OBETICHOLIC ACID SAFE AND EFFECTIVE AGAINST PRIMARY BILIARY CIRRHOSIS

OBETICHOLIC ACID SAFE AND EFFECTIVE AGAINST PRIMARY BILIARY CIRRHOSIS

Just diagnosed, be aware there is PBC hope, see links below:

2011.04.01 (01.04.2011)

news-medical.net/news/20110...

2011.04.01 (01.04.2011)

USA Phase 2 Study

empr.com/phase-2-study-of-o...

2011.11.14 (14.11.2011)

to last update

2012.07.12 (12.07.2012)

USA Phase 3 Study

clinicaltrials.gov/ct2/show...

USA Phase 3 Study is currently recruiting participants.

UK Medicines Information - New Drugs Online

ukmi.nhs.uk/applications/nd...

Anyone else heard about any of this or have further information?

9 Replies

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  • UK Medicines Information - New Drugs Online link didn't paste correctly, here is the correct link:

    ukmi.nhs.uk/applications/nd...

  • i have read about the testing that is going on regarding this. The opinion it gave me was that it was for people who could not take the urso for one reason or another, but basically is thought it could do the same job.

    I think your alk phos has to be quite high for you to be able to participate.

  • The Trial is for anyone who has been taking UDCA for a minimum 12 months. UDCA meds taken as normal. Substantial decreases in PBC key marker levels. Quote:

    Daniele Prati, EAS's Scientific Committee Member and Press Committee Chairman commented: "It is extremely encouraging to see that OCA seems to be effective in patients from a variety of countries. This is the first treatment trial in many years for patients with PBC that has shown such promising results. Further studies are needed to evaluate the action of this therapy compared to existing therapies and in larger patient populations."

  • I did read all about this and a couple of other studies (one featured in Birmingham hospital newsletter and I think LiverNorth) but with this obeticholic acid as far as I have read, it can cause even more persistent itching it has been found.

    The dosage is apparently being attempted to alter to perhaps rid this side-effect I read further.

    As zipitydoo states tho' I also read that it is apparently for patients who aren't able to have urso.

    Obviously I'm only stating what I have read and understood but I also have read a bit about how studies are undertaken and it can take, think it was 11yrs (?) to actually get to the marketing stage as in it being available for prescriptive use after a trail concludes. Someone else may correct me here but I did find a box chart with the various stages on the internet not so long ago but unfortunately didn't save after reading.

  • Hi everyone

    I did not know if I should post this, as we all know we want/ need and look for some positive news having this terrible disease BUT can I just add a word of caution here regarding this study ( I feel I am speaking as a health care professional with 20 years clinical experience and 12 years as an academic and researcher undertaking a PhD)..................... This study only had 59 patients in it, which is a very small sample size and it is difficult to determine any clinical significance from these result. Now that does not mean they shoud be ignored, or offer us all the beacon of hope we look for, but just viewed with caution at this stage.

    Lets hope they can take the trial to a larger randomised maybe international group of patients to get that critical mass of data needed.

  • Hi EmDee just to add to other comments also have done academic research myself in the past on other subjects relating to health as I am also in the healthcare field (and also have many yrs of experience of patient care under my belt) and hear what busylady is saying re sample size of study being small but that is how lots of research starts with a "pilot" study, i.e. start small, get more people on board, increase sample size=more true findings that's my, (albeit simple), insight into what research is all about. If it helps us or pbc patients in the future I say lets do it but with close monitoring and advise from our hepatologists and gp's. As I am looking myself at perhaps going on transplant list( going for assessment in next 4-6weeks), would love it if sooner rather than later we could get something more effective to help ease symptoms, (my major one is the persistant itch)protect our livers and or better still find a cure pbc other than a liver transplant so we can just keep on " living the life we love and loving the life we live"!. ( Bob Marley). I would just love to wake up one morning and think and feel " ITS ME I'M BACK, YEAH!, and get out there and enjoy life fully which lets face it iis what it's all about. We only get one crack at this thing called life so lets make sure its a fabulously enjoyable one!

  • Nice post littlemo :)

  • Hi just thought I would post to let you know I am going to the QE hospital tomorrow to see if I am suitable for the trial,as my Gastro said I have nothing to loose will keep you informed

  • obeticholic acid is in phase III. The results are expected by summer of 2014. If all goes well (and I think it will), FDA approval can be expected by the end of 2014. The drug shows great promise for those who have not achieved full remission on ursodiol.

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