Getting into trials

[mike716]

I am 64, in good overall health, recently diagnosed with HCV, genotype 1b, still have pretty good blood markers, and am probably a good patient for drug trials.

I know about the NIH trials website, but it isn't patient-friendly and takes a whole lot of time and trouble going through it and then trying to contact the people doing the trial, maybe for nothing. With hundreds of trials going on, I could spend the next year looking for one.

I'snt there some central trials clearing house for patients, where you can offer yourself and see what trials are interested in you?

[FlGuy]

Not sure if this is the site you're referring to.

www.clinicaltrials.gov

Go to Search and key in criteria like      hepatitis, miami

Based on the inclusion/exclusion criteria listed, you may be able to narrow some of the trials you'll be eligible for.

[mike716]

Thats the site. I don't understand why they make it so difficult to find a trial to get into. After all, they need us as much as we need them. There's gotta be a better way.

[Forseegood]

hi, it's been my experience that clinical trials doesn't always note every  trial  offered everywhere...if I were you, I'd call, or better, go personally if you can... to all the teaching hospitals in your area (after all, I highly doubt that you'd join a trial that isn't in your area, though some do go out of their immediate radius, I had a friend who took flights to San Francisco VA because he didn't like the VA in Los Angeles, said SF was much, much better) to see if they have anything coming up...

the trial coordinators (ask to speak them right off), or nurse practitioners for the hepatologists/gastros *usually* will be forthcoming, at least that's what I've encountered...good luck to you...also, I'd ask for their criterion upon entering a trial, but I've even heard that some docs will let you bend those a little bit too in some instances....though certainly not always....just my take...

[FlGuy]

Depending on where you live and the various facilities that might be in your area it might be helpful to actually be seen at one of the clinical trial hotbeds.  I had a consult at one of those university type settings quite a while ago.  Since that appointment they have called me about my interest in trials on 3 different.  After that consult they decided to list some characteristics and, apparently, they refer back to it every once in a while.

[mike716]

Both sound like good suggestions. I'm going to find out where trials are being done around here in New York City or on Long Island (I live in Queens, NY), and go and talk to someone. Maybe I can get into a local patient database, or at least find out on a face-to-face level what's available in my area.

I'm new to this and it's all a little confusing. Thanks to both of you for your help. If you know of anyone in this forum who's from my area, please let me know.

[hippygem]

Try this link to find trials, its really good
http://clinicaltrials-dev.ifpma.org/no_cache/en/myprotal/index.htm

[hippygem]

Doesnt look like it is going to work, the only other way I can suggest is to go to www.hepcaustralia.com.au and go to the 'Links' section and you will find a link called 'clinical trial portal', click on that and it will take you to it.

[jt57]

If you are in New York, I would call Dr. Ira Jacobsen with the Hepatitis C Center in NY City.  I actually called to make an appointment with him, that is how I found my DR. here in Charlotte.  And I am about to start in a study trial in 4 wks. for naive treatment 1b's.  Maybe they can tell you where you can get in on this in your area.

Jean

[jmjm530]

Forgive me for being presumptuous, but unless there's a lot more to your story you may be putting the trial cart before the horse.

Your first step is to see a liver specialist (hepatologist) for a full evaluation to help you determine whether treatment is the right course for you at the present time, as treatment advances keep getting better every day.  This may include a liver biopsy to determine how much liver damage you have or don't have.

Then, once you have been properly evaluated, and if you decide you want to treat now, then you can look into ongoing trials in the area as an option.

Two excellent liver specialists in your area are Dr. Ira Jacobsen group at NY Hospital  (he personally does not take insurance) and Dr. Douglas Dieterich at Mt. Sinai Hospital. Both have more credentials and experience than a Gastro for proper evaluation, and both are involved in major trials.

-- Jim

[nygirl7]

Mike may I ask why you are so gung ho to get in a trial? Trials while they do pay for almost everything I believe do have some shortcomings such as you don't know which arm you will be put into (for example susan400 received vertex and inteferon but NO ribavirin and treatment can't work without the riba) so it was a waste of time for her.
Also, usually they won't let you have any of the rescue drugs.......and believe me if you need to get Procrit you will want it badly.

Is there some reason that you aren't going to do current SOC and see how that goes? I had both geno 1A and 1B and did 72 weeks of treatment and am SVR now 15 months post treatment.  It can work.

Debby

[mike716]

Both URLs worked for me. Thanks. The IFPMA website looks like just what I was looking for.

[mike716]

Hi, Jean. I'll give Dr. Jacobsen a ring on Monday. Good luck with your trial in Charlotte. Please let me know how it goes, or keep this forum posted. You and I are the same genotype and both of us are naive to treatment, so your experiences of the trial are of very real interest to me.

Mike

[mike716]

That's okay, Jim, nothing presumptuous about it, you're quite right, I am jumping the gun. But my situation is kind of unusual. I'm a New Yorker and I have an apartment here in Queens. Two years ago I went to Argentina for dental work (lots of implants and such), and I've been down there most of the time having that work done. It's very inexpensive there and some of the dentists are quite good.

Since I'm down there a lot, I got a health plan at a local hospital. Two months ago I came down with some kind of intestinal trouble (still to be diagnosed), and the gastroenterologist sent me for extensive blood analyses. That's how I was diagnosed HCV+: from a  from a routine blood test. I'm not in one of the recognized risk groups, so no one ever did an HCV antibody ELISA on me before.

I've been seeing hepatologists in Buenos Aires at my hospital and they are putting me through a lot of tests. I have to go back on April 25th for an endoscopy and an ecodoppler, looking for esophageal varices (a marker - and one of the worst consequences - of cirrhosis, so they tell me), and then probably a biopsy. The hepatologists there figure I was infected from a blood transfusion when I was a teenager, so they naturally expect me to have more or less advanced liver disease after carrying the virus for forty-five years.

I have no complaints about the doctors I'm seeing in Buenos Aires, the trouble is that they aren't equiped with the latest test equipment and there are no trials or new therapies there. I want to see what's happening here, in the forefront of HCV research. Also, there are no support groups in Argentina, and I don't think I want to try and handle this alone.

Anyway, I hope that explains why I'm putting the cart before the horse. Just trying to get information about treatment here in the U.S. (where I have no health insurance).

Thanks a lot for your suggestions. I appreciate them.

Mike

[mike716]

Hi, Debby. Well, I wouldn't say I was exactly gung-ho on a trial. I'm just sort of information-gathering, if you know what I mean. Checking out my options. And I have some specific ideas about what sort of trial I would want to get into. For example, there are some interesting alternative therapies. If it turns out from the tests that I'm still stage 2 or even 3 and I don't absolutely have to go on antiviral therapy immediately, I might want to volunteer for a trial of combination silymarin-naringenin-glycyrrhizin (botanicals), or some other alternative therapy for controlling liver damage.

So don't worry, I'm not going to volunteer for any trial where I might get put into a control group that's not receiving the full treatment, like what happened to your friend susan400. I'd take my chances at the hospital in Buenos Aires (see my post to jmjm530) before I'd do that.

Congratulations on being SVR for 15 months! Sounds like you are beating it. That's very good to hear, believe me.

I didn't know they were doing 72-month treatments. The literature all says 48 for 1b. Did they give you 72 months because you had both 1a and 1b?

Mike

[mike716]

I tried the IFPMA trials search using "hepatitis c" and "new york" as my key words. It gave me something like two hundred responses. When I clicked on the first three it came back with "Study Enrollment Completed".

This is what I meant about the trials websites not being patient-friendly. Seems like we're expendable. There are so many people with hepatitis out there, I guess the drug companies paying for the trials figure they don't have to treat us with respect.

Maybe I'm better off getting treated in Argentina. At least we're human beings down there.

No point in getting too pissed off, though, huh? It's late. I'll try again tomorrow.

Mike

[nygirl7]

First off I did go to Dr. Ira Jacobson for a second opinion myself - I don't think you can find a better more compassionate brilliant man in the universe.  when you meet him you see how very far onto the cutting edge he really is (he is the lead investigator of many of the big studies going on today) and how much he has dedicated his life to helping us. If I could have afforded to go to him I would have - however he is such a wonderful man he called my hep doc and offered to assist him in my case for free. Wow.

I originally set out to do 48 weeks too.  Unfortunately although my viral load plummeted down right away to only a count of 411 - at week 12 I still had that count left.  Because I hit a plateau and did not reach Undetectible until somewhere between week 12 and 24, using both the Berg Study (which Dr. J was principal investigator of) and the Spanish study - Sanchez Tapias - I took all that info and realized between the two studies it was saying that if I extended to wee 72 I had much better odds of beating the disease. In fact it went from like 50/50 to 1/3 chance I would relapse. Those odds were much better that I could clear so I went for it.

That's the great thing about the forum. We all share all the information that we dig up and discuss the HECK out of it and start to formulate plans that some doctors who aren't current on reading the new literature would come up with.

My doctor understood what I was saying but he wasn't a big shot so he sent me to Dr. J. and said that he should be the one to decide.  Dr. J. said if I wanted to know at the end of the day I'd done everything I could to push the odds into my favor the most I could that it was a good idea to extend - so I did.

These days now a lot of people are starting to extend treatment and it's becoming pretty much common if you aren't clear by week 12 but you are by week 24 to do 72. It sounds dreadful but really by that point in treatment you've already conquered the biggest side effects and are pretty much level so you just keep going.

I wanted this disease DEAD so I just went for it.

Hang around here and learn as much as you can. With this disease the more you know the better chance you have of being CURED.

God bless and good luck Mike!
Debby

[jmjm530]

Sounds like your cart is where it should be, albeit the horse appears to be Argentinian :) Touching bases with a U.S. based medical team sounds like a good next step, especially since you have an apartment near some of the best hepatoloigsts in the world. An appointment with Dr. Dieterich and/or  Dr. Jacbobsen will not only put you in touch with cutting-edge HCV thinking, but with available trial information as well. Also, if you do decide to treat in Argentina for other reasons, you could use the U.S. doctors as consults via phone or email.

-- Jim

[Mary4now]

Hey Mike,
Did you mention if you had a biopsy and what the results were?  I didn't see it as I ran through the thread,  Thx. M4now

[mike716]

Thanks very much for all the useful info on extending. When I have to make a decision, I'll remember.

You sound like a very brave person. I hope I can be as brave when the time comes.

Mike

[mike716]

I like your idea of consulting with Jacobsen and/or Dieterich from Argentina. That's what I've been lacking down there, someone to check with. I'll definitely be calling them on Monday.

This forum is great. Everyone is very supportive. For the first time I don't feel alone with this thing.

Mike

[mike716]

Hi, Mary. No, I haven't gotten to the biopsy yet. The hepatologist who's been assigned to my case at the hospital in Buenos Aires wants to do an endoscopy and an ecodoppler first. He's concerned about what they call esophageal varices, which, if I understand it, are enlarged veins in the upper alimentary tract, caused by cirrhosis of the liver, that can hemorrhage. He's probably had some experience with patients having that problem. He says that if they find varices they will put me onto antiviral therapy straightaway without a biopsy, because then they will be sure I've got advanced stage liver disease.

Everyone I've seen at the hospital down there figures I got the virus from a transfusion I had when I was eighteen, and I guess they think that after all these years my liver must be pretty bad, whatever the blood tests show. I'm hoping they're wrong.

I've seen a lot of doctors, including some at other hospitals in B.A. and even a private practice hepatologist. I want to get a lot of different opinions and as much info as possible. Some thought I should have a biopsy right away. I argued it with the hepatologist assigned to me and he convinced me to wait for the endo and the eco.

Apparently quite a lot of work is being done to find ways of testing the liver for disease without doing a biopsy. By hunting around on the web, I found some info about a new non-invasive test of the liver that uses an optical scan, by computer, of common tomographic images. The people who developed it (in Spain) claim that even a biopsy doesn't show the whole story because it only gets tissue from part of the liver, and sometimes the damage is in other parts. For what it's worth, here are some URLs about this new method of imaging the liver:
- http://www.ncbi.nlm.nih.gov/pubmed/18098299?dopt=Abstract
- http://www.hcvsinfronteras.org.ar/index.php/2008/01/25/mtodo-para-cuantificar-la-fibrosis-sin-necesidad-de-biopsia/
- https://www.isotrol.com/web/contenido?pag=/contenidos/capacidades/subseccion_soluciones/Fibrotac

The first link is to an abstract in English of the article on it in Hepatology magazine.
Unfortunately the second two websites, which are easier to understand, are in Spanish.

Maybe this is all too technical, but since I'm being put through a lot of tests I figured I ought to find out about them.

Sorry for the long-winded answer .

Mike

[HectorSF]

Mike, you say your blood markers are still good? How is your platelet count? Your platelet count can be a good indication of cirrhosis and portal hypertension which leads to the varices which you mention. I know from personal experience, as I am genotype 1 and have cirrhosis with portal hypertension and am taking meds for my varices while taking the standard PEG/COPEG treatment.

Cirrhosis - Platelet Correlation:
Cirrhosis (scar tissue in the liver) causes portal hypertension (high pressure in the portal vein)....
Portal hypertension cause the Spleen to enlarge and causes esophageal varices....
An enlarged spleen traps platelets. (Platelet count begins to drop) A low platelet count causes blood to not clot properly.

Remember a biospy is still the gold standard for determining the status of your liver. It's not a big deal to have done in the scheme of things you will go through in treating your HCV and the information obtained is invaluable. Remember, viral load, genotype, and biopsy results are predictors of your chances of clearing the virus (SVR). Depending on the status of the above data (including the stage of your liver disease determined by biopsy) can mean the difference between having an 50% chance (genotype 1 & healthy liver) of clearing the virus or a 10% chance (genotype 1 & cirrhosis plus portal hypertension)! This will have a huge impact on your expectations and course of treatment! Also by monitoring your vl over the first 12 weeks of treatment you and your doctor(s) will have a good indication of your chance of clearing the virus in the long run.

Best of luck which ever way you decide to treat your HCV!

Hector

[mike716]

Hi, Hector. Thanks for the info on platelets/cirrhosis/varices. I had two platelet counts from two analyses, one done in 2005 and another done recently. The one in 2005 says 192,000. The recent one says 156,000. I guess they are going down, although a number of websites give 150,000 as the limit of normal. Maybe I am at that limit now. Or maybe it's normal to go up and down.

I'm slated for another platelet count at the end of April. It'll be interesting to see what it says.

As to my blood markers,  they aren't normal but they could be worse. That's what I meant by pretty good. My ALT is around 59 now and has been the same over the three years that it's been measured (hepatograms were done on me as a routine part of blood tests before I was tested for HCV). The AST has stayed around 43. The GGT has varied between 85 three years ago and 40 recently. Weird. The worst is the bilirubin, which over the three years has stayed around 2.0, twice the upper limit of normal. Still, I guess it could be a lot worse.

These are not big increases, according to what I've read. But the NIH and Mayo Clinic articles on HCV, and what some of the doctors have told me, is that slightly elevated levels are the norm for chronic hepatitis C and that they don't correlate with liver damage.

There are other blood markers that are important according to my hepatologist, but I don't know what they are. The doctors in Argentina are very traditional and conservative and don't want to tell patients anything. They don't seem to realize that making a mystery about it just increases paranoia. But I do get a copy of all the test results, which is something, anyway.

Oh, and ecographs (ultraound) were done on me in 2006 and also again recently. The 2006 one says slight increase in size and density. The recent one says no abnormalities. Go figure. Although one hepatologist I spoke with told me that the size of the liver goes up with fibrosis and then down again when you get to cirrhosis. If that's true then these ecograph results aren't worth much.

Frankly, all these markers seem so ambiguous that i don't see how you can tell much of anything from them. Of course, I'm just repeating what I've been told or read somewhere on the Internet, you understand. I don't really know anything about this stuff. But it does sound like there isn't really any way of telling how bad my liver is without a biopsy or something equivalent. Which is why I'm interested in the new liver analysis method I mentioned in my answer to Mary4now, above.

Hell, I see my posts here are getting longer and longer. I guess I'm getting a little carried away. It's exciting to finally have some people to talk to about this.

Time to hit the hay.

Mike

[Mary4now]

"esophageal varices, which, if I understand it, are enlarged veins in the upper alimentary tract, caused by cirrhosis of the liver, that can hemorrhage. He's probably had some experience with patients having that problem. He says that if they find varices they will put me onto antiviral therapy straightaway without a biopsy, because then they will be sure I've got advanced stage liver disease. "

I would think you would have some symptoms if you had advanced stage liver disease, and when they discover that you do not have the varices, then you will have a biopsy?  The hepatologist I saw is a transplant hepatologist and he said that sometimes the virus does not do as much damage, and that the biopsy is indicative of the entire liver.  
Your blood work doesn't show disturbing levels and the ultrasound can also show how the blood is moving through the liver indicating whether there is fibrosis.  
I hope you will keep us posted and best of luck to you.  It sounds like you have alot of resources to see you through this let us know how you do, and what resources were most helpful..   best wishes