question

i emailed roche about possibly getting in a trial they have going on. they emailed me back saying i needed my physician to contact them.the trial shows a place where i live but says not yet recruiting..i was wondering if they do the trial as an outpatient with my own doc?

also the drugs used is r7128 plus SOC in 5 different arms with only one arm being the placebo..phase 2
is anybody on this trial now and have any feedback?

thanks in advance for any info?

[nygirl7]

No trials are strictly controlled because they are trials....they need to document and take extreme caution that all of their protocols are met.

Most doctors are willing to help their patients get into a trial if there is a reason for it.  Can't you ask for his / her help?

[JAY0914]

thats what i will be asking him....thanks NY

[FlGuy]

I would take a guess that the trial location is University of Texas Health Science Center, Houston.  That's based on the clinicaltrial.gov for the 5-arm trail that you referenced and a little other googling. So, if you wnt to dig a little further get the phone number for the Hepatology Clinic at UT-Houston and ask to speak with the 'Trial Coordinator' .  Tell the coordinator a little bit about yourself (briefly) and express your interest in that particular trial (by it's description and number NCT00869661) and your availability.  If it's affordable, schedule an appointment for a consult appointment.  That way, you are on their radar.

I did such a thing a a busy hepatitis trial place and over the ensuing months I got several phone calls from them asking if I had interest in various trials.

[JAY0914]

your exactly right on the location...thanks for the info so much i will pursue this further with it..

[Isobella]

That's exactly what I did....found the centers running my trial and then let them know I was interested.  At the time they weren't recruiting yet either, so it did take some time...but I felt it was worth the wait.  

Good luck to you!

Isobella

[FlGuy]

When you think about these trials you need to keep in mind what the motivation of the trial site doctors and clinic are.  They get paid (variously by Pharma, Gov etc) for landing guniea pigs, lab rats and guppies.  In addition the docs get published, admired by their peers and most of all quoted in places like MedHelp if they are really lucky. So, when a qualified trial subject falls into their hands it reduces their search, sourcing efforts and costs. If it's a trail for which you have interest and for which you are qualified, it's a win-win for everyone involved.

That's also why it's a good idea to understand your normal doctor's affiliations and connections to larger universities and organizations.  They are the normal 'feeders' to these trials.  Putting yourself 'out there' make you more readily identifiale.

[JAY0914]

thanks for the info fig....lab rat hmmm how true...unfortunately my doc is a GI who prolly does not have any connections...i did pursue that University of Texas Health and science and it shows no trials there so it must be somewhere else..i just called and left message at Texas Liver Coalition in houston and they show they are having a trial...hopefully the r7128 one...been wanting to wait til telepirvir comes out...but same time i want to get these monsters out of me...even though i prolly have time to wait being a stage 1 grade 2...the mind thing of having it is driving me crazy...thanks for info...

[newleaf09]

I got into a trial because my daughter emailed the clinic doctor, who she had briefly met before and he said I should call him.  I told my own doctor out of simple courtesy and he was fine with it.  Someone else recently posted that they went for screening to a clinic that was just anticipating starting a trial later.  I never felt like a lab rat.  I had the nurse's personal cell number so I could text or call her if I needed advice.  Knowing my own doctor's staff, I would never have been able to get such prompt expert advice from them.  My doctor does not publish because he is not the principal investigator on the study.  He does have an inside track with the trial people, though, which is useful. It all just depends on the protocol of the study and the staff at the individual trial sites.

[JAY0914]

that Texas Liver Coalition just called me back...pretty quick response..she got some info on phone and wants me to fax my reports in to her. she said there are several screening for trials starting end of october and to call her back by then if i didnt hear from her before then...kinda feels good getting soething started in the direction to killing the monsters...she was pretty impressed with my knowledge (thanks to the experts on this site) hopefully when they call my number i will get a chance with a good drug...

[FlGuy]

That's quick action.  It's surprising sometimes how a little research can payoff. Just a little tip; when you talk to this people it's always good to display a level of knowlede.  A well informed patient is usually someone who will be compliant with protocols.  Just be careful about references to 'internet forums and chat rooms'.  Seems like medical folks are not impressed with 'too much knowledge'.

[newleaf09]

Definitely don't mention forums and chat-rooms.  Instead say "A freind said".  I found that it took a really long time to impress upon the study staff that I was intelligent and knowledgeable about my illness and treatment.  It took months of asking for copies of my labs before they started having them ready for me at visits.  Many study sites are in teaching hospitals where they tend to deal with people who never have questions or curiosity about the process.  It's wonderful that you got in touch with so little hassle, after all.  Be sure and call back if they don't get in touch.  They can have up to 50 trial patients per site (in addition to non-trial patients) and their workload is very heavy on clinic days.  Good luck!

[maxygirl]

I am in one that started Sept 4 and they have been very good to me.  I started with a viral load of 6.9 million and today it is 70.  All my other blood work is normal and they give me EKG's every visit.  My side effects are minimal at this point.  Headaches mostly. I went to a hepatologist on my own after finding out I had Hep C...My family doctor said to wait but I had to know more so I asked for a referral and the hepatologist said it is not about whether you treat or not but when as it doesn't go away and it may be much more difficult if I was ill.  Everyone here has been so kind to me also.  I bravely give myself the shot just as they assured me I would.  Thanks

[banarep]

I am in week 32 of the telaprevir trial (got the meds) called the study hospital in December, they called back in January when they were recruiting, got them all my stuff and bamb, I am now UND and have not incurred any costs - they are paying me......

you do want to find out about labs, etc.  my trial will not release any lab information on viral load until 2012, I know that since I was on meds, I had to have a Vl of <100 at week 4/6/8 and 12 to continue and then be UND by 24.  My own doc gave me a viral test at week 20 and I was UND then - if I had known no lab results, I would have gone to him earlier.

[Isobella]

~~~~the mind thing of having it is driving me crazy...

I can totally relate. I was so stressed with the whole thing before starting tx, that when I finally started, the relief was so great, I almost didn't even notice the sx, lol!

I've loved my experience as a lab-rat.  My care has been excellent. I hope the same holds true for you.  My hepa was very optimistic about the trial you mentioned.

Just be very clear on the guidelines and protocol for your trial.  If you have any questions, make sure you get clarification.

Good luck,

Isobella