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Hep C Trials of VX-950
Are there any trials of VX-950 now enrolling volunteers either in the US or abroad?
I am also looking into this trial. I have never treated and have very little damage. Genotype 1- I had no idea when you do a trial you are not allowed any rescue drugs. I have an appt with my Gastro in 2 weeks and I want to discuss this with him and now I am having doubts. Is it safer to do Pegasus/Copegasus with all the help. I am aware of all the sides and can't imagine not being able to have help with them. Can anyone give me some advice.
Man , I'm sorry to here about the delay. I know it's driving you up the wall. Hang in there , it will be here before you know it.
On another note , I would love to go to the ACL Festival in September , but it looks like they only have 3 day passes for sale , I doubt I could hang that long. I saw that Cliff Antone died , Shame , the guy really did alot for the Austin music scene.
Take care ,
52tele
On another note , I would love to go to the ACL Festival in September , but it looks like they only have 3 day passes for sale , I doubt I could hang that long. I saw that Cliff Antone died , Shame , the guy really did alot for the Austin music scene.
Take care ,
52tele
Don't quite understand your point... In my post i has said i did not think vertex was one using a placebo. As for tx naive. Of course all new trials are. Are you saying someone with little or no damage that has time to wait jump right in the early trials, shouldn't they wait for vertex to prove them selfs more?
Vertex says....Trials for non-responders projected for second half of 2007... 'Projected is the key word there.' What happens when they add the ribavirin? Will they use rescue drugs?
you said... It does not appear that slow responders will be dropped, at least as defined here (in terms of RVR) from above referenced release:...... But could happen right? and when they add the ribavirin what happen if you have a quick drop in your hgb? They either lower the dose, boot you out, or use rescue drugs. Which most don't. And has vertex said they will?
Just think someone one with little or no damage should NOT jump right in the early trials and make their self tx naive. While this drug looks good now as you know lots can happen.
Vertex says....Trials for non-responders projected for second half of 2007... 'Projected is the key word there.' What happens when they add the ribavirin? Will they use rescue drugs?
you said... It does not appear that slow responders will be dropped, at least as defined here (in terms of RVR) from above referenced release:...... But could happen right? and when they add the ribavirin what happen if you have a quick drop in your hgb? They either lower the dose, boot you out, or use rescue drugs. Which most don't. And has vertex said they will?
Just think someone one with little or no damage should NOT jump right in the early trials and make their self tx naive. While this drug looks good now as you know lots can happen.
Just because your primary or treatment doc goes on vacation it shouldn't mean you can't get the bx results if they are ready. Chances are if the doc is on vacation so is his office. Before he leaves try to get the name of the pathologist who will read the biopsy. It does not make a patient any less anxious knowing the doc is recharging his batteries in the south of France. Tell him you want to know when the results are ready.
Recent Vertex press release with projected dates and more detailed information on upcoming trials:
http://www.vpharm.com/Pressreleases2006/pr052306.html
Recent thread with some discussion:
http://www.medhelp.org/forums/Hepatitis/messages/40952.html
Vertex Webcast: http://www.vpharm.com/
(takes 30-60 minutes to listen to)
-------------------------------------------
Regarding some concerns and points made, but please double-check with Vertex release and webcast above --
1)Initial trials for treatment naive.
2)Trials for non-responders projected for second half of 2007. (Phase IIb study)
3) No one will receive just a placebo. However, intially, one arm will substitute a placebo for Vertex, meaning treatment would be peg and ribavirin.
4)Depending on results of Phase II studies, the Vertex placebo arm could be dropped for Phase III projected for mid-2007.
5) There will be a Peg and Vertex arm only (no ribavirin) but for now that is only planned for the European study.
6) It does not appear that slow responders will be dropped, at least as defined here (in terms of RVR) from above referenced release:
..." As in the PROVE 1 study, patients in the 12 and 24-week treatment arms who achieve a rapid viral response (RVR) defined as undetectable (less than 10 IU/mL) viral levels by the end of week 4, and who maintain this status through to either week 10 or 20 respectively, will stop all treatment at the 12 or 24-week time point and will be followed post-treatment to evaluate whether they achieve SVR. Patients in these treatment arms who do not meet the RVR criterion will continue on peg-IFN and RBV for a total duration of 48 weeks. The 24-week treatment arm will evaluate whether 12 weeks of additional treatment with peg-IFN and RBV adds substantially to the SVR rate compared to 12 weeks of VX-950 in combination with peg-IFN and RBV."
###
http://www.vpharm.com/Pressreleases2006/pr052306.html
Recent thread with some discussion:
http://www.medhelp.org/forums/Hepatitis/messages/40952.html
Vertex Webcast: http://www.vpharm.com/
(takes 30-60 minutes to listen to)
-------------------------------------------
Regarding some concerns and points made, but please double-check with Vertex release and webcast above --
1)Initial trials for treatment naive.
2)Trials for non-responders projected for second half of 2007. (Phase IIb study)
3) No one will receive just a placebo. However, intially, one arm will substitute a placebo for Vertex, meaning treatment would be peg and ribavirin.
4)Depending on results of Phase II studies, the Vertex placebo arm could be dropped for Phase III projected for mid-2007.
5) There will be a Peg and Vertex arm only (no ribavirin) but for now that is only planned for the European study.
6) It does not appear that slow responders will be dropped, at least as defined here (in terms of RVR) from above referenced release:
..." As in the PROVE 1 study, patients in the 12 and 24-week treatment arms who achieve a rapid viral response (RVR) defined as undetectable (less than 10 IU/mL) viral levels by the end of week 4, and who maintain this status through to either week 10 or 20 respectively, will stop all treatment at the 12 or 24-week time point and will be followed post-treatment to evaluate whether they achieve SVR. Patients in these treatment arms who do not meet the RVR criterion will continue on peg-IFN and RBV for a total duration of 48 weeks. The 24-week treatment arm will evaluate whether 12 weeks of additional treatment with peg-IFN and RBV adds substantially to the SVR rate compared to 12 weeks of VX-950 in combination with peg-IFN and RBV."
###
Your welcome, I think there was a thread in archives on things to ask before enrolling in a trial.
here are some possible things to read:
http://www.wsaw.com/news/features/1/2744796.html
http://www.healthlit.org/scienceInside/eb_biomedresearch.htm
http://www.annescancer.ca/clinical_trials.html
here are some possible things to read:
http://www.wsaw.com/news/features/1/2744796.html
http://www.healthlit.org/scienceInside/eb_biomedresearch.htm
http://www.annescancer.ca/clinical_trials.html
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