Applying for Clinical Trails info

[gerard11]

Can anyone comment on when they we're  trying to get in a clinical trail GS-7977. Were their any  exclusions  or inclusions besides what clinical trail.gov  listed.  Was anyone turned down or not eligible for any reason other than the stated reasons?  I have heard moderate fatty liver disease could be a disqualified ( not listed).  I have not seen that posted on clinical trails.gov. We're any prescribed meds not compatible with the trail. Was location ever a Reason for disqualification?  Looking to clarify any  non listed potential exclusions before I start applying .  Was a wait time of other treatments a problem ( like resent non responding  thriple thearpy tx).

[gerard11]

Hector pm

[HectorSF]

Yes, there are things you can be excluded for but I wouldn't spend time worrying about it. That is why all patients are screened first. Then it is decided whether you qualify to be part of the study or not.

For example in the exclusion section of my GS-7977 + Ribavirin clinical trial as listed on Clinicaltrails.gov doesn't say is to be excepted into the trial you have to have a total bilirubin < 3.0. Trial specifics are contained in the small trail book that the coordinator has. It is not for public consumption.

"We're any prescribed meds not compatible with the trail. "
Yes, of course. If it is thought that a drug could skew the data then you must stop the drug. The Rifampin that I was treating my TB with the day I started the trial, I had to stop. Again the people running the study know this and plan accordingly. It is all part of the screening process.

"Was location ever a Reason for disqualification?"
I don't see how location could affect it unless you don't show up for your follow up visits. Then anyone would be removed from the study anyway as the data would be unless.

"Was a wait time of other treatments a problem ( like resent non responding  thriple thearpy tx). "
You will see that listed at Clinicaltrails.gov.

"Looking to clarify any non listed potential exclusions before I start applying."
As I said there are at least dozens of exceptions that I could never how known relating to blood levels and other medications for my trial. To try to guess is impossible and a waste of time. The reason the info is posted on Clinicaltrails.gov is for patients to find what may be an appropriate for their situation. It is the job of the Clinical Research Coordinator and the person running the study to determine if you are qualified or not.

Of all of the GS-7977 trials. Most patients don't qualify for more than one or at most two trails that I can see. Also trials are only at certain locations which narrows it don't further. What any patient should do is find the most appropriate trial based on their hepatitis and liver disease and apply, unless like me my hepatologist who is leading the trial here ,calls you to ask if you are interested.

I see 6 recruiting GS-7977 trials.
I see 5 not actively requiting GS-7977 trials.

Of these trials they have different requirements based on  a patient's treatment experience, genotype, coinfection with HIV and degree of liver disease.

Keep in mind as more trials progress to phase 3, many slots will be open for patients.

Don't over think it my friend. If you need help, I can help you with the process. Or contact some of the other folks on the forum that has been or are now in GS-7977 trials. Here are posts from those of us using or having used GS-7977. You might ask your question again there.

http://www.medhelp.org/posts/Hepatitis-C/GS7977-Study-Patients-Here/show/1769198#post_8473921


Cheers!
Hector

[rivll]

I was almost excluded due to cirrhosis, but I got lucky.(That was when GS-777was in trial with Pharmasett.)
As far as wait time goes, I had to wait 3 months to be retreated.