Clinical study

[Fisheress]

This is a clinical study I am thinking of applying for.  Does anyone think it is worth a shot at?

This study is currently recruiting patients.

Sponsored by

Hoffmann-La Roche
Purpose

The objective of this study is to evaluate the efficacy and safety of Pegasys in combination with Copegus given for 16 weeks versus 24 weeks in previously untreated patients with Chronic Hepatitis C virus Genotype 2 or 3.

Condition  Treatment or Intervention Phase
Chronic Hepatitis C
  Drug: Pegylated Interferon alfa-2a in combination with Ribavirin
Phase IV


MedlinePlus related topics:  Hepatitis;   Hepatitis C


Study Type: Interventional
Study Design: Treatment

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Age greater than or equal to 18 years
Infected with Hepatitis C virus Genotype 2 or 3
Exclusion Criteria:

Pregnant, breast-feeding or male partners of those who are pregnant
Hepatitis C virus Genotype 1, 4, 5 or 6
Previously treated with interferon, pegylated interferon, ribavirin or viramidine at any previous time or any other systemic antiviral therapy or investigational drug less than or equal to 3 months prior to first dose of study drug. Exception: Patients with a limited (less than or equal to 7 day) course of acyclovir or valacyclovir for herpes more than 1 month prior to first dose of study drug are not excluded.

[silvermoon]

Thanx so much to both of you!  all f you..
I am actually from St Pete, originally, seriously thinkin about JAX area.  Have a great week!

[cindee]

Hi Carol, When I spoke of my "goofy" doctor...my 1st...he was liver and GI. I really liked him as a person. We got along very well...he did always take the time to really "listen" to me. Now that I look back, I think I put too much TRUST in him. Sometimes I think he "listened" to me, to LEARN from ME!!! After I found this forum, I would go for office visits, armed w/ paperwork, numbers, etc. I really can't blame him for my relapse...I just didn't think he should wait 6months post tx to re-check blood work. I kept calling his office and telling the "head" nurse, who was truely a "witch"...not my reg. nurse...thank GOD...about how BAD I still felt. Her reply was to call my GP, "you shouldn't be feeling so bad after you've finished tx." Well, after not ever getting through to my doctor "goofy"...my husband stepped in and demanded a 4 month blood test. The paperwork was at the front desk the next day...to have my blood work done. We waited almost 4 wks and never heard a word from my blood work. Sooo hubby and I were in town...(I now live in SC, and had lived in NC before getting re-married, so all my doctor's were an hour away)....we had been to my pain specialist and decided to stop by "goofy's" office, to get the results of my blood work. It was almost lunch time, and as we pulled in and got outta th' car..."miss receptionist" was on her way OUT TO LUNCH!!! She stopped us in the parking lot, and she came up to us and looked @ me and said, "you RELAPSED". I thought my hubby was gonna DIE! He said you mean to tell me, YOU have the nerve to tell us this in the parking lot???? At that we walked away. This was early April...and to this day, that doctor has NEVER contacted me with words of concern or anything. I guess long story short...just because you "like" your doctor...because you can talk easily to him...is NOT ENOUGH!!! I found that out the hard way. I wish you the best....I'm gonna e-mail ya! If you're in Charleston and are willing to travel to another doctor...I am about 3 hours away from Charleston.....I'm gonna e-mail ya now. Sincerely, Cindee

[cuteus]

yes, dissecting the study is a good idea if you know what you are doing.
by the same token, just because a study used 9  patients and 8 out of 9 got svr (all geno 1), am I to dismiss it because it is only 9 subjects? Yet, most drs do.  When you don't have that much to work with  from the start, you take whatever you can find, and that is where us geno 1's find ourselves.
stay well

[Sam Hall]

I have noticed that a lot of youre posts refer to studies and research and i spend a good deal of time doing this in another field.Drugs for mental health problems.After what seems a lifetime i always start with suspicion of methodology and with filtering of volunteers. With Peg-interferons the results seem to be so statisticaly small as to be virtually meaningless. All of the research relys on patients complying to dosage(Riba especially) and their behaviour re drink/drugs during trials. I know when  it comes to it this is all we have but surely there is one stat that counts 0 over 100%.
Sam

[silvermoon]

well. it found it's way out of cyberspace I see..
thanx for the note.. yes, I  try to present what I have researched, their response is that they hate when patients mention  the internet.. seems they'd rather we know nothing.. less complicated for the,m..I just want soemone who is at least willing to listen and look at what is brought to their attention. it seems that they get 'set in' and don't want to try anything new..but then, all this is fairly new and thankgod, it is changing and Tx is hopefully getting better and better with new discoveries.. I try to present info as," While I was researching, I found this... what do you know about it and what do you think?" or, "This is my concern, this is what I have learned, what is your opinion or knowledge of it".  There aren't alot of Dr Ben Cecil's out there...who are willing to think outside the box..
again, Thnax so much.. have a wonderful day...Carol

[silvermoon]

hmmmmm..... I answered your posts.. but it is lost in cyberspace I guess..too tired to do it over.gotta go to bed now...maybe tomorrow I will recompose it.. thanx for the notes though..really appreciate it....night all..will keep ya's in thoguhts and prayers.. take care..Carol

[Sam Hall]

When i was diagnosed it was done by accident ,receptionst told me youre fine. Saw theGpand he grovelled. However i went out and researched everthing i possibly coul. Now wheni see my consultant igo armed with print offs of any research ithink is needed or they say they haven't heard before. And i get my own way most of the time. Be in chrge but friendly with it. Don't make a consultant out to be dumb,just busy.
Sam

[silvermoon]

hey again.. Thanx for the support! means alot!..  as far as potassium, I keep an eye on it.(symptoms). I live on fruit..so not to worry..but, that's another thing.. he orders meds, but not regular bld work to follow.. makes me NUTS!!
and no...even though we have the Medical University here.. medical care is not great..infact, nurses  tell patients to go out of state for treatment for things.. and alot of docs, like mine.. would never think of sending a pt. to MUSC for a transplant..even though they do them.. and the HepC clinic follows their protocol and theirs only.. forget even asking questions or about extended Tx here!! Bow down to the doctor gods...
I have been in Chas since 1976, since I graduated nursing school..and I am over it .and it is expensive to live here... I am soooo ready to move away.. just have to figure out where..and since I have this evil disease, that, and medical care plays into where I move!!  that and the fact that I want to be near the ocean and where it is hot and sunny,,, but don't know that I will get all 4 of those..;)
  I have alot of thinkin and plannin to do in the next couple of weeks..
  wish ya'll the very best.. Thanx to all for the info.. will keeps ya's in my thoughts and prayers.. my eyes are blurry.. tired, so I am going to tell my computer good night for now.. enjoy your day!  take care... and keep smilin'..Carol
  PS.. Does anyone out there know of any legit jobs doing computer work from home no matter where you live?? Having to travel some would be fine, but mostly need to work from home..  I am pretty good with the cmptr..but it is so hard to find companies that will let you work from home.  I have to get more money coming in to make it.. will be doing some ebay stuff, but that is hit and miss. SORRY.. I know this isn't the employment office.. but, have run out of ideas..and it can't hurt to ask..right??   email: ***@****     thanx...

[cindee]

Hey all, TY so much for the prayers, and concern when I was ill these past 2 wks. I saw my GP Friday. He said I had a stomach virus, I was just HIT HARDER...because of my hep c . He gave me 2 meds...protonix, 1 a day...and phenergan 12.5mg...1 ...3X's a day. I haven't thrown up in 4 days now. YEAHHHHHHH!!!! But don't feel much like eating yet. I m eating a little...not to worry! I hope I will feel much better each day. Thank you ALL again. You ALL are the BEST!!!!!! love @ prayers, Cindee

PS wishing you all a good week-end w/ little to no sx. (((HUGS))

[cindee]

Hey you, I am so sorry you feel so unfortable w/ your doctor. Are there any hepatologists in Charleston????? I think I would be looking for another doctor...before I start tx. My 1st doc was a "goof"!!!!! Now I have a hepatologist and he is a straight shooter!!!! I feel so at ease w/ him...and I trust him because he ONLY does Hep!!!! I will start a trial w/ him in Oct. I relapsed after 4months post to 48wks of combo tx. I don't know if I told you already, but I was an EVR...and undectable thoughtout tx. My 1st doctor only treated for 48wks. I was so "dumb" about hep c until I found this wonderful forum. I now feel if I had, had a GOOD doctor that would have let me treat longer, I may not be going thru this trial. But life goes on. And I do believe GOD has his hand in my fight! I've said before, maybe I relapsed because I am a FIGHTER, and I AM ONE who needs to go thru a trial, not just for me, but for others as well. I wish you the best and I will be praying for you. Love @ Prayers, Cindee

[jonihs]

As long as you are on lasix, they also need to keep an eye on your potassium. The aldactone(spironalactone-generic) doesn't take potassium out, but the lasix does. Both my sister and I very nearly had heart attacks from low potassium while on lasix.
  Joni

[silvermoon]

??? What do I mean?  I mean that I am not feeling terribly confident in the coordination b/t my doctors and in the Tx and the way they will be handling things.  When I ask a question about something, his answer is usually, "well, we don't do anything about that until it gets very progressed"
I asked about lactulose for 'brainfog'..   he said that I wasn't that bad YET!  I asked did he look at my ammonia numbers.."no"..  I feel, that if it is a problem to ME.. then it is a problem to be dealt with now!
I asked about the fact that my thighs swell up more than 10" their normal size with fluid when I stand for a few hours or sit too long..(blood pressure goes up about 45 points,too.)  he said, it wasn't bad enough yet..that I didn't have ascites..that my abd. was fime..but my thighs looking like oak tree trunks and veins popping out all over wasn't a problem for him..
My other doc, internist, gave me lasix...SHE noticed that my blood pressure was way abnormal for me...it worked great.. then the Hep doc ( he is an Infectious Disease specialist, NOT a Gastro dr.)finally put me on aldactone. and lasix in addition when needed..
I asked the internist about what lax to use just to clean out good.. she gave me a script for lactulose..and after using that a couple of nights, the fog isn't as bad,,
  I fell lousy most of the time..exhausted..weak...
up until last summer, I could walk 20 miles in the heat without breaking a sweat! I am used to being active 20 hrs a day..doing 10 things at once,running 2 or 3 business at once.. handling everything myself... now a trip thru the grocery store wears me out! I have never felt older than about 30.. and look much younger than my age (turned 50 in Dec).. but I feel about 80 right now.. and I am NOT accepting this for my life!
In Nov '03 I went to 3 Government Mule concerts in 5 days and didn't stop dancing from beginning to end without missing a beat..and ready for more.. now, I'd fall out in a hour tops..IF that long.  then I'd be in bed for the next day or two from exhaustion...
...another thing that bothers me.. I told the Hep doc that I started feeling really bad last summer while staying at my sisters in FL.. knowing I have asthma and chemical fumes set it off.. she was spray painting furniture with Kilz and paint in the room next to mine for several weeks... I was hacking , wheezing and coughing like crazy.. she didn't give a damn...I started feeling really drained afterwards...and extreme nausea set in also abd pains.. a few months later I went to a doc and they did tests and said I had cirrhosis.
My Hep doc here said that the chemical fumes wouldn't bother my liver.. only if I orally ingested the chemicals.. but I think he is WRONG!
SOOOOO.. you see.. I am just NOT feeling real comfortable starting Tx with no consistency! kinda like.. they are just doing a routine, no variation,  and not really listening to the patient!! I used to be a nurse.. so maybe I am pickier than normal..I believe patients are PEOPLE not a disease.!!
sorry so long..  and Thanx for your interest!   Take care...Carol

[donAlfonso]

Cuteus, thanks for the info from Dr. Cecil.  Next time I see doc (2 weeks) I'll ask him about dose increase.  Guess I should check out his website and look for more info on this.  Thanks again.

dA

[silvermoon]

Thanx...  I am not afraid to ask questions.. and have been as well as doing lots of research.. just could remember what was up with the eye thing...
I will be doing this pretty much alone.. so I really need to know everything upfront.. Seriously thinking about going to Jax,FL to the Mayo Clinic..My doc says he will send me up north when he thinks I need to look at transplant..but I am wondering if I should get an opinion from those specialists NOW before I do anything else..??
Ya'll all know that starting Tx is scary anyway.. so part of me keeps telling myself that that is all it is.. but the other part of me say s I am not out of line in this.  I do have Pt rights..and as long as I am of sound mind, have a right to decisions about my Tx.. right?  I was starting to feel good about the fact that I finally got to go to a doctor again after 4 yrs of no medical care... but  I am not as enthusiastic now.  something is not sittin right with me.. and I know that I should always heed my instincts!!  whatcha think?

[silvermoon]

Thanx..  My doctor has Tx lots of HCV..but seems to only follow standard protocal as far as Tx time..
I LIKE him as far as being able to talk with him and his 'bedside manner".(( I have seen a couple who were.rude and didn't seem to give a rats ass about the person/patient.))..BUT..I AM having to fight to use Pegasys over the other one..seems he only uses PegIntron..from S-P.  I don't think it is right for a dr to use only one companys' products..
.I can't have a biopsy because my platelets and PTT won't budge in a positive way..Radiologist said it was too risky for me. (I have posted on this before).. and he will use Procrit, etc..has me seeing a Hematologist already..but.. OVERALL.. I am not happy with his methods..because, from what I have been told by his nurse.. they do 24 or 48 weeks..done!
I am going to call Mon and ask to have an eye exam..I have so many things on the downside already with my blood and cirrhosis..I DON'T need anymore problems.  
I am wondering how much Tx will actually help as far as turning some of the liver damage around or at least halting it..  WHY go thru all the sides of Tx, if I am going to have to have a transplant either way?  my VL was only 373,00 in April, down from 1,780,000 in Jan..and have had no Tx yet.
I appreciate being able to get others experiences, opinions, research, and sides tips on this site.!!  not to mention the encouragement and laughs provided!  Thanx! and wish you the best.. Carol

[TnHepGuy_]

The baseline eye exam is to check on the health of your eyes before beginning - so that if you have anything crop up at all during tx, they can go back and see where things stood to begin with and use that as their comparison (there are rare cases where tx can cause severe eye problems). Some docs don't order them. I would push hard to get one done.

One of the most important things you can do before beginning treatment is to present your doctors with all the questions you have for them regarding what THEY do (e.g. - do they intervene pro-actively with Neupogen and Procrit BEFORE reducing dosage, will you be getting a biopsy done beforehand (I would push hard for one), baseline eyeaxam, do they do extened treatment for those who are 'slower' responders, how many Hep C patients have they treated, etc).

It's the only way to find out if your docs are knowledegable and experienced enough to treat you - and if they are willing to work with you during the course of treatment. If they don't - and you have the option - look elsewhere for one who will. It could well be the most important decision regarding the potential successful outcome of your treatment.


TnHepGuy

[silvermoon]

shorter Tx for g2and3..sounds great!  good luck with it!
and who knows.. maybe it will lead to shorter Tx time for 1a & b?
?????...please... what is the deal with the eye exams?  TnHepGuy, you mentioned this in your post..
I remember reading somewhere that it should be done, pre-Tx.and the docs I was going to in FL(before I came back to SC) said it was mandatory, as was a shrink exam, in their practice.. But here, it seems hit and miss..I asked my docs office last week why I haven't been scheduled for an eye exam..his office said they are cost conscious and don't do it unless you are having eye problems!..besides not being 20/20 vision anymore and alot of blurry vision..that's it..  Frankly, I am starting to feel uneasy about how "disjointed" things seem to be with my drs.and that is not a good feeling to start Tx with..
  I believe it is easier to prevent a problem than to treat one..   Anyone want to jump in here?? any info or opinions appreciated!  Thanx!

[TnHepGuy_]

A few things you may want to find out about the trial before beginning it:

- if you are a 'slower' serum/viral responder and don't clear as quickly as they are looking for, will they allow you to extend to 24 weeks - or beyond, without stopping the treatment? (you'd hate to have to do this stuff more than once).

- what level(s) of ribavirin will they be using?

- will they intervene with Neupogen for low white counts and Procrit for low red counts? If so, will they intervene pro-actively (i.e. - will they give you it BEFORE they lower dosage)?

- who would pay fop the Neupogen and/or Procrit? Who would pay for any other medications you might nedd during the course of treatment?

- how often will they be giving you a PCR? and other blood work?

- will you have access to your PCR and blood work results as you are going through tx?

- who will be monitoring you during the course of your treatment? a doctor or assistant who is part of the trial? or your own doctor?

- who do you call in case you have questions to be answered? during treatment?

- will you need to have a biopsy before beginning? sometime after ending?

- will you be given a baseline eye/retinal exam before beginning?

- if you will be doing any measurable amount of traveling - will you be reimbursed for those or any other expenses?



The SVR odds for geno 2's doing a 24 week course are approximately 93%. For geno 3's doing 24 weeks it's approximately 80%. If given the choice of doing a 24 week course having those odds or doing 16 weeks and quite possibly lowering them - I'd definately go for the full 24.

Either way you chose, best to you as you begin your treatment.


TnHepGuy

[jonihs]

Thanks for the heads up!! It will definitely be on my top requests for doc next mo.   Joni

[mycoldfeet]

I have been reading everything I can find on new drugs on the market, especially those for geno 1's. I was an early responder but, I guess the little critters were smarter than the pegasys and mutated, and came back...but that ns3 protease inhibitors by whatever name each company is giving it sure looks promising...zero viral load in 48 hours...impressed me. Now that is a clinical study I'd like to be in before any damage to my liver does occure. I am patiently waiting for some further progress to be made. I was surprised at the injections of mistletoe and green tomatoe extract....no **** its in trials now. I would like to know how they would think up that combo...well if anyone hears of anything coming up yell. but in the meantime take a look on your search engine on either one...makes for interesting reading. yall have a great day and a better one tommorow.

[Fisheress]

You all have been so wonderful!  I wish the best to you all and know that I have found the perfect forum for the support I am going to need.  Again thank you & God bless

[silvermoon]

Hey. I believe the Shp-saiko-to study was/is being done by Sloane-Kettering Hosp in NY..(or NY Univ Hosp.)but I think S-K.
I spkoe with soemone there early this year.
Also.. does anyone know anything about Dr Wei de Ren @ NY Univ Hosp and his treatments? here's the link, if anyone wants to look into it:
http://www.dr-ren.com/index.htm
Have a great weekend everyone..

[jonihs]

Having just completed 24 weeks a couple of mos. ago and having the last half be really rough, I'd go for it in a heartbeat. I was clear at 12 weeks. Good luck!!!! Joni

[MichaelT]

The risk is you have to retreat for 24 weeks, but the pay-off would be gloriously wonderful if it works - I did 48 weeks as a type 2 and I can assure you there is a whole world of problems that begin after 6 months of treatment. Shorter is worth the risk.

God bless!  -Michael