I will be talking with my hepatologist next Friday about a clinical trial he will be conducting. All I know is the drug is from France. He says he is very encouraged with their results so far. I have a few questions for him, but I’m hoping some of you who have been in trials might help me with a few questions to ask. I know I would have to be off Ocaliva for 3 months. Not too keen about being without my drug that long. Any help will be appreciated.
Thanks
Gail
A trial for GENFIT,: Elafibranor, is in trials in Europe and the US, for PBC so perhaps it’s that one.
Maybe have a read of : clinicaltrials.gov/ct2/show...
It may help prompt questions. I guess if it were me and I was given the placebo, I’d want to know if there would come a point when I’d be put back on medication, if there were any worsening of my bloods from being off OCA. Hope all goes well.
Thank you. I will definitely read up on it. Have a great day!
I think they are in the phase without placebo
Oh that would be nice. Are you familiar with the drug?
I understand that the drug Rifampicin is not so effective when it is restarted after stopping. I would want to know if Ocaliva has that same effect or if there are any other known side effects for stopping ocaliva and starting again. What if you end up in the placebo group what are the disbenefits to your liver. Having raised the points contarily being part of clinical research is an amazing thing to do for you and the wider community . Let us know how you do.
Great point. I’m at work so I’ll get back to you later today 😊
So, I have wondered how being off ocaliva would affect my liver. At this point we’re not sure it is helping me. When he discussed the biopsy results, I asked if he thought it wasn’t working. He said it could be that I am one who progress faster naturally, so it isn’t necessarily ocaliva not working. I feel like I’m in a round room looking for a corner. Ocaliva is my only option for now.
That is exciting news. What are the qualifications to be a part of it?
Stella❤
I’m not sure. When he first discussed the possibility, it depended on if I met criteria. So maybe I’ll find out Friday. I suppose I meet it.
That would be Elfibanor from Genfit
Thank you 😊
And that is the one Candy12 mentioned as well.
I researched it. From all I read, it failed. So I’m hoping it’s not that one. I won’t be involved in that one.
It failed in its trials to address NASH, but they are doing new studies for its use for pbc.
biospace.com/article/genfit...
With the failure, elafibranor joins a number of other experimental drugs that have been unable to crack through and achieve regulatory victory in NASH, a metabolic liver disease estimated to affect more than 16 million people in the U.S. alone. Last month, the FDA issued a Complete Response Letter to Intercept Pharmaceuticals for its NASH treatment, obeticholic acid.
GENFIT said the decision to terminate the Phase III study is the first step of a new corporate strategy that includes a renewed focus on developing elafibranor in primary biliary cholangitis (PBC), a chronic, autoimmune disease in which bile ducts in the liver are gradually destroyed. The company called PBC “an exciting opportunity” as the market is expected to reach $1.5 billion by 2035 and remains an area of high, unmet need. Elafibranor showed promising results in a Phase II clinical trial for PBC and was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration for this indication. GENFIT’s clinical team is focused on the launch of a Phase III study.
Yes, I did read about that as well last night. I will let you all know after I talk with my hep on Friday. Thank you 😊
I did go back and read my article from genfits website. I should have kept reading and I would have seen the positive for PBC. Sounds promising. 🌞
Just diagnosed with PBC
unanswered questions
Finally seen Hepatologist
Pbc and cholesterol bumps
