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I was turned down for Vertex trial
This is just to let everybody know, I'm not going to be in the Vertex clinical trial. I was turned down. Not because of my labs, or any real GOOD reason. But, because of this stupid records issue. I could have handled the disappointment better if if was because of a valid medical reason. But, because this doctor, who is no longer in the area, did not keep documented enough records while I was on the Peg-Intron, they turned me down. Never mind that I had great records from my current doctor, using the Infergen. The time frame that I was using the Peg-Intron was back in 2001-2003 time frame. I got everything from his office and unfortunately, he did not document all of my follow-up visits. I did come up with the record from when he prescribed the Peg-Intron, the 6 month refill order and all the PCR and labs and pharmacy records, but that was not good enough.
ANOTHER NEWS FLASH: I am no longer a dual genotype! After all these years of being a 1A/1B, I am now just testing as a 1A. That was surprising news that all my treatments managed to knock out 1 genotype, but not the other. I guess the 1A was stronger in my body. My current viral load isn't as high as it's been in the past, at this 10 mon. post treatment time, it's only 2,250,000. In the past, it's been a lot higher.
The study nurse told me that I'll probably have this problem in the future with any clinical trials that use Peg-Intron or Pegasys, since they'd insist on having those records. If they come up with a trial using the Infergen, then, I won't have a problem.
I'm sort of disappointed because I really wanted to get rid of this once and for all and I thought that the Vertex drug would do it. But, maybe it still will, just not until it's FDA approved in 5-6 years.
Susan
ANOTHER NEWS FLASH: I am no longer a dual genotype! After all these years of being a 1A/1B, I am now just testing as a 1A. That was surprising news that all my treatments managed to knock out 1 genotype, but not the other. I guess the 1A was stronger in my body. My current viral load isn't as high as it's been in the past, at this 10 mon. post treatment time, it's only 2,250,000. In the past, it's been a lot higher.
The study nurse told me that I'll probably have this problem in the future with any clinical trials that use Peg-Intron or Pegasys, since they'd insist on having those records. If they come up with a trial using the Infergen, then, I won't have a problem.
I'm sort of disappointed because I really wanted to get rid of this once and for all and I thought that the Vertex drug would do it. But, maybe it still will, just not until it's FDA approved in 5-6 years.
Susan
I still plan on going on Wed. My appt. is at 12:30. Any possibility of your getting there to the office slightly earlier? I don't want to be suggesting something that will inconvenience you. I just don't want to miss each other. I'll be traveling over with my friend. She keeps me company on the drive. We normally go over to Cracker Barrel there in Lakeland after our appt.
Susan
Susan
Next week we have lots to talk about. My first Gastro kept no records also-at least we have smartened up at this stage by securing our records. I have 2 5" binders full, so I can imagine what you have.
I am so sorry that you didn't get into the trial-but try to look at it as positive as possible-maybe it wasn't meant to be.
I have done the rounds at Shands now, seeing all doctors needed. I also received bad news. It appears that the cryoglobulin has resulted into another disease, which the only cure for is chemo. So, I have to live with the Neuropathy as nothing can be done.
I am riding that roller coaster of emotions again-but this time, their appears to be no good end. I will fill you in next week in Lakeland. I hope you are still going?
If anyone else post treatment or while on treatment has had a balance or falling problem, I can probably pass on some more info if needed.
I am so sorry that you didn't get into the trial-but try to look at it as positive as possible-maybe it wasn't meant to be.
I have done the rounds at Shands now, seeing all doctors needed. I also received bad news. It appears that the cryoglobulin has resulted into another disease, which the only cure for is chemo. So, I have to live with the Neuropathy as nothing can be done.
I am riding that roller coaster of emotions again-but this time, their appears to be no good end. I will fill you in next week in Lakeland. I hope you are still going?
If anyone else post treatment or while on treatment has had a balance or falling problem, I can probably pass on some more info if needed.
I am very sorry to hear about your problems. I hope you can resolve them.
Perhaps you can contact the lab that did the PCRs. It is the PCRs that show the treatment failure that are the most important thing.
Perhaps you can contact the lab that did the PCRs. It is the PCRs that show the treatment failure that are the most important thing.
Wow that is so incredibly unfair I can't stand it and don't understand it. Have you looked into any of the other studies? I'm just so sad for you right now I don't even know what so say - which isn't much like me.
Now I want to go and get retested and find out I'm no longer a dual genotype either!!!!!!!!!!!!! I do have to go do the next PCR but I've been putting it off cause of personal problems. At least it's one down one to go right?
Oh honey, I just do not have the words to say how sorry I am. All cause of some stupid doctor being lazy. Man oh man is there any way you can find him? Maybe there are more records written somewhere than what was put into the chart when it was typed out by a transcriptionist?
You know what I mean?
Now I want to go and get retested and find out I'm no longer a dual genotype either!!!!!!!!!!!!! I do have to go do the next PCR but I've been putting it off cause of personal problems. At least it's one down one to go right?
Oh honey, I just do not have the words to say how sorry I am. All cause of some stupid doctor being lazy. Man oh man is there any way you can find him? Maybe there are more records written somewhere than what was put into the chart when it was typed out by a transcriptionist?
You know what I mean?
I am so sorry you were turned down for such an insignificant thing. When my doctor copied all of his records for me to take to the new hepatologist in Dallas, there were NO post treament records. No doctor's comments at all except those one or two worders on my labs "seems relapse" "see hemotologist"... such as that. None or what I would consider clinical notes. I wonder how that would factor into my gettiing in to a trial.
Yesterday I called the trial recruiter in Dallas. I had emailed her 3 times through the Vertex trial information site. The first time I never heard back so a few days later I sent another email to the same addy. Turned out I had sent it to Colorado instead of Dallas and that recruiter responded (that Colorado was closed). I emailed again to Dallas and never heard back. Yesterday I called and spoke with the Dallas recruiter. She never received my email. That makes me wonder if the whole link is screwed up. http://www.clinicaltrials.gov/ct/show/NCT00420784?order=1
She said Dallas was closed too -- they only had 8 slots open. She asked if I was a nonresponder or a relapser. They had some other studies for nonresponders but none coming up for relapsers.
Good luck to you Susan. Maybe you need a longer breadk anyway.
frijole
Yesterday I called the trial recruiter in Dallas. I had emailed her 3 times through the Vertex trial information site. The first time I never heard back so a few days later I sent another email to the same addy. Turned out I had sent it to Colorado instead of Dallas and that recruiter responded (that Colorado was closed). I emailed again to Dallas and never heard back. Yesterday I called and spoke with the Dallas recruiter. She never received my email. That makes me wonder if the whole link is screwed up. http://www.clinicaltrials.gov/ct/show/NCT00420784?order=1
She said Dallas was closed too -- they only had 8 slots open. She asked if I was a nonresponder or a relapser. They had some other studies for nonresponders but none coming up for relapsers.
Good luck to you Susan. Maybe you need a longer breadk anyway.
frijole
I'm so sorry to hear that, Susan. You might not even want to think much more today about other trial options after having gotten today's news, (so very disappointing, I know), but have you given any thought to the HCV 796 trials that are now recruiting? If so, and if someone from Duke or UNC gets in touch with you or you can get through to them, you might want to inquire about the possibility of the 796 trial, too (just echoing what some others have suggested).
If you are interested, Dr. K Patel would be doc at Duke for HCV 796 at 919 681-4044. Janet Jessick is his PA (very nice).
Katie Mullen (who is VX coordinator) is at a new number 919-681-9479. You can also call the central research number at Duke at 1-866-704-4673 (just giving you more phone numbers.
Of interest - UNC is not listed anymore on the clinicaltrials dot gov as a PROVE3 site. (?? anyone know why? - not me ) But anyhow, they ARE listed for the HCV 796 and are now recruiting.
UNC Gastro Division is 919-966-2511.
UNC might request a referral from your primary or your GI before they see you (possibly before they even speak to you.)
Best of luck to you.
If you are interested, Dr. K Patel would be doc at Duke for HCV 796 at 919 681-4044. Janet Jessick is his PA (very nice).
Katie Mullen (who is VX coordinator) is at a new number 919-681-9479. You can also call the central research number at Duke at 1-866-704-4673 (just giving you more phone numbers.
Of interest - UNC is not listed anymore on the clinicaltrials dot gov as a PROVE3 site. (?? anyone know why? - not me ) But anyhow, they ARE listed for the HCV 796 and are now recruiting.
UNC Gastro Division is 919-966-2511.
UNC might request a referral from your primary or your GI before they see you (possibly before they even speak to you.)
Best of luck to you.
Dear Liv,
I live in Florida. I sent an email to that address that Jim listed. I don't know if it will do any good, or not.
Thanks,
Susan
I live in Florida. I sent an email to that address that Jim listed. I don't know if it will do any good, or not.
Thanks,
Susan
Hi: Sorry you were turned down for a technicality it seems. What state do you live in? You could try to get in touch with Catee Mullen, PAC an assistant to Dr. McHutchinson. She was in charge of the 950 trials at Duke Univ. Phone # 919 - 668 - 8088. Also Univ. of N.C. at Chapel Hill was conducting a trial last year but you could call and ask. Phone # 919 - 966 - 2516 then follow the prompts, I think you press # 6 on touch tone phone when asked. That connects you to clinical trials coordinator I believe. I also have a # for Vertex in Cambridge, Mass. that I believe will give you a list of trial locations and starting dates but you probably have already been in touch with them. Ph. # 617 - 577 - 6602. Best of luck and let us know how you make out.
Susan,
Sorry to hear you were turned down. I agree the reason doesn't seem right as you appear to have qualified otherwise and considering you do have at least some documentation. Only suggestion is to see if you can contact the retired doctor and if he's an agreeable sort, maybe he might either have archived some of his records or possibly he would piece a document together for you filling in the missing blanks.
Other than that, you might want to contact Hutchinson directly, outlining your treatment history as well as your current situation and see if he can be of some help. Considering your seven failed treatments, if anyone deserves a break on this it's you. His email is:***@****
I also flagged "Liv" because as a patient of Dr. McHutchinson, she might be able to help some.
All the best,
-- Jim
Sorry to hear you were turned down. I agree the reason doesn't seem right as you appear to have qualified otherwise and considering you do have at least some documentation. Only suggestion is to see if you can contact the retired doctor and if he's an agreeable sort, maybe he might either have archived some of his records or possibly he would piece a document together for you filling in the missing blanks.
Other than that, you might want to contact Hutchinson directly, outlining your treatment history as well as your current situation and see if he can be of some help. Considering your seven failed treatments, if anyone deserves a break on this it's you. His email is:***@****
I also flagged "Liv" because as a patient of Dr. McHutchinson, she might be able to help some.
All the best,
-- Jim
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