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Thalassemia Patients and Friends and thalpal Ā© A. Battaglia 2019





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Author Topic: Phase 3 Luspatercept Trial  (Read 38330 times)
Andy Battaglia
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« Reply #15 on: January 05, 2016, 06:22:32 PM »

There's still no update about when or where the trials will start to recruit patients.

https://clinicaltrials.gov/ct2/show/NCT02604433?term=luspatercept&rank=1
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Andy

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« Reply #16 on: January 14, 2016, 04:06:20 AM »

Thanx for the link , Andy .... here is something what the site say regarding recruitment :
Quote
This study is not yet open for participant recruitment.
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Sometimes , God breaks our spirit to save our soul.
Sometimes , He breaks our heart to make us whole.
Sometimes , He sends us pain so we can be stronger.
Sometimes , He sends us failure so we can be humble.
Sometimes , He sends us illness so we can take better care of our selves.
Sometimes , He takes everything away from us so we can learn the value of everything we have.

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Sharmin
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« Reply #17 on: January 14, 2016, 08:31:46 AM »

My understanding is that trials may start this spring.  The trials will be double blind.  2/3 of the patients will reveive Luspatercept and 1/3 a placebo.  Patients who are selected will be ones who live in close proximity to the clinic from which the trials are being run because they will be required to attend the centre every 3 weeks for repeat doses and assessment. 
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Sharmin
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« Reply #18 on: January 14, 2016, 09:05:28 AM »

Sharmin,
it mean's no chance for me to participate in this do or die attempt :D ...
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Sometimes , God breaks our spirit to save our soul.
Sometimes , He breaks our heart to make us whole.
Sometimes , He sends us pain so we can be stronger.
Sometimes , He sends us failure so we can be humble.
Sometimes , He sends us illness so we can take better care of our selves.
Sometimes , He takes everything away from us so we can learn the value of everything we have.

===========
Umair
Andy Battaglia
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« Reply #19 on: January 14, 2016, 11:10:13 AM »

We have to wait and see where trials are run, but it is expected that this drug will not take a long time to reach the market once trials are concluded.
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Andy

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« Reply #20 on: January 20, 2016, 08:30:41 AM »

Do you think the trial will last 3 years or will they conclude after the 48 weeks period? I thought this trial was only going to be for a year. It says trial completion 2019
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Andy Battaglia
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« Reply #21 on: January 20, 2016, 11:02:31 PM »

It probably means trials in more than one location starting at different times. There would be no need for an individual trial longer than one year.
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Andy

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« Reply #22 on: January 29, 2016, 09:56:41 AM »

so that means we have to wait til 2019 for approval? Undecided

btw.. whats with the delay?? they said trial would start "end year 2015"
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Andy Battaglia
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« Reply #23 on: January 30, 2016, 12:07:30 PM »

I have emailed the Associate Director of the Clinical Trial for Luspatercept. I will report if I receive any reply.
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Andy

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Parin
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« Reply #24 on: February 01, 2016, 12:03:15 AM »

Thank you Andy for follow up....

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Sharmin
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« Reply #25 on: February 01, 2016, 10:30:05 AM »

Thank you for looking into that Andy, this study is of great interest to everyone.  If it works as well as the potential it has shown thus far - it will revolutionize the treatment of thalassemia.  Reducing transfusions, depleting iron stores - it is the answer to so many problems.

Sharmin
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Sharmin
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« Reply #26 on: February 03, 2016, 06:06:39 AM »

thanks Andy for following up! this one has great potential for all of thals...
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CrazyPharm
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« Reply #27 on: March 02, 2016, 10:49:10 AM »

Trial locations have been updated massive trial! Looks like it is ready to start soon! Good news
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Sharmin
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« Reply #28 on: March 02, 2016, 07:51:37 PM »

That's wonderful CrazyPharm!  I'm happy for all thals.  It's amazing that this treatment not only has the potential to reduce transfusions - utilizing iron stores but it also reverses so many of the negative effects of thalassemia.   Let's hope that by this time next year we know that the drug works like a charm and that more thals are preparing to transition to this treatment. 

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« Reply #29 on: April 02, 2016, 10:56:10 AM »

Update:

Trial has started in Childrens hospital Los Angeles. Excellent news I hope the trial goes underway in FULL very soon. We need this drug ASAP
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