anyone on sch 503034 clinical trial?

[scaredwife]

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?

[miked]

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

[scaredwife]

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.

[ChrisDDD]

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.

[mremeet]

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.

[miked]

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?

[Terrylee8]

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

[web52]

what phase is this trial? where are the sites (europe, states, etc)? do you know how many subjects they will enroll?

[Terrylee8]

I am in Sacramento.  There will be 10 in my group. I'm not sure about how many total.

[chcnme]

Indeed it's nice to see someone in this trial  (you're the first I've seen, too.)  Both of you are.   Wishing you the best.  I began hearing about SCH503034 last year.  My doc said it was looking good. He offered me HCV 796 (Wyeth) recently.  There are no sites listed on the sch503034 at clinical trials dot gov / just the trial info.  (of interest - I remember reading several articles last year about Schering Plough being under fire for 503034 because it was alleged they weren't a giving fair chance to black people to get in the trial.)  

Best of luck to you both!  

[miked]

I was given the protocol information and consent form back in June 2006.  Schering was looking for 1a and 1b non-responders of SOC.

If I decided to move forward tx would have stated immediately.  As stated previously I have minimal damage and opting for a shorter tx time so I declined.  However there are people out there who did start in June 2006 or earlier which would put them at the 10 month mark.  

Is anyone on this board in the SCH 503034 trial that started around 10 months ago?  If so and if permitted, would you share how you are doing?

[scaredwife]

The total number of participants in this Phase IIb is 400 and I believe its worldwide. Schering has been very low key and cautious about this drug even though it's on the FDA fast track like VX-950. Their Phase I results were not as impressive as VX-950; however, they started with non-responders and a very low dosage. This Phase includes treatment naive and a much larger dosage. I'll keep everyone posted.

[mremeet]

Thanks for update, much appreciated. Do you know if rescue drugs like Procrit and Neupogen are allowed during this trial?

[scaredwife]

They told us to make them aware of any adverse symptoms and they would provide medication, so I'm guessing that includes all rescue drugs (I hope!).

[mremeet]

Might want to look into the rescue drugs. That was a BIG caveat in the VX950 trial I'm in. VX950 was dosed along with ribavirin and IFN for the first 12 weeks of treatment. If your hemoglobin (HGB) dropped below 10 or so (making you anemic) they would reduce your dose of ribavirin. If your neutrophils (a white blood cell that fights infections) dropped below 750, then they would reduce your IFN dose. Both of these actions will lower your viral response to the drugs, possibly enough so compromise your chances of achieving SVR. This is especially true if you are in the placebo/control group (i.e. for those who aren't "getting the good stuff"). And these situations would otherwise be largely avoidable by the use of procrit and neupogen, which are specifically designed to boost HGB and neutrophils (and would normally be available if you were receiving SOC alone).

[Terrylee8]

The consent form allows rescue drugs albeit SC states that they won't provide them

[willows]

If my tiny little brain remembers right, Scherings drug is a polymerease inhibitor and is the drug talked the most about as being used in conjunction with VX950 as a combo tx in the future.  It would, of course, use IFN also, but at least no riba.  

You are all so right about the "quietness" of the trials schering is doing, there is no info anywhere about it.  Ah, well, some secrets are sooo good, they are worth keeping.  Good luck to all!!

Willow

[miked]

I've never heard anything about SCH503034 and VX-950 being combined in a trial.  From what I understand they are both protease inhibitors.

SCH503034 did not receive initial results as attractive as VX-950 but again, this one's been quiet and Schering is a huge company.

Again, anyone with trial information, please share with us.

[chcnme]

It's a protease inhibitor.   Here's a press release from Nov.

(excerpt)

Schering-Plough News Release  
  
Schering-Plough's Oral HCV Protease Inhibitor Demonstrates Potent Antiviral Activity as Monotherapy and in Combination With PEG-INTRON(R) in Phase I Studies

Results Reported at American Association for the Study of Liver Diseases (AASLD) Meeting
Large Phase II Combination Study Under Way
SAN FRANCISCO, Nov. 14 /PRNewswire-FirstCall/ -- Schering-Plough's investigational oral hepatitis C protease inhibitor (SCH 503034) capsules demonstrated potent antiviral activity and was well-tolerated, both as monotherapy and in combination with PEG-INTRON(R) (peginterferon alfa-2b), in Phase I clinical studies in patients chronically infected with hepatitis C virus (HCV) genotype 1 who were nonresponders to previous therapy, including peginterferon combination therapy. HCV genotype 1 is the most common form of the virus worldwide and is considered the most difficult to treat successfully. Currently, there are no products approved for treating HCV patients who failed previous therapies, representing an area of great unmet medical need. Chronic hepatitis C affects more than 10 million people in major world markets and is the leading cause of chronic liver disease.

The results of the studies were presented for the first time at the 56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).

"These early results are important because they show protease inhibitor SCH 503034 exhibits a potent and direct antiviral effect on HCV genotype 1," said Professor Stefan Zeuzem, M.D., Saarland University, Homburg, Germany, who presented the data. "This promising oral antiviral agent may point the way to future HCV treatment regimens that are more effective, less toxic and shorter in duration."

------------

Phase II Study Ongoing

Based on the results of the Phase I clinical program and extensive preclinical safety and pharmacology studies, Schering-Plough has initiated a large, randomized Phase II dose-finding study involving 300 patients worldwide. This study is designed to evaluate the safety and efficacy of SCH 503034 in combination with PEG-INTRON, with and without added ribavirin, for 24 or 48 weeks in patients with chronic HCV genotype 1 who were nonresponders to previous peginterferon and ribavirin combination therapy. The primary objective of this study is to determine the safe and effective dose range of SCH 503034 in combination with PEG-INTRON in this patient population. A secondary objective is to explore whether or not ribavirin provides an additional benefit when combined with SCH 503034 plus PEG-INTRON.


Press Release:
http://tinyurl.com/yv98wn

[Kit07]

There is a wee bit of info about SCH503034 in a table in this review article about new drugs in development.  This article is a Jan '07 newsletter from the Halt-C study which is a multi-university investigation into interferon as a maintenance drug for cirrhotics.  It's a pretty good little review article.  I see that the table shows Schering is/was looking for non-responders (?) and it only lists two arms of the study  hmmmm.

http://www.haltctrial.org/Jan2007newsletter.pdf

or via   www.haltctrial.org

This is a great thread!
Kit
(lurker)

[Kit07]

whoops edit:  the table shows Schering is/was looking for tx naive patients...

Kit

[scudvr3]

Hello,

I also am in the schering phase 3 trial. I start treatment on march 7. I had a viral load of 3.95M with 1a genome. I have have this for over 30 years and did not know it. I have stage 3 grade 4 liver biopsy. I am currently on control arm 2.

I will go back on March  21 for the two blood test. Will not know the results for another week after that. But will post as a find out. I am very hopeful for this.

The quiet nature of schering on the drug may be because schering has deeper pockets than vertex. Vertex needs to hype as much as they can.

Currently since I started taking this I feel better than I have in years. It's early yet and the Peg/Riba has not built up in my system so this could change. The one physical observation that I have noticed is that my urine is no longer dark brown. It has cleared up. Very dark urine is a  symptom of HCV. I have not seen clear urine in 10 years. No matter how much water I drink. So something is happening. Hopefully positive.