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Avatar universal

anyone on sch 503034 clinical trial?

My husband had his 1st treatment 2-27. He is on a Schering-Plough clinical trial for sch 503034, a protease inhibitor. Has anyone been involved in a previous trial phase with this drug?
21 Responses
80575 tn?1207135964
I'm not on the 503040 Protease Inhibitor trial but was offered to be enrolled.  I declined because my damage is still minimal and I'm hoping for my next tx to be something less than six months.  Schering's trial is for 12 months.

Do you have a stats back yet on how your husband is doing?  That is has his viral load count gone down drastically?  Please keep us informed here with his progress.

Thanks and good luck.

Mike

Avatar universal
He is on arm 5 of the trial which starts with 4 wks of standard treatment (pegintron and rebetrol)and then begins the trial drug for the remaining 44 wks. Since he only had his 1st treatment 2/27, we haven't had a viral count yet, but will on the 3/13 and will post results. He had stage 0, grade 2 on his biopsy, but has known he had hcv for 10 yrs and decided to go for it anyway.
Avatar universal
I appreciate this information as well, as I had not heard of this drug before.  I'd certainly be interested in how well it's working, and hope for both your sakes it's working very well.  Thanks for your offer to keep us informed.  I'll be looking forward to it.
151263 tn?1243377877
This is really interesting, you're the first sch503034 person I've seen here (or anywhere). Is there any way you can explain how the trial is structured? Like all the groups and dosing schedules? Whether its blinded and/or has a placebo, when is unblinding etc etc??

Thanks, and best of luck to your hubby.
80575 tn?1207135964
I agree, you're the first Schering 503034 trial person to post here...please keep us informed about your husband's progress.

What's interesting about this drug is that like Vertex VX-950 it's too has been fast tracked by the FDA because of its anti-viral capabilities.  It's also interesting that 503034 is being developed by an extremely large European company (Schering Plough) that has conducted it's business very quietly and without all the fanfare like the much smaller company Vertex.

Schering has a lot to lose; their SOC Peg-Intron Interferon product is not used in the Vertex trials.

The Schering 503034 trials have been going on for over six months.  Are there other people in this forum going through the trial and what are your results to date?

Avatar universal
I'm signed up to start in phase 2 SCH 503034 in May, pending heart, eye and mental exams.  You're right when you say they are keeping very quiet about it. I don't find anything anywhere.  What I do have is the consent form which describes the 5 Arms as follows.

Arm 1: Pegintron 24 weeks, Rebetol 24 weeks

After 24 weeks the amt of virus in the blood will be measured to determine which treatment you will receive.

No hepC-continue as above for 24 more weeks
Dectectable hepC-SCH 503034, 800 mg orally w/SOC for 24 more weeks

Arm2: Pegintron 28 weeks, Rebetol 28 weeks, SCH 503034, 800 mg orally 28 weeks

Arm 3: Pegintron 28 weeks, Rebetol 28 weeks, SCH 503034, 800 mg orally 24 weeks
added after 4 weeks SOC

Arm 4: Pegintron 48 weeks, Rebetol 48 weeks, SCH 503034, 800 mg orally 48 weeks

Arm 5: Pegintron 48 weeks, Rebetol 48 weeks, SCH 503034, 800 mg orally 44 weeks
added after 4 weeks SOC
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