What constitutes "chronic liver disease"?

[katla]

I noticed  on clinicaltrials.org that exclusion criteria often include "chronic liver disease" and not quite sure if this would refer to me.

My biopsy indicated grade 2/stage 2 which indicates fibrosis. My fibroscan, unfortunately, was 17 which is consistent with cirrhosis. My doctor seemed a little surprised that the fibroscan was so high since he already had my biopsy results. Aside from HCV I don't have any other liver disease that I'm aware of. Would these results preclude me from the trials? ie would these results qualify as "chronic liver disease"?

Thanks.

[HectorSF]

What trials are you looking at? Give an example.
If you have had hepatitis C and liver damage you have chronic liver disease.

"chronic liver disease" "a disease process of the liver that involves a process of progressive destruction and regeneration of the liver parenchyma leading to fibrosis and cirrhosis."

Hector

[jsf52]

Hi, What I've learned from Hector and others is to look closely at the inclusion and exclusion criteria of each trial.  For example, the Gilead GS9451/GS5885/Tegobuvir trial that I am in required a liver biopsy within the last 3 years that indicated an absence of cirrhosis.  As my biopsy from 2010 showed me to be a Stage 3 Fibrosis, then it was acceptable for the trial.  There is some great information on this site about questions to ask when looking at clinical trials.  Good luck.
jsf52

[katla]

Thank you both.

Hector-
Sorry I wasn't clear in my post. The exclusion was  "any other clinically significant chronic liver disease", i.e. other than HCV.

Take the Atomic study as an example with PSI-7977 with PEG/RBV  (id#NCT01329978).
It states:
__________________________________
Inclusion Criteria:
  Males and females with Chronic Hepatitis C (HCV) Genotype 1,4,5,6, or   indeterminate
Naive to previous HCV treatment

Exclusion Criteria:

    Positive for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
    *History of any other clinically significant chronic liver disease*.
_____________________________________________________
so here are my questions:
1. Since my biopsy indicates grade 2/stage 2 which is consistent with fibrosis would that preclude me? i.e. would fibrosis constitute another "clinically significant liver disease"?

2. Since my fibroscan is 17 which can be interpreted as cirrhosis, would that preclude me?

3. Do you think my doctor could  just present the biopsy results? (and ignore the fibroscan score)?

I found some mention online that very high fibroscan scores can be due to  alcohol - i.e. the scale/score is different if it's just due to HCV or if alcohol factors in,which would be consistent with my alcohol fueled past, but there's really not much info on that.

Another problem is that since my doctor sometimes conducts trials he will only want me on a trial he's involved with which seriously limit my options.  He happens to be involved with the Atomic trial which I found online but he never mentioned it to me although he told me he'd call me when something became available. I'm really frustrated!!!

Please don't hate me for this long, rambling post...promise to be more concise in the future.

Thanks so much ❤