trial screening

[roscoe1]

Hey all. I go for my first appointment since getting the invite for R7128 trial. What should I expect on this visit? I am excited and fearful all at one time. I talked to the trial person and she said there were no notes for me to fast and did'nt know if I would do blood work or not. I read online what the exclusions and inclusions are, as far as that I'm in there. Any thing else I need to be prepared for? thanks to all R1

[roscoe1]

Just got back from my screening. I did the ekg, blood and physical, signed a consent. I was reading about your trial experience and the one I am going to do? Is the only difference the amount of time? He said after 24 weeks if you don't clear you do not get the study drug. I guess at that point I would drop out. I am suppose to start in late June. Still gotta get biopsy and wait for blood work to come back. And did you take any supplements while on tx? thanks so much for your input

[epiphiny]

PS:  I mean the trial that I was on was the first that tested the safety, tolerability and pharmacokinetics of the trial drug, hence it being phase 1.  Hope I didn't alarm you!

Also here is a link to the results from the study that DS and I were on that were presented at the San Fransisco Liver Conference last year:

http://www.pharmasset.com/pipeline/R7128-publications.asp

Also tells you a little more about the drug if you are interested.

All the best!!

[epiphiny]

Hi, I was also in the Phase 1 trial of R7128.  In fact, I was the first G3a non-responder to start the trial worldwide, by virtue of the sun rising here in NZ first!  

Anyway, on my screening day, which was my also my first appointment, they took bloods for a CBC analysis, LFTs and for a viral load and genotype confirmation.  I also did a urinalysis sample as they were testing for creatanine (monitors renal function), amongst other things, as that was one of the big inclusion/exclusion factors for my trial.  

As the trial was the first to be done on humans it may have established that R7128 is safe for the kidneys at the trialled doses.  Incidentally I was on the highest dose in my arm of the trial which was 1500mgs per day.  I had NO adverse reactions.

I also had an ECG, was weighed, blood pressure taken etc.  I also had to fill in an HAD test which they returned to on a regular basis to monitor the effects the SOC drugs were having on my mental health. They then made an appointment for me to have a biopsy the next day, as my last biopsy was over 2 years old.

After all the results were back in (approx 3 days) I started the trial shortly thereafter.  Screened on a Monday, biopsy Tuesday, started trial on the Saturday. I don't know if this is the speed that other trials work at but apparently the trial had to be approved by the NZ ethics board before it could begin and they dragged the chain a bit.  When the trial was green-lit it was all action!

I had to spend the first weekend in the research hospital where they monitored everything they possibly could!  As the trial was testing the pharmokinetics, safety, and tolerability of R7128 as well as it's affect on viral load this may have been more stringent, I don't what they are doing in your trials.

Btw, there has been another successful trial here in NZ and Australia using R7128 in addition to a protease Inhibitor with NO Interferon and Ribavirin.  

Anyway, like DragonSlayer, I think this drug has great promise and I know it has been fast tracked by the FDA as it has the potential to fill a void in current treatment outcomes.

As I was already treatment experienced I could tell what effects were from the trial drug and what was from SOC and I can honestly say there were no adverse reactions for me.  I did notice a few small changes that I attributed to the study drug but they were in no way unpleasant of painful.

I also got to RVR at 4 weeks which was amazing given that I had showed NO response to either interferon or riba in my previous treatment.

Anyway, all the best, hope you make it through the screening and get on the trial.  Please let us know how you get on!

Epi :)

[DragonSlayer45]

Unless you have already done all this you will probably get a ton of paperwork (consent forms etc.) and they will go over everything concerning the trial. They should then set up a schedule for you.

I totally understand everything you are going through. It is normal to be excited and scared at all the same time. You are excited about participating in a trial that may clear your virus and scared because you are about to embark into unknown territory. I had a lot of anxiety too.

I just want to wish you good luck in your appointment. I think you are about to participate in a great trial but I am biased, since I participated in Phase I and cleared at week 4.

Let us know how you made out!