trial

well another trial chance bites the dust...screened for the danoprevir trial and my VL came back at 2 k ...this is crazy ...beginning to think that a trial will never happen for me...this was the 3rd trial ive screened for...1st time VL was 7k, 2nd time  2 k, this time 2 k...have had this monster 25 yrs...guess ill wait for Tel or Boc...

[uncledudeness]

i feel ya...same here. i spent almost a year on the trial merry go round, but the last one, well i used them. i tried to get into the GlobeImmune GI-5005 trial. i knew i wasn't going to get in, but i got the IL-28 B DNA test done for free. it's a sweet way to get the test done on their dime.

http://216.92.62.193/index.php?load=content&page_id=3

score one for the HepCats....

good luck

[JAY0914]

ya they did one at this trial too...waiting for nurse to email me back that info...hope she does...id like to know..

[Susan_1a_CC]

Hi, I new here so forgive any "stupid" questions...  I just finished the last of my tests for an upcoming trial as of yesterday.  Why were you turned down?  Is your VL too low?  Were you able to ask for the parameters of the trial before screening?  I haven't heard too much about the whole process but from your post it sounds like it can be a merry-go-round of a sort.  Thanks for any info and better luck to you next go round.  

[willbb]

I believe all of the drug companys have certain parameters to be able to get into their study trials.I know the one I am currently in had fairly rigid guidelines.  Age, alt below a certain  #,viral load  above a  certain #  no sign of chirrosis (cirrhosis)  etc etc.

In the end quite frankly I believe the drug companys prefer people they feel will have a better chance of success than not,for the obvious reason,,so they can get their drug approved.

That is always their main focus and sometimes unfortunately their guidelines are quite srtict.

Hope you are approved for your particular study and all the best with it.

[willbb]

sorry  "   cirrhosis"

[Bill1954]

A list of specific study inclusions/exclusions is often available online at:

http://clinicaltrials.gov/ct2/search

For instance, here’s a criteria list for a trial that’s recently been completed:

Inclusion Criteria
• Has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
• Male and female subjects, 18 to 70 years of age, inclusive
• Genotype 1, chronic hepatitis C with detectable HCV RNA.
• Screening laboratory values, tests, and physical exam within acceptable ranges
• Able and willing to follow contraception requirements
• Able to read and understand, and willing to sign the informed consent form and abide by the study restrictions.
Exclusion Criteria
• Subject has any contraindications to Pegasys® or Copegus® therapy
• Evidence of hepatic decompensation in cirrhotic subjects
• History of organ transplant
• History of, or any current medical condition which could impact the safety of the subject in participation in the study
http://clinicaltrials.gov/ct2/show/NCT00627926?term=hcv+los+angeles&rank=17
Enter your particular trial into the search box clinicaltrial.gov and you can go from there.
Good luck and welcome to the discussion group,
--Bill

[JAY0914]

yep its my VL keeping me from getting in....drug companys want you to have 100 k or more before you get in so they can gauge how good their meds work...i think low viral load people may have better chance of clearing but other people say it can be harder for low VL to clear....waiting on nurse to tell me my il28...if its the good one ima do SOC...if its the bad one im waiting for the new PI:s..good luck in your trial and god bless that you kill the beast..it would be like winning the lottery

[Susan_1a_CC]

Good information, thank you.

I glad to be here.

[Susan_1a_CC]

Geesh, you'd think so long as it cleared the virus the drug companies could gauge the response.  Sorry that you missed getting into the study.  I am waiting on my bx result.  The last one I had done was 3 years ago and there was some question at my recent physical as to whether or not I'd get into the study if I was still in as good a shape as I had been.  Oh well, we shall see...

Thanks for the good wishes - I am ready to roll the dice.  Hope that your il28 comes up CC!  

[SusieS2010]

You guys are right about taking the people who have the best chance of success in the trials. That is why the rates of SVR are almost always higher in trials than in "real" life. They often do not count the dropouts either so the "failure to SVR" looks lower than it truly is.