Speaking of Clinical Trials

[C-FIGHTER]

This really is amazing! 

Speaking of clinical trials, does anyone have any experience participating in a trial?

I am currently trying for one, but I have not heard anything back. I really don't know  what to expect as far as being contacted.  the clinical trial is currently recruiting and in my area. 

 The trial  is simprevir and sofosbuvir in combination for 8 or 12 weeks.

anything that can be shared about this  or your experience would be most appreciated. 

Thanks
Janice

[lporterrn]

Hi,
I was a clinical trial nurse at Stanford and I also participated in a hep C clinical trial (now hep C free), so I'd say I know quite a bit. Here is what I know:
1) Getting in to a study can be very competitive. The people who are more likely to get called back are the ones that are as organized and ready to go. Have your medical history, labs, copy of biopsy, medication list, etc are ready to go and this gives you an edge.
2) Be gently proactive. The polite, persistent, squeaky wheel helps you get attention. Don't overdo this - a call or email stating what you said in this post is an example of something gentle but proactive. Ask if they might know when they are starting, and if there is anything they need from you to help secure a spot in the trial.
3)If they say no, ask to be put on a waiting list. Tell them you can step in any time. Thank them even if they say no. Despite having worked at Stanford, I was denied a spot because they were full. Someone was disqualified at the last minute and the next day I was in the study.
Here is some more info to help: http://www.hcvadvocate.org/hepatitis/Basics/Clinical_Trial.pdf
Hope this helps.

[C-FIGHTER]

Lucinda,

Thank you so much for replying.  I have read your book "Hep C treatment, one step at a time."  I loved it. You have been through so much with this disease as have many Hep C survivors. I am aware of your history and the fact that this treatment at Stanford was your third go. You have been  to hell and back with Interferon and Riba. I am happy for you that you finally slayed this dragon. Congratulations!

I do appreciate your advice, and I had a feeling that it would be very difficult to be selected for this trial, and others. I do have all my records in order and I am ready to go.

I have not been contacted or called yet for even that first step yet.  I have talked to no one at this point.  I submitted  my questionnaire ( 5 questions) nothing deep at all last week.
I am thinking that they do not contact everyone that submits a request to participate in the trial.  Would that be a fair statement?

Thanks,

Janice

[lporterrn]

Hi,
First, thank you for the nice words. It means a lot.
Second - did you go directly to the institution that is doing the trial or did you go through a middleman? The 5 question questionnaire makes me wonder. Did you sign a consent before sending that in?  I'll answer your question when you answer mine.
Third, I am writing about this in my blog on Hep on Tuesday. I am expanding on this.
Here is some more info: http://www.hepmag.com/articles/hepatitis_clinical_trial_21799.shtml
Lucinda
 

[C-FIGHTER]

Ok. to answer your questions, I did not go directly to the institution because I have not been provided with that information.  I do believe I am going through a middleman. The only truly relevant question that was asked of me is have you been diagnosed with Hep C? One of the questions asked for me to select the location which was most convenient for me or to my liking. I did "agree to terms" I don't think that would be a consent. I am going through patient.services@sylogent.com.

I look forward to the blog on Tuesday.  Thank you again
Janice

[lporterrn]

Hi Janice,
These are not exactly scams, but they aren't patient-centered. These sorts of companies are sometimes looking for subjects, but often they are just looking for data. In short, I'd be surprised if they actually place you in a clinical trial. I am sorry to be so skeptical, but I see a lot of this. Do let me know if I am wrong - nothing would make me happier.
Lucinda

[C-FIGHTER]

Thank you Lucinda.  I believe you would know.

I do feel disillusioned though, this was through clinicaltrials.gov.  I thought that would be a trust worthy site.

oh well.

thanks again
Janice

[lporterrn]

Ah, I did not realize that it began there. This may pan out. Would you send me the link to the actual study you clicked on?

[C-FIGHTER]

http://clinicaltrials.gov/ct2/show/NCT02114177

Thank you Lucinda.

[lporterrn]

That one is completely on the up and up. It is completely reasonable to follow up with an inquiry. Sometimes these things take a long time (weeks or even months) BUT it is all too easy to fall through the cracks.

You can also look at the areas listed at the bottom, go to their websites, see if the study is there and see if you can find a local contact.

[C-FIGHTER]

Thank you so much for all your trouble to help me with this.  Just to know that it is on the up and up, and what to expect wait wise, helps me to understand how to proceed, and when.  I am not surprised that these trials do take awhile to get off the ground.  So I will be patient and cautiously optimistic, that I may get a call. At the same time I will try to find some other way of making contact after some time goes by.

You have been a big help, thank you so much!

Janice

[optimystic]

i had applied to two trials. received an e-mail back informing me that enrollement had been filled . they "sylogent" posted on e-mail the  www.clinicaltrials.gov site. yea.... at least i received a reply. KEEP on TRYING. me too.

[hopefulguy]

New to the forum here.  I participated in a study starting last August, thru my GI & hospital.  Trial was for Lambda Interferon in conjunction with Ribavirin and Telaprevir. 66% got Lambda, unfortunately not me.  I won't bore you with the details, but I will say that despite the failure after 20 weeks, I would do it again, maybe even with Interferon if there were some additional drug that had a reasonable chance of success.

The downside of a study is that you don't really know how you are doing relative to the virus, until it's over.  You can make some assumptions, but that's about it.

My doctor is getting me squared away to start Sovaldi and Olysio.  I have my fingers crossed that I can get this combo.  I've heard of remarkable, nearly unbelievable results for patients that have flunked out of Interferon treatment.

If you have any other specific questions about my clinical study, please ask.

Good luck to you, and everyone
Bill

[optimystic]

what i do like about www.clinicaltrials.gov, is that when a trial is complete, you can see the posted results. i had to study them a little while to fully comprehend what i was looking at, and you can see the study expectations, time frame results as to dosage, percentages making an acceptable svr, any side effect related incidents, etc. you can select a trial that used any meds you would like to research. this was very helpful in my decision making. remember this is your body, and you are at the mercy of the effects. but keep in mind that we all respond differently, and not all meds are for everyone.

[Mike]

I think the real data will come this month as 1000's of us have finished treat and are awaiting the 12 week end of treatment results. The clinical trials were based on very small sample sizes (200-300 carefully selected participants).

Shortly, there will be data on 10's of 1000's of us for the researchers to cull through.

Many, many efficacy studies will be available on all types of populations (diabetics and SOL+RIBV-INTF tx, for example).

This is exciting and, although the clinical trial participates blazed the first trail, we're the pioneers!

Best wishes, Mike