba5.jpg SVR Achieved 7/8/16

 
tkflex36


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36 more hours to go! I've really found myself going back and forth over which of the meds I'll get (duel or triple). I know it's not up to me but being a 3a I'm just really nervous if I only get 8 weeks tx. I was actually arguing with someone on another forum that velpatasvir was just as good as daklinza, but I guess everyone has their own opinion.

__________________

36 yo M, first dia in 2002, geno 3A, TX naive, starting trial of sof/vel 12 weeks on 1/6/2016

VL on 12/21/15- 507,000

12 week EOT 3/30/16, VL-UNDETECTED ALT-23, AST-24

24 wk post tx  10/16 VL-UNDETECTED! ALT-16, AST-18

SVR24+all LFTs normal=1 DEAD Dragon!

 

Don't stop fighting til the dragon is DEAD!
Linuxter


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Congrats tkflex36,

Great news, you're one giant step closer! Kick that dragon's ***!

 

Be well, eat well and take care,

Linux



__________________

63yy,HCV,2b,F3-A1, Sof/Riba,12wks Tx   SOT: 1/20/16, HCV-RNA 9,816,581, ALT 56, Hb 14.6

4wk: HCV-RNA <15 Detected, ALT 15, AST 17, Hb 13.6 EOT: 4/12/16, ALT 18 , Hb 12.9176a2f85d05d9c965eafe199f2ba9ba5.jpg SVR Achieved 7/8/16

 
wmlj1960


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That's good news Rich! Keep us up to date and you enjoy the next 3 days also. biggrin

2016 will be your 'Dragon Slaying' year.



__________________

60 yo, geno 1a, Dx 1994 HCV-HIV co-inf, Dx 2013 decompensated cirrhosis
Tx #1 - 24wks Sov+Riba /SOT 7-24-2014/UND@EOT/DETECTED@EOT+16 wks
Tx #2 - 24wks Harvoni /SOT 7-25-2015/UND@EOT,+12,+24,+52 = SVR

Mike

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Tig


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Hey Rich,

That's great news, congrats on the acceptance! You'll have the best care and attention to detail is a big plus. Let us know how things progress. Good luck!



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Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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tkflex36


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Just heard back from the trial director. All my screening tests came back and they say it all looks ok. I will be getting the meds in 9 days. I was hoping for this week but it's definitely happening next week! I'll know on day 1 which of the gilead combos I'll be on, and I will post pre tx bloods results as soon as I know! Enjoy the rest of 2015 everyone!

__________________

36 yo M, first dia in 2002, geno 3A, TX naive, starting trial of sof/vel 12 weeks on 1/6/2016

VL on 12/21/15- 507,000

12 week EOT 3/30/16, VL-UNDETECTED ALT-23, AST-24

24 wk post tx  10/16 VL-UNDETECTED! ALT-16, AST-18

SVR24+all LFTs normal=1 DEAD Dragon!

 

Don't stop fighting til the dragon is DEAD!
Greg D


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Happy for you Rich way to go! All the very best and please keep in touch, look forward to following your journey!



__________________

60 yo (2013), genotype 2b, started 28 week tx Sept.14, 2013. Triple Therapy (ribavirin, victrelis, peginterferon), VL 235k prior to tx, UND right through. EOT March 29, 2014. EOT24 Sept. 15, 2014 and EOT + ONE YEAR April 1, 2015 UND.... SVR!

 
bubble


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Rich: Your in my general area. I take my wife to U-Penn./neurological dept. 1st hospital built in America!  Even years ago I took all my hounds to their Vetenary Hospital. Cutting edge tech. no locals ever heard of. They just merged with Jefferson University Hospital so they are the place to go! Lots of eager interns, fellowships, and very well experienced doctors. You are in good hands. Huge network. It should be an honnor.  I am glad to read you made the grade today. Way to go. Looking forward to reading from you about the trials. Good Luck buddy.



__________________

60 yrs. Geno1b 2001. 9mil. VL. �Failed Post Riba/Peg tx. 2006 46 weeks. Diagnosed 1A 2015(?) F3 fibr. 225k VL. Vikera/Riba 12 weeks 3/20/2015. "Undetected" start to finish. Undetected 1yr post tx.
tkflex36


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Thanks for the encouragement everyone! And canuck, I don't know if I can answer your question as to how to find the place in your city, but even as of yesterday my location which is Philadelphia PA still showed up as "not yet recruiting" on the nct site. Maybe you can call the places you think it might be going on and try to pin down the location. Hope that helps, and wish you all the best! Tk

__________________

36 yo M, first dia in 2002, geno 3A, TX naive, starting trial of sof/vel 12 weeks on 1/6/2016

VL on 12/21/15- 507,000

12 week EOT 3/30/16, VL-UNDETECTED ALT-23, AST-24

24 wk post tx  10/16 VL-UNDETECTED! ALT-16, AST-18

SVR24+all LFTs normal=1 DEAD Dragon!

 

Don't stop fighting til the dragon is DEAD!
Canuck


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I'LL HAVE WHAT HE'S HAVING PLEASE!

Good for you, getting into NCT 02607800-POLARIS 3 trial.

I had already been scouring this trial (to try to find out WHO/WHERE the one (single) "study location" is for Vancouver, BC, Canada. 

"Study locations" are often not shown on NCT's. Canadian locations (listed on this NCT) - Alberta, Ontario, Quebec nor BC  - are "not recruiting yet", but I wish to know WHO in Vancouver will be recruiting, to ensure I have positioned myself correctly for it. If I have not, then I will make sure I am in the right place/position to be considered for entry into this study

Can anyone tell me how to figure out WHO is the Vancouver study location please - there are about only 4 places in Vancouver who carry out trials I believe? 

GT3a, TN, high load, F3 - 40 +++ years chronic, only recently diagnosed - almost all "pre-trial" entry work-ups have already been completed - should be good to go by Apr/May 2016.

Canuck

 

 



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)
Tig


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Hey Rich,

Congratulations for getting the ball rolling! This is the beginning of the end for your pet Dragon, may it die in flames......  (That's serious drama there, lol!)   Good luck buddy!



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Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Flower Child


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Congrats getting on this trial!  It looks promising!  

I may know someone who is also starting this trial soon.  If so, will see if she can join the forum.  



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~Rebecca

Support for: 52yo, Geno 3a, F1. Tx: Dak/Sov-12 wks SOT: Dec 2015. VL 1mill at SOT

VL~58 - taken 5 days after start; VL UND @ 2 wks; UND 1 mos; UND EOT
MechanicMike


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Hi Rich, it's great to hear that you're getting treatment! I remember chatting with you when things didn't look promising. Proud of you for sticking with it. Now you'll be looking at the dragon in your rear-view mirror in no time! What a great Christmas present! Congrats man!

__________________

GT 3a, 56 yo male, diagnosed 3/15/15, infected 23+ years, F3, starting VL 10+ MIL.  ALT 86/AST 45.  Started 24 wks Sov/Riba 4/13/15.  5/14/15 thru 8/31/15 Undetected.  ALT 19, AST 14.  12/31/15:  SVR12!!!  01/06/17:  1 Year SVR (WOOT!!!)
tkflex36


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So I went for the screening process, and after about 12 tunes of blood, an ekg, a urine test, and a bunch of questions I was done! Only took about an hour. I should know the results by the end of the week and if everything goes good should be on the meds by middle of next week. She did say if I was cirrhosis I couldn't participate in this study but there is a different study with the same meds that I can do if that's the case. She also said the 20 people who participated the phase 2 study with the same meds across all Genos all achieved svr24! I just can't wait to get the party started. P.s. the university of pennsylvania hospital is one of the most impressive medical complexes I have ever seen!

__________________

36 yo M, first dia in 2002, geno 3A, TX naive, starting trial of sof/vel 12 weeks on 1/6/2016

VL on 12/21/15- 507,000

12 week EOT 3/30/16, VL-UNDETECTED ALT-23, AST-24

24 wk post tx  10/16 VL-UNDETECTED! ALT-16, AST-18

SVR24+all LFTs normal=1 DEAD Dragon!

 

Don't stop fighting til the dragon is DEAD!
wmlj1960


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That's good news Rich. It looks like your getting all stocked up for that pioneering expedition. Happy trails! smile



__________________

60 yo, geno 1a, Dx 1994 HCV-HIV co-inf, Dx 2013 decompensated cirrhosis
Tx #1 - 24wks Sov+Riba /SOT 7-24-2014/UND@EOT/DETECTED@EOT+16 wks
Tx #2 - 24wks Harvoni /SOT 7-25-2015/UND@EOT,+12,+24,+52 = SVR

Mike

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tkflex36


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I won't find out which arm I will be in until the day 1 visit, which they said would be like 3 weeks from screening. But frankly I'm good with either the 8 or 12 week arms, but kinda hoping for the 8 week triple K.O. meds! They already have all my test results from 10/14, which were the last labs I've had. There are going to be 800 people in this study but only about 6 people at my location which is at University of Penn in Philadelphia. I just noticed an attachment in the email which was a 28 page consent form which tells me everything about the trial. Since it is an open study I hope I have access to the results of blood work as I go through it, that I'll ask about. Tig, I already have the horses hitched to the wagon to go with the hat, I'm ready to hit the trail!

__________________

36 yo M, first dia in 2002, geno 3A, TX naive, starting trial of sof/vel 12 weeks on 1/6/2016

VL on 12/21/15- 507,000

12 week EOT 3/30/16, VL-UNDETECTED ALT-23, AST-24

24 wk post tx  10/16 VL-UNDETECTED! ALT-16, AST-18

SVR24+all LFTs normal=1 DEAD Dragon!

 

Don't stop fighting til the dragon is DEAD!
Tig


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That's good news! They will ask you a thousand questions, probably the same ones you have answered already. It may take more than one appointment too. They will confirm that you meet their requirements and once qualified, will explain what's expected of you and what they will provide. Once all the t's are crossed and i's dotted, they will do the needed testing to confirm genotype, viral load and a dozen other things they need to know.

If you have any test results from previous appointments, you might want to throw them in a folder and take them with you. I missed out on a trial because I didn't keep copies from years back. Always ask for copies of your lab work. They may not give them to you because this is a study, but it's worth asking about. 

Clinical trials require much more testing and attention to detail than does an established, approved protocol. You are paving the way to a new treatment, so they want to know the smallest details obtainable. Get used to lots of lab tests, but it's an important part of the trial procss. Dust off your Pioneer hat, you'll be wearing it for awhile! Good luck!

 



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Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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bubble


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I am sure you will make it. 3a and never treated makes you a prime canidate for the arm.  Let us know of this interesting advancement. Let see: 56 weeks, 24 weeks, 12 weeks, 8 weeks, Hopefully soon it will be a one week cure!  Amazing !!!  Good Luck Rich.



__________________

60 yrs. Geno1b 2001. 9mil. VL. �Failed Post Riba/Peg tx. 2006 46 weeks. Diagnosed 1A 2015(?) F3 fibr. 225k VL. Vikera/Riba 12 weeks 3/20/2015. "Undetected" start to finish. Undetected 1yr post tx.
tkflex36


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Just got an email from the trial director, I am going in for the screening visit this Mon! Anyone have any knowledge of what all takes place at a trial screening? They said it will take 90 min.

__________________

36 yo M, first dia in 2002, geno 3A, TX naive, starting trial of sof/vel 12 weeks on 1/6/2016

VL on 12/21/15- 507,000

12 week EOT 3/30/16, VL-UNDETECTED ALT-23, AST-24

24 wk post tx  10/16 VL-UNDETECTED! ALT-16, AST-18

SVR24+all LFTs normal=1 DEAD Dragon!

 

Don't stop fighting til the dragon is DEAD!
bubble


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Interesting Rich, and thanks for going for it and staying with us on it. This is the one pan-genotype "cure all" pill Gilead is pushing now. Their staying atop of Abbvie. Looks like an 8 week. I have seen stuff on a 4 week too.

Amazes me how much grit and determination both companies bring on so fast now. This isnt like it was 9 years ago. Good luck to you !



__________________

60 yrs. Geno1b 2001. 9mil. VL. �Failed Post Riba/Peg tx. 2006 46 weeks. Diagnosed 1A 2015(?) F3 fibr. 225k VL. Vikera/Riba 12 weeks 3/20/2015. "Undetected" start to finish. Undetected 1yr post tx.
tkflex36


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Thanks for the kind words everyone! Im really excited to finally rid myself of this monster and to be a part of bringing these new meds forward into the public market. I know the geno 3's really needed this. I will definitely keep everyone up to date as things progress in the next few weeks! TK

__________________

36 yo M, first dia in 2002, geno 3A, TX naive, starting trial of sof/vel 12 weeks on 1/6/2016

VL on 12/21/15- 507,000

12 week EOT 3/30/16, VL-UNDETECTED ALT-23, AST-24

24 wk post tx  10/16 VL-UNDETECTED! ALT-16, AST-18

SVR24+all LFTs normal=1 DEAD Dragon!

 

Don't stop fighting til the dragon is DEAD!
wmlj1960


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That's good news Rich and I know you are happy to FINALLY get the show on the road. And we will be watching your progress closely as you progress with this trial so stay in touch.



__________________

60 yo, geno 1a, Dx 1994 HCV-HIV co-inf, Dx 2013 decompensated cirrhosis
Tx #1 - 24wks Sov+Riba /SOT 7-24-2014/UND@EOT/DETECTED@EOT+16 wks
Tx #2 - 24wks Harvoni /SOT 7-25-2015/UND@EOT,+12,+24,+52 = SVR

Mike

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freesoul


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Yes!!!! So happy for you. Clinical trials can rock for those of us with no other options...esp the Phase 3 ones, as you pretty much know the stuff works by that point. I am in one right now and it is frankly giving me my life back.

Best of luck !!!

__________________

38 yr old, Fib stage 1, last VL 5.3 mil - Cured by Abbvie clinical trial

Genotype 1a, Dx 2010 but probably had for 20 yrs+ 
Tig


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Hey Rich,

You've hit pay dirt on this one buddy! The reports are very exciting and rates of success are high. If I'm reading it right, the arm for treatment naive is an 8 week course of Sov/Vel/GS9857 or a 12 week dual w/Sovaldi & Velpatasvir (Polaris 2). The Polaris 1 (Tx experienced) is 12 weeks of the triple protocol. This should do the trick! Good luck...

Here's the clinical trial for the tx experienced arm: Polaris 1

https://clinicaltrials.gov/ct2/show/NCT02607735



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Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Cinnamon Girl


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H Rich, that`s very good news!

I had a look at the clinical trials website and this looks like the trial you`ve been accepted for...

https://clinicaltrials.gov/ct2/show?term=Sofosbuvir+Velpatasvir+GS9857&rank=3

This should be a very effective combnation, from the data we`ve seen so far.

Please keep us updated, we`re very interested in clinical trials, and I`m sure you`ll be hearing from others.

Wishing you all the best of luck!






-- Edited by Cinnamon Girl on Tuesday 1st of December 2015 05:34:43 PM



__________________

Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
tkflex36


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I haven't posted in here for awhile, frankly I was disappointed in the system after getting rx'd sof/riba 24 wks and after fighting with ins for 8 months even with support path couldn't get the meds. But 10 days ago I got a call from University of Penn asking if I was interested in a all gilliad phase 3 trial, yes please! So I should be going next week for screening and start meds within 30 days. Trial # on clinicaltrials.government is nts02607800. This is a worldwide open label random study with 2 arms, either sof/vel for 12 weeks or sof/vel/gs9857 for 8 weeks. It's open to ALL Genos as these new meds can treat everyone in a shorter time span. I'm a 3a. There are some restrictions such as no prior treatment with DAA's, but there's not many. So for anyone who thinks this study could be of use, maybe now is the time as there will be thousands of participants all over, and according to CT.gov it's not even recruiting yet, but I've been called aND put on the list so obviously they are starting the process. Please feel free to chime in on opinions of these meds or trials in general as this will be my 1st time with tx, and I've had this for at least 15 years! Much love everyone, TK

__________________

36 yo M, first dia in 2002, geno 3A, TX naive, starting trial of sof/vel 12 weeks on 1/6/2016

VL on 12/21/15- 507,000

12 week EOT 3/30/16, VL-UNDETECTED ALT-23, AST-24

24 wk post tx  10/16 VL-UNDETECTED! ALT-16, AST-18

SVR24+all LFTs normal=1 DEAD Dragon!

 

Don't stop fighting til the dragon is DEAD!
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