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1084115 tn?1385228589

trial people question

hello there,

i would like to know how often you have/had to visit your hospita/uni during a trial?

next year maybe i can go in the tmc435 trial,the hospital/uni is 120 km away from my home.with my car it takes me around 90-100 minutes to go there.

thanks for answer
11 Responses
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971268 tn?1253200799
P.S.  Of course the visit schedule for this trial could be different, though I imagine it is likely to be roughly the same. In any case, before you agree to anything they will give you a big consent form that clearly spells out all the required visits, so you'll be able to see it all ahead of time.

We have the consent form for the treatment-naive trial, so if you want to know anything else I may be able to help.
Helpful - 0
971268 tn?1253200799
My husband is on the treatment-naive version of this same trial.  His visits are as follows:

Day One (a very long visit)
Day Three
Day Seven
Once a week for the next month.
Once every two weeks for the next month.
Once a month after that.

So, I would think if you could stay there for the first week, then it would only be another three weeks of weekly visits, two more the next month, and then one per month.

As I think I've said to you before, we're happy so far with this trial, but of course the outcome isn't determined yet.  Good luck whatever you decide!
Helpful - 0
Avatar universal
My visits were 2 X a month for the first 3 months, (6 visits.)After that it was one visit a month(4 visits) until i finished at week 48.Comes out to about appox 12 visits for 48 week.

"Adam and Eve ate the first vitamins, including the package.'  ~E.R. Squibb

Helpful - 0
1084115 tn?1385228589
yes ,about the link you postet i found the uni freiburg to wich o wrote my mails.

but in my emails i never asked for this tmc-435 trial.

i just asked for upcoming trials.for nonresponders.and he also not told me what kind of trial they will start in april.but i think he means this tmc trial.
Helpful - 0
Avatar universal
Rexx, is this your potential trial?

http://www.clinicaltrials.gov/ct2/show/NCT00980330?term=tmc435&rank=2
Helpful - 0
1084115 tn?1385228589
thanks alot  for all answers.

my point is that all poeple around me telling me im crazy go for a trial outside my country.
but i have no time for waiting till trials in switzerland are available for me again.
and this trial centre is just 50 km from the the swiss/german border.

what do you poeple think,should i go for that trial if i can?

my problem is that i still dont know for sure i can go in this trial.
i sent email before 2 weeks and asked for upcoming trials and told them my hep-c story.but my main question was if i can go for a trial outside my country
.
he replied within 2 days and said they will start a trial in april-may 2010.he asked also about my viral load at week 12 in my last therapy,cause i just told him my vl at week 4,24 and 48.
a replied the next day and also told him if they need some more data i can send my documents from my doc here.

till today i didnt became answer again and i dont know if i should wait or just send another mail and ask him if i can go in the trial for sure.
i dont wont to look like impatient and i know they are very busy sometimes.

iam f3 now and i just want to do something as quick as i can

my prof. in switzerland told me that he dont know when they start the next trial,because last year he asked me for a trial with boceprevir but at that point i started already with the standart treatment,i im very angry about me and this lost chance.
Helpful - 0
9648 tn?1290091207
I have a 2-1/2 hour drive (one way) to get to the trial center. I had the same visits as newleaf, but also some extras when my hemoglobin went down and they put me on a rescue drug and wanted more frequent blood tests. Unfortunately they would not accept a local lab and insisted on drawing the blood themselves and send to their own lab. I just looked at my calendar and (if it's correct) I had six extra visits in the 48 weeks. I'm now in the follow-up phase.
Helpful - 0
Avatar universal
My trial was a Phase IIb - Andiamo's point is well taken, as different trials will have different monitoring requirements - just the same you'll get an idea of what you might be in for.

Your distance is about the same as what I had for travel to my trial centre also.  Similar to Andiamo and copyman, I was there weekly for the first 4 weeks, then again at Week 6 and Week 8, then stretched out to Week 12 and then every 6 weeks after that.

Because my red and white blood counts were always right on the border though, my trial center had me doing CBC's on a weekly basis after Week 12 and pretty much for the duration.  They let me do those at a lab locally and had the lab fax them the results.  That's something you might want to keep in mind if you go on a trial and that kind of situation comes up.  I had to be present for PCR's - the viral load tests - but the weekly CBC's and the occasional additional test for CD4 counts I got done locally.
Helpful - 0
717272 tn?1277590780
My trial was sponsored by Schering Plough.  My visits were scheduled (per protocol) for day 1, weeks 2, 4, 6, 8, 10, 12, 16, 24 and 28.  If I had continued (due to being randomized into a longer arm) I would have gone also week 34, 40 and 48.  As it turned out, I was extra responsive to the TX and after the first 2 or 3 mos. I was in every single week being monitored for safety issues, like getting bloodwork for monitoring the effects of using the rescue drugs and infections caused by low neutrophils (19 visits instead of 9 for me).  Some people will be able to follow the intended schedule just fine, some, like me, won't.  

Then there are followup visits post TX at 4 wks post, 12, 24, 30, 36, 42.  You have a little more leeway with the scheduling of the followups, but need to try to hit their dates for the TX visits, since that data may determine when TX ends in trials with a response-guided TX possibility.

The travel becomes automatic. You'll gather up all your meds and cold packs (for the IFN and trial drug) and just go.  There may be some mileage money built in to the trial; be sure and check on that.
Helpful - 0
Avatar universal
my trial visits were similar to Andiamo1. You have many visits in the beginning for saftey reasons then they get less if everything is good with bloodwork, exams, etc
Good luck in the trial
Helpful - 0
220090 tn?1379167187
It varies considerably by trial.  The trial I was in had visits weekly for the first month, twice monthly for the next 5 months and monthly to 48 weeks.  We also had to keep a diary of all meds and bring that to each visit.

That was a phase 2 trial with more unknowns than later stage phase 3 trials, so my experience might not apply to your situation.
Helpful - 0
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