Clinical Trial

Has anyone heard of the P2938-0721 Pharmasset Clinical Trial?  Any info appreciated!  Also, is there a post or list of questions to ask if one is considering going into a clinical trial?  Thanks!

[Aaron57]

Sorry don't know about the trial .. , but, here are a few question that have been put together for CT's .. imo, a really good idea to do due diligence research before hand as much as possible , and then make an informed decision ...

Here is a initial list of questions for anyone who is considering participating in medical research ie: Clinical Trials .. the answers you might want to know before signing up ... kindly add to it if you have any others that I've missed ... and remember , Clinical Trials are for data gathering , not about the patient ..

Things to ask before participating in a trial :

It would be good to know the Phase of the trial.  The goal of a trial is not necessarily to "cure" people.

In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.


Are Rescue drugs ie: drugs such as epo, GCSF (Neupogen) etc allowed or not allowed and If no rescue drugs are  given ...what action is taken in regards to decreasing Hgb.,whites,platlets etc., and at what levels do they intercede?

Would you have the ability to self pay for rescue drugs if they are needed and not provided by the trial protocol?

What access do I have to lab results during the course of my trial participation?

Will I receive hard copies of lab results, and how are they transmitted to me?


What are the parameters for intervention in the event I develop cytopenia such as hemolytic anemia, neutropenia, etc.

I understand genetic sequencing is generally conducted as part of HCV drug trials to study viral mutation. Will this data be made available to me, and if so, at what time?

What are the statistical odds I will receive placebo in this trial?

For those patients that don’t respond fully to the trial (SVR) will the study drug be made available to them at a later date (roll over program)?

Will participation in this trial limit my future participation in trials and how so?

Who will directly manage my care throughout my trial participation; Physician, NP, PA, RN

How often will i need to come into the clinic?  How long will the appointments take?  Can i schedule the appointments to suit my schedule?

Can I get a commitment to receive any sequencing (population and clonal if available) results done on my virus in the case of failure?  (Push strongly for this given the importance of understanding resistance as best one can.)

When will the study be unblinded (if it is)?

What are the response parameters for determining whether treatment will continue, how long it will continue for, or if it will stop?


Cheers

[gonnabhepcfree]

Is it the called Quantum?  I have been part of another Pharmassett study..you can look at my posts to see how great I have done, There are several people on this Forum that are doing my study. For me the big question was - Did my Dr think I had a good chance with the study drugs to clear the virus permanantly.  His answer was yes and because the rescue drugs were or would have been SOC (interferon and ribavirin) he also said four drugs would/could be better than just two.  I thank G-d so far I have been undetectable since the August 11th and started the study on August 4-and for me other than some fatigue in the beginningand some weight gain- NO side effects.  Having worked as a plebotomist at the VA Medical center for many years I was in contact with people, before, during and after treatment and because of that it scared me out of treating until my Dr said the time had come to treat.due to the results of my biopsy..That being said I had the virus since it was called non a, non b, over thirty years.

[curiouslady1]

Yes.  It looks like Quantum.  And I assume you are going to be doing it under a PI like Stu Gordon.  That would be awesome.  He is a real pioneer.  I went to him about 20 years  ago but didn't qualify for the study then because of my thyroid.  Gonna b, myself, and a couple of others on this forum have been involved in a conjoint trial with BMS and PSI.  I have been at UofM.  We are all getting terrific results so far.  I wish you well.  Please stay in touch with us and the forum and let us know how you are doing.  

[UKgirl55]

If it's the Quantum trial it's PSI 7977, PSI 938 and Ribavirin.

I believe one arm is all three, one is 7977 and 938, 7977 and Riba, a placebo arm and one 938 monotherapy arm.

[Michigan57]

Thanks everyone for your input and comments.  Screening won't start for a few more weeks and hopefully I'll be one of the lucky ones.  I'll keep you posted!

[curiouslady1]

Michigan57,  Sorry I read in your intro that the trial at your site has been closed.  But there are arms on a previous Pharmasset trial that are being added I understand.  You may want to get in touch with one of the sites listed with NCT01359644 because they say they are still recruiting.  I am not sure about UofM as no one has mentioned it but the new arms being added was just mentioned today.  

http://www.dailymarkets.com/stock/2011/11/04/new-12-week-interferon-free-treatment-arms-added-to-all-oral-combination-study-of-psi-7977-and-daclatasvir-bms-790052-for-hcv-genotype-1/

[Juttutin]

Slide on page 19 of http://files.shareholder.com/downloads/VRUS/1479878974x0x501016/559fb290-7e4e-4297-9e56-5daa79b0793f/Corp%20Presentation_UBS_91511_2.pdf

has a nice graphic showing the PSI Quantum trial broken into the various streams.  Much easier to follow than described in text.

There are other presentations at http://investor.pharmasset.com/events.cfm that show the other PSI trials in similar formats; including the Phase III and extended Phase II trials, but you sometimes have to dig around a bit to find the ones you're interested in.

[UKgirl55]

Have they started to open up a trial for PSI-7977 and TMC-435, or did that already open and close? Come to think of it, wasn't it for nulls?

[candyce1953]

I was going to try for that study but chickened out when read about the different arms
And about possible viral tessostance in general

I think what you said was very helpful
I think I would rather be in a later study
Don't have time to mess around have hep c 40 years never treated
Trying to decide which TX to do
Am afraid clinical studies could waist valuable treatment time
Speaking of which
Which do u suggest
Vertex or merck
I can't decide?
Thank you

[curiouslady1]

I had hep C 40 years too and a starting VL of 13 million.  After 1 week of treatment with a drug having a high barrier to resistance, my VL dropped to 70.  After the addition of another drug I was undetectable 5 days later.   What is viral tessostance?

[curiouslady1]

Unfortunately, I don't think Michigan57 is checking the site much.  I was hoping to get her attention by sending a private message but she is not set up to receive messages perhaps because it is a work email.  Anyway, hopefully she will find her way.  

[Aaron57]

Maybe the most important deciding factor to Tx or not .. or with what drug , or to wait for a clinical trial that you are comfortable with ... to me ...

What is your liver condition .. this should be determined first. It's possible , even though you have had the virus for a long time , that little to no liver damage has been done .. on the other hand your liver might have been affected ...
Have you had a biopsy or any tests to determine your livers condition ..

At my age 54, if I didn't have boarder line F3 liver damage .. I would wait .. but, that's not the case for me ... I'm doing the old Tx , started last Nov. long before the new drugs were approved .....

Since what I read is that both new drugs have about the same success rates for folks like me .. because of my unique situation (we all have unique situations) , I know I would not do 24 wks Tx even if I eRVR .. I would probably choose 36-48 wks Tx & probably choose to try Boceprevir .. it seems to have less severe Sx ... if I had to start now ....

This is a very personal decision ,one you should make only after doing some real data digging and after consulting with a HCV specialist ...

Hope this helps , Aaron

[Michigan57]

Sorry I haven't been on her for a while.  The phase II trial I was talking about ended up getting filled before it reached Henry Ford Hospital ... so I'm back on a waiting list and hoping to get in to phase III if my dr.thinks I can wait.

[Michigan57]

Aaron I'm 58 ... geno 1a, stage 2+ fibrosis ... started off with a Gastro dr. and am now seeing a Hepatologist (Dr. Gordon) at Henry Ford Hospital.  I go to see him again in a few weeks for new blood work, etc. and will see if he thinks I can wait for something to open up. I have low platelet issues so even if I started on Bocevir or Teleprevir there is a chance I'd get pulled off of them, whereas with this particular study, my platelet count wasn't an issue.  I'd really like to try something that doesn't include the interferon and it seems like even more new drugs are on the horizon.  Thanks for all of the info you're sharing with me.