I am not 100% sure about the control arm. I did participate in two phase 3 trials for peg/riba and interferon/riba before that. Neither trial was a blind trial. I think the purpose of phase 3 trials is to come up with hard numbers for cure rates. Since the efficacy has been established in the phase 2 trial, there is no need for a blind.
This is supposition on my part, so don't accept this as fact.
Hey guy, How confident are you about phase 3 not having a control arm? That would be good news. Haven't you been in a phase 3 in the past? thanks, jerry
I think the phase 3 trial will be 12 weeks of triple therapy followed by another 12 weeks of just ifn/riba. Phase 3 trials have no placebo and are not blind.
The best way to get into a trial is to become a patient of a prominent hepatologist at one of the major medical centers. Let the doctor know you are interested in a trial. You need to do this quickly, since the trials fill up pretty quickly.
Phase 2 trials are blinded and have placebos. I am in one now, but I am far enough along - 27 weeks - to know that I have the real drugs. Trials can be difficult: they require many doctor visits, keeping a diary ( a minor pain) but the big problem is they often don't allow rescue drugs.
Hello, I'm newly diagnosed and being nosey.
How do you get into a trial? Don't you have a possibility of receiving a placebo - or is that just a blind trial?
Anyone have extra info on trials, how they work etc that's participated?
How long do u think will be the duration of the therapy in Vertex Phase 3 trial ?
What are the SX in the last trial and how severe are they ?
So far, there are not test arms without Ifn and the one without Riba is not doing well. Someday, there will be a cocktail consisting of a few of the new drugs and probably no Ifn and Riba. My Doc thinks that is 5 - 10 years away before FDA approval is given.
Vertex is planning to start a phase 3 trial early next year. Unless the FDA bypasses the normal procedure, I think another 18 months beyond the start of the phase 3 trial before FDA approval.
Why don't you try and get into the next trial?