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Avatar universal

Has Anyone Did A Trial Study ?

Since the cost factors is high, I thought I would ask the nurse about a trial...where the treatment is free, so to speak.
She said that there was  some trials coming up and that I should really consider it.
There are some trials I found on the Liver website:  Can anyone help me understand them?  I don't want to go into a trial and receive placedos...the nurse said that it would not happen...I don't know if I fully trust them, yet...

Here's the info off of liver website:

1.
CPG10101 Combination therapy for the treatment of hepatitis C: a phase 1B open-label, randomized trial of CPG10101 alone, with interferon, ribavirin,

The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called CPG10101 (Actilon- a toll-like receptor 9 antiviral agonist), when it is combined with pegylated interferon and ribavirin, for patients who have relapsed during previous treatment attempts.

2.
Peg Intron plus Rebetol vs. Pegasys plus Copegus for HCV patients with genotype 1 who have never been treated with any interferon or ribavirin product

Two different doses of Peg-Intron plus Rebetol will be compared to standard doses of Pegasys plus Copegus.

3.
PEG-Intron/Rebetol vs PEG-Intron/SCH 503034 With and Without Ribavirin in Chronic Hepatitis C HCV 1 Peginterferon alfa/Ribavirin Nonresponders: A SCH

The purpose of this study is to evaluate the safety and effectiveness of an investigational protease inhibitor when it is combined with pegylated interferon and ribavirin, for refractory patients.



8 Responses
87972 tn?1322664839
Hi Mari;

Take a quick look at:
http://clinicaltrials.gov/
for current information regarding clinical trials. According to U.S. NIH, the trial you mentioned (CPG 10101 Combination Therapy for the Treatment of Hepatitis C), has been completed.

For the most part, clinical trials will provide excellent overall care at no cost to the patient, but you
Avatar universal
I have done a study before, many years ago, back in 1997, with the original Intron-A/Ribavirin trial, back when Riba was in the clinical trial process.  I'm investigating trials right now, don't know if I'll even be considered with all the times I've treated before w/o responding.  Anyhow, you never know with a clinical trial, in the early phases....some of the trials use placebo.  If you have the time to wait until the later phases, they stop doing the placebo thing.  It just depends on what stage/phase the clinical trial is in.  I'm not real thrilled on doing a placebo trial either.  On the other hand, from what I've read with this one group I've looked at, you get a really, really, thorough physical, EKG, liver biopsy, drugs paid for, every labwork you can think of, all paid for by them.  But, there is always the risk factor, testing a drug that's not been FDA approved yet.   For me, personally, I am praying about it.  I really don't know what the right thing is for me at this point, so I'm trusting the Lord to either open the door for me on this one, or close it if it's not his will for me right now.  
Susan
Avatar universal
as you said the tx is NEVER
Avatar universal
I was on the higher doses on a couple of my treatments.  My doctors at that time, based their decisions on other studies.  I was given prescriptions under the 'off-label' way that doctors are allowed to prescribe.  The insurance did eventually cover it with the doctor's phone calls, but I had to pay a higher co-pay.

Susan
Avatar universal
sorry hit the wrong button.

tx is never free. 48 weeks of your life will be invested. these can not be gotten back.
if ,if ,if you really need tx now this may be an out. i got free drugs from plough shearing ,,,thank you p/s,  because of my income. please do not base your decision to tx only on free drugs but on your need to go forward NOW  only.

THE # 2  choice is like the diference between asperin or tylenol. not a big differance in svr rate. 46% over 48%?

number 1 or 3 choice is still 48 weeks? if you need tx now go for it. but be informed of your options. a year from your life is not to be taken litely.
bobby u
Avatar universal
I just talked to my NP on Thursday about a Roche trial and whether it was a good fit for me. It is for people who weigh 85k or more. Earlier this week Grand Oak had given me a link to learn more: http://www.roche-trials.com/patient/studies/cat10617.html

NP said that the up side of the above trial, is that I could possibly be dosed at a level his office would not. So that would be plus and yes, everything paid for, no copays or anything.

One down side is that all treatment HAS to happen at the trial site, you can't go to primary care for any labs, or concerns, anything. So if you are a distance from the trial site, it is something to consider. I don't know if this is true for all trials, but I am sure someone can chime in.

Anyway, he is going to have the trial nurse call me to set up sending additional information, consent forms, and a pile of other paperwork for me to go over. I don't have to commit to anything to go over all the stuff.

For me personally, since this study doesn't have any new, cutting edge drug, just higher levels of Peg and riba, I am curious how people get the higher doses of meds that I am reading about here on the forum (and does insurance cover it, if the doc will prescribe it)?

Double Dose? Anyone, anyone?
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