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184420 tn?1326739808

Schering-Plough NCT00797745

anyone know anything about this trial or drug?

SCH 900518 is a potent oral inhibitor of HCV NS3 protease which disrupts hepatitis C virus (HCV) polyprotein processing. SCH 900518, when added to the current standard of care (SOC), peginterferon-alfa plus ribavirin, would likely increase the proportion of patients achieving undetectable HCV-RNA levels and sustained virologic response (SVR). In this study, SCH 900518 would be used in combination with low doses of ritonavir to enhance the levels of SCH 900518 within the body and reduce the number of daily SCH 900518 tablets required. The purpose of this study is to identify the optimal dose and schedule (once or twice a day) of SCH 900518 plus ritonavir in previously untreated patients with genotype 1 chronic hepatitis C when given in combination with SOC. The study compares SOC to 6 experimental arms. In the experimental arms, SOC plus SCH 900518 doses of 200, 400 and 600 mg once daily or 100 mg twice daily with ritonavir 100 mg once or twice daily will be explored. The benefits of a 4 week lead-in with PegIntron and ribavirin prior to the addition of SCH 900518 will also be explored.

8 Responses
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881890 tn?1286553760
Sounds like you're ready for a shot of procrit!  (pending hgb ct, of course)    
Helpful - 0
751342 tn?1534360021
OK, I'm back from the beach. That is the study I'm in. I'm in the arm that gets just Peg and Riba for 12 weeks. I'm waiting on my result to see if I cross over or not. I'll be calling them tomorrow because I've taken a real turn for the worse with the sides. Almost passed out doing yard work, and can hardly get up the steps. And I think I'm depressed as well. Ask away if you have any questions, I've got my paperwork handy by the sick bed!
Helpful - 0
408795 tn?1324935675
Ok it's totally up to you when and how you tx but it's more likely that they would give you more of the PI than you need.


fret


Helpful - 0
863555 tn?1239133228
i'm in the arm 3 week 3 of this trial. Went from over 6mil vl pre tx to 34 in the first week!!!
bill
Helpful - 0
184420 tn?1326739808
thanks everyone pls keep this thread alive, ya i am thinking of participating, but its only phase 2, i might wait for the phase 3... im afraid of under dosing with the PI and maybe the phase 3 trial will resolve that question... as willy said i do not want to worry about potential resistance issues
Helpful - 0
751342 tn?1534360021
That sounds like the trial I'm in. I'm at the beach until late Sunday, so I can't confirm by reading my documentation. I don't trust my brain right now to say it is without double (or triple) checking. I've had a rough couple weeks and haven't been very active on the forum. I'm waiting on the result of my 12 week to see what the next step is. Very likely cross-over arm to the study drug, along with Ritonavir (that one I'm sure of). I'll watch this thread and post back with more info when I get back home.
Helpful - 0
Avatar universal
http://clinicaltrials.gov/ct2/show/NCT00797745?term=SCH+900518&rank=1
looks like a good trial.

I would expect it to be better than boceprevir or they wouldn't be advancing it.  Looks very promising but I don't think they got off the charts response per last EASL.  A few months ago it was 15X stronger than any PI.  Now it seems to be 10X stronger than boceprevir.  That is still a good thing.  To be fair there are many new compounds continually raising the bar.  Whatever is "top gun" this week may become second fiddle by fall AASLD.  Ten times more potent than boceprevir would be formidible.  It will remain to be seen how the tolerability/ toxicology aspects are.  It could be both more potent and more toxic.  That's what trials are for.....finding out.   ; )

Looks good and promising to me.  I like the structure of their arms far more than w/Vertex.  Standard for vertex is 1 control, 2 or 3  investigational arms. (chances of getting SOC is 1 in 3 or 4)

This trial has one control and 6 investigational arms; 1 chance in 7 of getting placebo (SOC).

Keep i mind that these also are dosing strength arms and therfore one *could* get a less than optimal dose of the new PI.  IF you treat with PI's you want to CURE or there could be potential resistance issues.

best,
Willy
Helpful - 0
87972 tn?1322661239
There's someone in here that is currently in that trial, although I don’t remember his name. It looks very promising, and they’re also combining it with an HIV protease inhibitor ‘ritonavir’. I think this is the drug Schering-Plough touts as “10 times more powerful than Boceprevir” in their press release. The trial info is available in clinicaltrialsdotcom, I believe. Are you considering participating?

Bill
Helpful - 0
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