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Hep C Discussion Forum -> Clinical Trial Participants -> Real or placebo?
Post Info TOPIC: Real or placebo?
Groupergetter


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RE: Real or placebo?
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Hope this works out for you Marcy.  Keep us posted, lot's of folks wanting to see you get through this. aww



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1b  Int/Riba relapse @ 48 weeks.  Stop tx Peg Int/Riba 12 weeks ill. Relapse S/O 6/23/14 :(   Started Harvoni 11/12/14  EOT 4/28/15.  EOT+4 UND :)  SVR! 8/4/15  :)     Thankful for every morning.
Milliganus


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Went for the initial screening for the Merck MK-5172/MK-8742 trial.  Trial coordinator makes it sound like I'll be in for sure provided my labs all look good.  I think they do, unless there's something I don't know.  This is a one pill day for 12 weeks trial, or placebo for 12 weeks then treatment.

I'm trying not to project into the future.....I'll think more about it if I actually get in.  Should know in a week or so. 



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND
suziq


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Hi,

Guess I was just lucky.  My Merck trial was not a blind study.  Think I'm the only one on this forum that has done the Merck trial.  You can see my progress on my signature line.  I did my trial in Arlington Texas.  Ask any questions you want and I will try to answer.  July 1st will be my last blood tests--end of treatment +24.  So far so good.

Congratulations on getting the trial.  Merck data so far is great.

SuziQ



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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR
JudeMzr


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Hi there, I was just accepted into that same trial and from what I read on the informed consent form is that you have a 25% chance of getting the placebo at the onset.  The doctor and staff won't even know in the beginning which group you are in .

Lets hope luck goes our way for both of us and we get into the active group right away ;)

Best of luck !

I started my own thread on my treatment road (mine starts next week)  and will surely follow yours. It will be an interesting year for us to be sure.

Basically I have just assumed in my mind that this whole thing will last until around the first of next year.  if I think of it that way,  anything else will be a pleasant surprise.  I am just happy to have gotten in.

Jude

Genotype 1A, VL 5Mil Treatment naive

-- Edited by JudeMzr on Saturday 14th of June 2014 02:20:47 PM



-- Edited by JudeMzr on Saturday 14th of June 2014 02:22:48 PM

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Hep C diagnosed 2007.   VL 7Mil . Genotype 1A.  Treatment naive.  Grade of  Inflammatory activity per 2014 biopsy:  A1   Stage/Degree of Fibrosis F0 
Huey


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Milliganus wrote:

Hi all,

Is there anyway to know if you are getting the drug or just a placebo.  I may get into a Merck trial with MK5172 & MK8742, no riba or INF.   Getting a placebo would take me an additional 16 weeks before the real thing.

 

Just curious if there's anything I can look for (if I get in of course).  Fingers crossed.smile

 with your geno type I don't know, but geno type 3 has a unique characteristic " hypoglycemia" ,  if your genotype has a unique characteristic like mine you would look for some kind of manifestation of this characteristic. If you don't have any change "sugar, blood preasure" something, you might not be getting the real drugs.



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  HCV Genotype 3a , now Psot-Tx was on S/riba. First VL was 5.8 mil on 7-5-13 then "und" at 3.8 weeks. 06/13/14 still und. off meds 3 days back on 7/29 Last pill 08/10/14 SVR+4

 
Scruffy


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I think if its a double blind study not even the Doctors know. All your blood work goes to the ppl running the study and if its your Doctor he won't tell you unless they pull you for health reasons or if you don't respond.  At least thats how it worked for me in 2003. Looks like you have good odds. Tig is right you would have to find a Doctor willing to test you for vl and you would have to know your base. Study Doctor might tell you your base vl.

Good luck on the draw.



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Geno 1a null responder 2004 inter/riba   finished incivek,peg/riba 48 weeks May 17th 2014. undetect weeks 4-12-32.  EOT+7 undetect. EOT+24 SVR!!!!! EOT+!YEAR SVR!!!!
Tig


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You'll have to do two things. First, you have to be willing to pay for your own blood testing. That includes finding a physician that understands you're on a trial and will order the necessary tests, like viral loads, and CBC's. You'll need to establish a baseline before treatment begins and then as treatment progresses, you'll have to have the tests performed, just like the trial center does to determine how the treatment is working. You would likely begin to experience some anemia. Not always but we tend to see some tell tale signs as tx progresses. Of course a viral load will be a big indicator. If you're on a placebo, you won't see any changes or side effects. Finding a doctor that will do it can sometimes be difficult if you haven't been a patient with them before the trial. There might be a rule I'm not aware of from the trial coordinator that prohibits your own testing routine. You'd be able to find out that kind of information fairly easily though. 

Tig



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Tig

67yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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OldenSlow


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Hi Marcy,

That looks like Merck's Phase 3 study. They will be putting 25% of participants on placebo in that one, so you have decent odds of getting the real deal. You can look through the side effects mentioned in their Phase 2 Report for some idea of reported sx. Headache and fatigue were the two most common complaints in the riba-free arm. 

If it were me, I'd assume placebo and figure it as a 28 week commitment, including the 4 week unblinding period. Chances are good it will break in your favor, but you never know. At least you'll know you get the real drugs eventually. Best of luck to you. wink

wayne



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66 y/o male - Geno 1b - F4 cirrhotic dx 2001 - 16 wk treatment w/ Sovaldi/Olysio/Riba - Und @ EOT+24 SVR

 
Milliganus


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Hi all,

Is there anyway to know if you are getting the drug or just a placebo.  I may get into a Merck trial with MK5172 & MK8742, no riba or INF.   Getting a placebo would take me an additional 16 weeks before the real thing.

 

Just curious if there's anything I can look for (if I get in of course).  Fingers crossed.smile



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND
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