Anyone have Any thoughts about bleeding with Gsk drug? On our sons screening visits for the us phase 2 trial, fibrinogen too low and inr too high to get randomized-

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I mean Gsk drug...

Are you referring to the GSK exon skipping trial? Has he been in the trial? One of the known side effects of the drug is reduced coagulation. It's something they monitor throughout the trial.

Hi Laurie,
Thanks for your response!
I mean the US exon skipping trial that is recruiting now. our son is , for now, disqualified from starting the trial and I'm wondering if he'd ever be able to take the drug when it's commercially available. I"m wondering which
Coag tests are affected and if there is any clinically significant bleeding assoc with the Exon skipping drug.
Erin

I believe bleeding is not a concern at all in exon skipping trials. All side effects are getting monitored closely throughout the trial.

Anup

I would think if he was screened out of the GSK trial, he would not be a good candidate for the drug once it's commercially available unless his coagulation numbers were watched very carefully. My son is in the GSK trial in France (we're in the UK but moved here last year from the US). They take blood coagulation very seriously.

You can correct those right? Can you treat and get those levels in range? If you can, then I see no problem to use the GSK drug if approved. The AVI drug doesn't have those side effects, hence he can use it if ever approved. These drugs are years away from approval so I would consult doctors to get those levels in range if possible.

Rouxsmom - What was your son's inr level? We had the same issue with the inr level, but not fibrinogen. Which hospital were you doing the screening?

We are going to the Portland Demand V trial site.  We had hope when our local children's hospital hematologist repeated the labs and the PT was normal, fibrinogen above the cutoff.  Then we went back to portland, got blood redrawn, and at GSK's labs the pt was just barely qualifying and fibrinogen was still low.  Now waiting for hemalogist and neurologist to connect, but we're pretty discouraged.  I'm hoping this is an error with GSK's lab, but would be surprised if they admit that.  Dang.

Hi Rouxsmom. I just sent you a private message regarding the Gsk trial.
I just resent it. It includes our phone numbers. We are dealing with similar issues for our son, Daniel. Let me know if it did not go through.

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