Unofficial update on follow up for Quantum trial

[joy5116]

Just came from the Quantum study site where they have word that a follow up (roll-over/rescue) trial is in the works specifically for those that were halted in the Quantum trial scheduled for the 2nd quarter.  This will not be the original 2nd cohort of the Quantum but is called Refractor.  
Also I thought I heard that the whole study was halted, don't know how accurate that is.
I didn't get to meet with the PI because he is out of the country but will next week.  The Quantum study will be unblinded and I will know my lab values and also if I were receiving placebo or drug.  So as usual hope for the best. This is quite the ride.
Joy

[joy5116]

Thanks, resistance is my primary concern.  I'm trying to decide this morning if I should get the AST/ALT (24 hr return) and the HCV, RNA, TMA tests (which takes 7-10 days to get back) on my own or just do the AST/ALT since the LFT's will be unblinded soon and I'm fairly certain they do the qualitative and quantitative.

[dointime]

Many thanks for coming on here and bringing all this very interesting information.  I hope you will continue and let us know more about the Refractor trial.

When you get your labs, and if you were actually on a study drug, it might be useful to ask for your resistance data.  This could be helpful for your future tx,

Best wishes,
dointime      

[joy5116]

Yes, I read that. What the PC told me today was different. She said Pharmasset would be offering a trial just for the group that was cancelled, called Refractor.  That's all I know. I can't find anything on it.

[HectorSF]

"December 16, 2011
Pharmasset Announces Intent to Amend QUANTUM Trial

PRINCETON, N.J., Dec. 16, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today that the company will amend the design of the QUANTUM Phase 2b trial of the guanine nucleotide analog PSI-938 and discontinue all treatment arms with a regimen containing PSI-938. There are 235 individuals with hepatitis C virus (HCV) in the study who are receiving treatment with PSI-938 alone or in combination with PSI-7977 or PSI-7977 and ribavirin.  During routine safety monitoring, the company detected laboratory abnormalities associated with liver function in subjects receiving PSI-938 300 mg once daily.  These laboratory abnormalities have not been observed in patients receiving PSI-7977 and ribavirin in the QUANTUM study or in other trials evaluating PSI-7977.  Both the 12 and 24-week PSI-7977 and ribavirin arms will continue unchanged, data from which will support  NEUTRINO, an interferon free, 12-week Phase 3 study of PSI-7977 and ribavirin in patients with HCV genotype 1 (GT-1). "

hector

[fretboard]

Ok, looked at your profile and figured it out.  stay well.  

[UKgirl55]

That's wonderful Joy! I just had a gut feeling they were going to come up with something else. I sure hope you know something real soon.

[fretboard]

Is there a clinical trial number with that?  Is this one of the Pharmasett trials?  Were you in a clinical trial that was halted?  Sorry I've just arrived on the scene. lol

[Bill200]

Good to hear they're following up and not leaving you guys out in the cold.