Cenicriviroc Clinical Trial For NASH - Anyone Enrolled?

[LeiL]

Allergan picked up its lead NASH program, cenicriviroc, in its 2016 acquisition of Tobira Therapeutics. The drug had just failed a phase 2b trial in NASH, missing its primary endpoint of reducing a measure of fatty liver disease activity—called the NAS score—by two points. However, it delivered on one of two key secondary endpoints: improving fibrosis by at least one stage without the worsening of NASH. With regulators’ support, Tobira decided this should be the endpoint of cenicriviroc’s phase 3 program. And after inking a deal that could be worth $1.69 billion, Allergan is carrying the trial forward.

Also called CVC, cenicriviroc is a once-daily pill that blocks two chemokine receptors, CCR2 and CCR5, which are involved in inflammatory and fibrogenic pathways. The phase 3 AURORA study aims to enroll about 2,000 patients with NASH. The first part of the study is pitting CVC against placebo in NASH patients with stage 2 or stage 3 fibrosis, according to ClinicalTrials.gov. The second part of the trial will zero in on patients with more severe disease—that is, those with stage 3 fibrosis. Allergan has also teamed up with Novartis to test CVC in tandem with the latter’s FXR agonist tropifexor in a phase 2b study.

[Ednoral]

Nice to know that they are working on some medications for this disease.

[Alterity]

Yes, I am on the study with Ohio State University. I was told they hope to have it approved within the next year. I believe I am on the right pill and the Dr. things so too. I was in stage 4 fibrosis. 18 months ago. My swelling is down, no pain in my right side at all. Resent ultra sound showed stable. I have a Fiber test the end of August to check elasticity. I feel so much better, although the pill really tired me out and the Dr. said probably because the liver is working so hard to clean itself up. I was told I was the last person to be put on the study before they shut it down. I'm on month 5, of a 12-18 month study. I was diagnosed with NASH in 2001 and given 6 years to live. I'm still kicking. 64 years old. Was told I had fatty liver in 1983, but no one did anything about it, if only there was a way to cure it back then. I really feel my dad died of NASH, but never checked for it, they just said it was a heart attack. Well the liver failure probably caused the heart attack. Good luck everyone. Pray this is the cure.

[LeiL in reply to Alterity]

They are now recruiting for phase 3. I’m reluctant to get a biopsy.

[Alterity in reply to LeiL]

I had one several years ago and then I had one for the study. They put me out the second time, first time was very painful. I was happy to have it done though because it only tells them more about my liver. I had discomfort for about 3 weeks afterwards, but anything to find a cure for so many people. I could be saving my kids lives with this research and I feel if I would turn for the worst, they have all my testing done, I'd be first to get a living liver. They talked about living liver with me before I went into the study, but I feel great now.

[3331 in reply to LeiL]

Get a biopsy done well worth it. Find out what is going on.

[LeiL in reply to 3331]

Had one done years ago and I was in pain for 6 months from the incision. I really don’t want to injure the liver more.

[Wainsworth in reply to LeiL]

I had a liver biopsy in January that was not bad at all. I had no pain and it was over in about 5 minutes. The worst part for me was worrying about it before hand, and you have to lay on your side about 2 hours and then back for about an hour and then you are done and you go home.