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Avatar universal

Considering Clincal Trials...

Where do I start?

I found this website doing a search for "How to tell your employer you have hepatitis C." I was awed by the questions and real responses I saw posted to so many questions that I decided to setup an account.

I deny that this is happening to me. I found out 1 year ago today, went through the anger/depression/denial stage. I received a blood transfusion when I was born.  My mother insisted that I do not receive donor blood (at that time HIV was a big scare); however, the nurse at the hospital ensured her I would be safe. Basically, the blood transfusion that saved my life when I was born is now slowly killing me. I am trying to deal with this disease the best I can. I just want my life back. I feel so dirty and ashamed to tell people the real reason I am sick. I know how people will look at it; I remember how I viewed it the moment I found out.

I met a wonderful doctor who heads various HepC trials and other medical research at the university hospital. We discussed treatment now and/or later and the pros/cons. All I remember her saying is "if the treatment doesnt work the first time...the virus will mutate and be harder to treat later down the road."  Soo..I am considering fighting it as hard as I can.

There is a clincal trial going on in my area for genotype 1 patients who have never been treated before. You receive basic interferon and ribiveron (spelling?) plus the chance to receive a new drug. It sounds appealing yet so scary.

In one way the pharmaceutical company uses you to test the drug...not treat the patient..SCARY THOUGHT. On the same token, I imagine you must follow strict guidelines as to how else to take care of yourself (meaning if you are sick you can only take certain med as to not mess with the study)

On the other side...what if?!?! it might just work...

Has anyone ever participated in a clinical trial?
I
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Avatar universal
No I have not heard much about it. I know it was SUPPOSED to start in July but it kept getting delayed due to FDA things and Roche. I think it might start November?!? Do you know what R1626 means? top secret coding?!?!
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Avatar universal
The trial coordinator at my clinic emailed me about this trial last month, called it R1626 . She said they thought they would start recruiting at the end of November. I haven't heard anything more from her though. Did your doc mention anything about the timing of the study? I am hoping that nothing starts happening until after the holidays. I am in MInnesota.
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Avatar universal
Well done---to the favorite list it goes. jerry
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Avatar universal
I truely appreciate the time you took to write the list of questions for the clincal trial. May God bless you for your kindness!
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Avatar universal
Ok so that's the study you want to go into huh? There are a lot of details missing from the information provided there, so here's a general laundry list of questions you might want to start out with:

1. What is this drug called? They refer to it as simply "HCV polymerase inhibitor pro-drug". Is that its official name?

2. This drug is in phase II trials. That means phase I trials have already been completed or are currently underway. What are the details concerning the phase I trials? How long was it dosed? At what dosages? How effective was it at eradicating the virus? How quickly did viral rebound occur? What did the toxicity and side effect profile look like? There was another polymerase inhibitor tested recently that had bad liver toxicity effects if memory serves. etc...

3. In the current phase II trial there are seven groups. Do not assume that all of the groups are randomly assigned equally. Sometimes more people are put into certain groups than in others. In order for you to know your true odds of being assigned any particular group (especially the control group which will not receive the research drug). So your odds of being assigned to any one group are directly affected by the breakdown of the various group populations (being an accountant this should be easily understood). Make sure you ferret this info out with certainly too, the trial info I was given (both verbally and in our consent form) had the odds incorrectly stated. There was actually a significantly higher chance of being assigned to the placebo group than was indicated in our *official* consent form, and our study burse merely parroted what was in there (because it had outdated info in it).

4. Find out if "rescue drugs" are allowed during this trial. Rescue drugs are drugs that are used to build up both red and white blood cells. W/R blood cells can fall precipitously during treatment because ribavirin and interferon cause them to drop. The experimental research drug may cause them to drop too (in addition to having other yet unknown side effects). If your red or white cells drop too low, you may be forced into an interferon and/or riba and/or PI dose reduction(s). If things got bad enough you may even be discontinued early altogether (possibly forcing a failed treatment and/or you being saddled with a PI resistant virus). Reducing the dosage levels of any or all of these drugs can make it much less likely for you to get cured, especially if the new drug isn't that effective and especially if the dose reduction occurs early in treatment (which is the most critical phase of treatment). Furthermore, if you end up in the control group (that does not receive the PI), this could really negatively affect your chances of being cured. If you treated with SOC outside of the trial you'd have access to rescue drugs and would be more likely to maintain full dosage throughout your treatment (thereby helping to ensure a successful treatment in the end). So a denial of rescue drugs could be a major downside depending on what group you end up in (and if the PI turns out to be relatively ineffective). This is a major wild card, do not underestimate it.

5. Find out what other medications you will be allowed to take in order to deal with the usual side effects (and maybe the not so usual). For instance can you take antidepressants? Can you take all the usual pain meds for fever, body aches etc? Steroidal lotions/creams and/or prednisone for skin itch/rashes? Is anything precluded, and if so, what and why? etc...

6. If you do not have good health insurance, will any ancillary care (or drugs) you may need to deal with your side effects be provided by the trial coordinators? For instance if you need to see a dermatologist (as I did as a consequence of a nasty rash caused by the research drug) will they set you up with a derm in a timely manner and pay for their services? etc...

7. Can you see and have copies of all of your labwork during the trial? Will your blinding even include ordinary labwork that does not pertain to viral load?  When will the blinding period end? This is critically important to know about, make sure you get the details in writing.

8. Since this trial is blinded, find out the specifics about when you would be considered a treatment failure and when you would be discontinued. They like to wiggle on this one, I know of several people that were kept on the drugs for weeks or even months when it was more than the clear the drugs were not working. That is they were persistently not UND and obviously experienced a viral rebound and yet were kept on the drugs for a prolonged period of time anyway - not good! Know the specifics about when they will throw in the towel and when you will be advised of it.

9. In the trial info they state that those within certain groups that experience an RVR (rapid virological response) will be discontinued after 24 weeks. How is RVR defined? Usually it means going UND by 4 weeks, just ensure that they're using that same standard.

Ok, that's about it for starters. If you get serious about this we can go into more details, but this should be enough to get started.
Helpful - 0
179856 tn?1333547362
I am a bear when I get sick...the thought of not being able to use the "helper drugs" scares me. How can they convince you to stick with the study if you feel like ****?


It is a very difficult decision to make.  Considering it appears you don't have very progressive liver damage I don't know if I'd take the chance and go with the regular standard care so I could get the rescue drugs if I needed them - and save the trial for a second attempt if I needed it.

It doesn't appear you are in a great rush - unless you choose to be.  You can talk it out with your doctor and with some of the folks on here and really think of what might be best for YOU.

Pretty much for all of us it's a great big giant crapshoot - which treatment, how long yada yada it seems we are always making decisions and having to WAIT on other things.  But let me tell you - once you clear the virus and achieve "SVR" and know that you are CURED...it makes it ALL worth it in the end.

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96938 tn?1189799858

Here are a few more places to visit to get an understanding of what's in the pipeline and other information to noodle upon:

http://www.hivandhepatitis.com/

http://www.janis7hepc.com/
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Avatar universal
http://clinicaltrials.gov/ct/show/NCT00517439?order=13

this is the study my doctor has encouraged me to participate in.

PS thank you for the website...I never new it existed


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Avatar universal
I wasn't trying to scare you away from all trials, just letting you know that they do not always offer the best chance of being cured, and there can be many pitfalls. Pitfalls that may escape you if you are not properly educated on what's going on before you enroll in one. It depends on a lot of things, so again I would suggest that you take the time to learn more about your disease and the treatments for it. In the meantime if there's a particular trial you're thinking about enrolling in, then get the details about it and run it by the folks here. We can probably give you at least some good advice about it and what to look out for in the sense of downsides.

Also, why set the stage for an impending hardship by starting your treatment just prior to tax season? Unless there's a really great trial you want to enroll in with a "now or never" deadline, you can start treatment whenever the time is right for YOU. Remember, YOU'RE in control of your healthcare and letting someone else set arbitrary deadlines for your treatment is not the way to go. Or maybe you've set some kind of arbitrary deadline for starting treatment and have a sense of inevitability or resignation about it for whatever reason? If so, no need to. Be calm, analyze your situation and take the time to learn enough about what treatment to take and when the best timing is to start it.
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96938 tn?1189799858
Go to clinicaltrials.gov and, in the search bar, enter the word 'hepatitis' and the nearest city.  You'll see trial-related information.

Before you say word one to you employer, stop and think about that that decision.  You don't know that it will affect work or the extent.  If there is anything that an employer should be able to fire a person for it inability to perform, not for having a disease.  Caution in telling your employer.  

We have a member here who has been through two tax seasons on treatment, maybe she can share her experience.
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Avatar universal
I had a biposy in May 07; 2/18 inflammation and 1/6 for fibrosis

I am scared sh*tless to get treated but I am also anxious to get it ovvvver with. I though the clincal trial was the best choice.....but now you all have me reconsidering.

Is Roche the only company who makes the drugs and runs the trial? I feel like I am way out in left field................

I am a bear when I get sick...the thought of not being able to use the "helper drugs" scares me. How can they convince you to stick with the study if you feel like ****?

Haven't told the employer yet that I will be starting treatment and that it will affect work. I work for a CPA firm so the upcoming months are going to be CRAZy! I thought of getting a lawyer to ensure i have "all my t's crossed" in case i get fired due to inability to perform
Helpful - 0
250084 tn?1303307435

This site is the best, great bunch here, willing to help and listen.
  So many decisions you make in this are tough, and there will be many besides just which tx to do. Lifestyle, work, who to tell, etc. Do you have to tell your employer? Many of us just give another disease, or none as in the stigma your already feeling and sadly, it's out there. I cut myself at work last week, everyone ran over to help, I grabbed a towel and hustled off to the bathroom saying 'I’m okay'. They would not have done that had they known. It can hurt. You've done NOTHING wrong here to feel ‘dirty, guilty, ashamed', please try to rid yourself of that. Just think carefully on who you decide to tell.
  I am in a trial but it is not as 'heavy' a trial as many here, (albumin, basically same interferon moleculed to Albumin, not such a 'new' type drug) but I also 'drew' the regular tx, Pegasys/Riba so didn't get the study drug anyway, yet with lousy insurance, a Godsend as cost is covered. I can't get 'rescue drugs' tho so that is the downside of it.
  Others, as above, know much about trials and mremeet is a pro in a lot of that. I agree with the others, get a biopsy, stage, see where you are in this. I am not sure if a trial before the norm is good or not (mremeet??).Age helps as in how far along liver damage is, also often in ‘acute’ , not chronic if young and healthier to handle, etc. If you have time to wait, several 'easier, better' treatments around the corner.
  Good Luck in all ahead,                                           LL
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Avatar universal
This is just my story......was so excited to be accepted into a trial. Did a 6 hour physical, drug screen, gallons of labs, EKGs, breathing tests, etc. and the day  before the first shot they call me up and tell me my neutrophils were just points under so I flunked the study requirements.

I am on week 7 and paying almost $500 a month for my meds but guess what. I have very few side effects, my doctor can give me any med he desires, but unfortunately I am about two months behind in my treatment timing.

I thank God every morning on my knees that I am able to go to work and function. How do I know what the clinical meds would have done.

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Avatar universal
Platelets don't carry oxygen - red blood cells do.

You also say "the younger you are, the better chance you won't become anemic".
While I know that everything seems easier when we're young I haven't heard that the young are less likely to become anemic while on treatment. Perhaps you have a source for that. If so, could you post it.

Mike
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233616 tn?1312787196
the younger you are, the better chance you won't become anemic, the diet being healthy.
yhe other unknowable however is that while platelets that carry ozygen can go too low, iron can also get too high, particularly in those with latter stage disease. Discuss with the doc and eat very healthy, no caffience to rob you of minerals, electolytes etc.
the trials are tempting now becuasse the Telprivir has a better outcome in early trials, but that is only better for the half NOT getting the placebo.
In the trial you will get INF/Riba either way, but the question becomes can your bloodstream stay strong enough without the Procrit.
If you are exausted. short of breathe and basically like a fish on the embankment, that's not a good thing.
why the trials insist on denying helper drugs, don't know, other than "pure outcomes" for their new babies, but it's cruel to those who need other helps so it's a tough call.

In my case, I cannot keep food or water down the day after shot...so that means I either take a helper for nausea, or I can keep the Riba down either.

IKnowing what I know now, I'd take standard over trial tx for the first time round, just so as to not go through any more hell with untreated side effects than nessessary, but that's just me.
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179856 tn?1333547362
Welcome to our little nuthouse!  We all might be a little whacky but everyone here will do their utmost to help you work through this all.

I am (scratch that) WAS a geno 1A and also a 1B.  Got rid of them BOTH!  :)  There is hope on the horizon so have faith.

Anyway - have you had a liver biopsy yet?  It's important to find out what grade and stage your liver damage is at, it is THE factor pretty much in deciding if you need to do treatment right now or it you have time to wait.  For example if you do have time to wait, if you have only a small degree of damage - you could skip the "trial" and wait and see if the drug (Telepravir most likely) is approved by the FDA.  That might be important as some of our side effects CAN be treated by other drugs but they generally will NOT let you take them (Procrit, Neupogen) while on a study.  to me that would have made all the difference of whether or not I was able to complete the course of treatment as I totally got slammed with the anemia and would not have been able to continue onwards without the Procrit.

Just a thought. I didn't have much choice. I found out I has this in July and started treatment in the beginning of September (as quickly as I could) - I had it for probably 20 years and never knew it but already my liver had decompensated to a stage "3" which didn't leave me much maneuvering time until cirrhosis.  But, you could be a stage 0 or 1 and that would mean you really have some time to see what plays out with the trial drugs if you want to.  Personally, I had decided to go for it no matter what stage I was at just because I wanted it OUT of my body. But...I'm kind of whacky in the first place.

Good luck, there are great resources here on this forum and even better people who will do anything they can to make it an easier time for you.  We've ALL been there and so we completely UNDERSTAND whatever it is you need to know...chances are someone here has an answer.

So ask away!
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Avatar universal
Welcome to this great forum. Most likely you will not die from hepatitis C. You will live a long life and die from something else (as we all will). It is a very slowly progressing illness (unless you drink alcohol). This is the time to do research. If you can get in a study trial that would be great - you will be part of the research. There are many on this forum who are or have been in clinical trials.

I'm 65 and just completed tx 6 weeks ago. Feeling better every day now. I'm also geno 1a and I did 51 weeks of INF/RIBA. Take good care and best wishes to you.
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Avatar universal
Was genotype 1a, the toughest to treat. Hepatitis C can be beaten, believe it!
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Avatar universal
First..thank you for your kind words.

Are you...or were you! :).... type 1?

From the La-Roche website:
"HCV polymerase inhibitor pro-drug in combination with PEGASYS plus Copegus, compared with the currently approved combination of PEGASYS plus Copegus, in treatment-naïve patients"
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Avatar universal
I have, just wrapped up my treatment about 5 months ago. I'm cured now so I'm very grateful to have gotten into the trial. But it ain't all roses, there can definitely be significant downsides to enrolling in a drug trial. There's a lot to it, all the ins and outs. If I were you I'd do a search for VX-950 and Telaprevir, which many people here are currently taking in a trial (and that's what I took). Read all about the possible side effects and the mechanics of the trial and what can go wrong for you as a patient. Basically you should embark on an educational process before you treat, not just learning about trials. Learn as much as you can about your disease and learn as much as you can about existing treatments and emerging treatments. It'll take some time, but that knowledge will help you to eventually find your way to a cure. And by the way, I received a blood transfusion in the mid-80's too that I needed in order to save my life and that's how I got it too. It's a paradox that we have to live with, on the one hand the blood saved our lives, without it we would have died. On the other hand we were given a little present that remains with us today. A deal with the devil if there ever was one. But this is one contract with the devil that can be torn up and disposed of. Wishing you the best of luck getting your contract annulled, I can promise you it's a great feeling.
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