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
tkflex36 said
Jan 4, 2016
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.
Great news, you're one giant step closer! Kick that dragon's ***!
Be well, eat well and take care,
Linux
wmlj1960 said
Dec 28, 2015
That's good news Rich! Keep us up to date and you enjoy the next 3 days also.
2016 will be your 'Dragon Slaying' year.
Tig said
Dec 28, 2015
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!
tkflex36 said
Dec 28, 2015
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!
Greg D said
Dec 22, 2015
Happy for you Rich way to go! All the very best and please keep in touch, look forward to following your journey!
bubble said
Dec 22, 2015
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.
tkflex36 said
Dec 22, 2015
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
Canuck said
Dec 22, 2015
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
Tig said
Dec 21, 2015
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!
Flower Child said
Dec 21, 2015
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.
MechanicMike said
Dec 21, 2015
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!
tkflex36 said
Dec 21, 2015
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!
wmlj1960 said
Dec 16, 2015
That's good news Rich. It looks like your getting all stocked up for that pioneering expedition. Happy trails!
tkflex36 said
Dec 16, 2015
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!
Tig said
Dec 16, 2015
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!
bubble said
Dec 16, 2015
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.
tkflex36 said
Dec 16, 2015
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.
bubble said
Dec 2, 2015
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 !
tkflex36 said
Dec 2, 2015
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
wmlj1960 said
Dec 1, 2015
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.
freesoul said
Dec 1, 2015
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 !!!
Tig said
Dec 1, 2015
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
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
tkflex36 said
Dec 1, 2015
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
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
Congrats tkflex36,
Great news, you're one giant step closer! Kick that dragon's ***!
Be well, eat well and take care,
Linux
That's good news Rich! Keep us up to date and you enjoy the next 3 days also.
2016 will be your 'Dragon Slaying' year.
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!
Happy for you Rich way to go! All the very best and please keep in touch, look forward to following your journey!
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.
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
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!
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.
That's good news Rich. It looks like your getting all stocked up for that pioneering expedition. Happy trails!
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!
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.
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 !
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.
Best of luck !!!
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
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