Drug trials

[janejulie]

Hello , been to see my consultant and he said my liver as got worse and that they have a pbc nurse at the hospital who is doing drug trials. As anyone been on a drug trail for PBC

[Hidden]

Hello janejulie.

Sorry to say that I've not (though I have thought about this previously) but there are some on this site who have as I have read their posts/replies previously.

Did your consultant say what drug trials? If you check out on the NHS website by clicking on the link I've posted and searching out PBC it should come up with what is being trialled currently or what is recruiting which you'd require.

I know one that has been completed and apparently about to be marketed in the USA is for OCA that is another component of bile that is going to be used for anyone non-respondent to urso or if it seems to have stopped being of benefit for the PBC.

Another thought perhaps try putting the word 'trials' into this search on here, it might just show up previous postings for you.

nhs.uk/Conditions/Clinical-...

[Kevviv]

Hello janejulie yes I have been on a drugs trial about 2 years ago the first one to do it at Newcastle (my claim to fame ) lol. But still have not recieved results yet, wether I had the placebo or the real drug I don't know. But I am due for checkup next week so may get the results.

[mollymom in reply to Kevviv]

Fabulous.. we're testing a promising PBC medication for those that don't respond to URSO here in in USA, given approval to come out earlier than usual has been very promising... My adoptive Mom also from Newcastle, so that's my claim to fame too!!!! she came to USA after WW11 and adopted me, when I was 6 months old... Greatest woman EVER,......survived all the bombings in WW11. Great Britain... you ROCK!!!!! Best of health to you PS. I don't care what people say... My only MOM was not biological but I consider myself to be half British... Bring me some blood pudding LOL Kevviv! Yes Peridot comment correct Drug about to go on sale here in the USA very very good in the trials seems to work great on the PBC!!! YAY good health to all!!!

[masc0t]

I had exactly the same thing happen to me in January this year. I think I must've passed some kind of threshold with my results, which then prompted them to offer the trial. I have just completed the trial in Newcastle, at the RVI. I have one last appointment to attend in a few weeks. Which drug trial are they recommending and where are you located? I have heard that those who do drug trials do better in the long run for several reasons: you have a full work up and any other issues/secondary issues are picked up immediately. And you will be better connected with your own health care and self management which can only be a good thing. I was also given a card to carry showing that I was on a drug trial, so if ever I attended A&E or similar, I would be prioritised, even if it did not appear to be related to your liver or drug trial. I was told from the beginning that I would be receiving the drug and not a placebo (I think that this trial had progressed beyond that stage). But please feel free to contact me if you have any questions.

[janejulie in reply to masc0t]

Hello , nothing yet as they said i have to wait for the PBC nurse to ring about it , am in Medway in kent . Am hoping that i might get bit more support then you do from the doctors . I was on the urso but it made my stomach really back , Did you have any side efforts from the new drug you tried?

[kimphoebe]

Hi janejulie

Yes just starting one soon been through the screening process. I have had pbc now for 4 years and been told I'm a nonresponder to the urso

[janejulie in reply to kimphoebe]

Hello Kimphoebe , i kept telling my doctor that the urso was making me in a lot of pain with my stomach when i was taking them , how did you have to wait to go for the trial

[kimphoebe]

Not waited for long maybe a few months. If it works it should help with quality of live. It only for 3 months but if it helps for a little while that would be great but it a big commitment. A lot of hospital appointments and for me that a 280 mile round trip.

[masc0t in reply to kimphoebe]

I think I must be on the same trial. One day per week at hospital for 3 months. I admire your commitment, I only had 5 miles to travel each way and some days the journey felt like it went on forever.

[kimphoebe in reply to masc0t]

Start on Tuesday think the travelling be the worst part I think. My husband has to take time off work to drive me there. So a commitment on his part aswell.

[masc0t in reply to kimphoebe]

Are you going to get your medication by infusion (drip)?

[kimphoebe in reply to masc0t]

Not sure but I would have thought so because they check bloods before and after.

[masc0t in reply to kimphoebe]

I found that where they put the drip in (top of my hand) was uncomfortable. Couldn't straighten my hand as it dug in, couldn't bend my hand too much as it dug in. I took a stress ball so that my hand would have some stability and support in a relatively comfortable position. Take as much or as little as you need to keep yourself occupied and comfortable. I took my own fleecy blanket, Kindle, magazines and laptop. They gave access to the wireless so that I could get online. After the infusion, I felt quite tired so slept for the rest of the time (hence blanket). You will get compensated for travel, don't forget to ask for claim forms. Please feel free to ask me anything

[kimphoebe in reply to masc0t]

That's nice to know. Will keep you updated thanks

[Karaliz]

Hi janejulie. I'm from Australia and have been on the OCA trial for nearly 4 years. As the other posters have noted this drug will be available soon. Great to be recruited into a trial if you can.

Good luck.

Karaliz

[Pat_H]

Yes, I went on a trial at Queen Elizabeth Hospital, Birmingham. I had a couple of periods of 3 days at the hospital, when lots of tests were taken, interspersed with weeks at home when I took either the trial medicine or a placebo. I never knew which. I enjoyed the trial, I found it really interesting and had no side-effects. The only minor problem I encountered was that I had to give up taking Questran for a couple of months and, during that time, my itching increased exponentially. That was just over a year ago, and I don't appear to have had any nasty post-trial after-effects.

My only moan is that I have no idea what the results of the trial are - or even if they have finished the trial yet.

[mollymom in reply to Pat_H]

I don't know if this trial you were in is the same med here in the USA had such great results.......It was granted approval to come onto market much sooner than it would usually take. My Liver specialist in NYC was running the trial here in NYC. She said it looked very promising, It should be on the market here very soon....here is the USA it is rare that the trails don't last a few years...but this med had such good results it was put on what we call the fast track for approval by our government drug approval agency called the FDA. So if it is the same drug that was in your trials, it may be very helpful to non responders to URSO....

[Pat_H in reply to mollymom]

I really don't know what has happened to the drug programme where I was part of the trial. The trial was called LUM001-2001 and was a "Phase 2, Randomized, Double-Blind, Placebo-controlled Study to Evaluate LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi) in Combination with Ursodeoxycholic Acid (UDCA) in Patients with Primary Biliary Cirrhosis".

Apparently it worked by stopping the bile travelling around the body after food digestion. The surplus bile, instead of trying to get back into the gall bladder via the bile ducts but not succeeding, is channelled directly into the small intestine and thus out of the body.

During the just over six week trial, when I took the drug or the placebo for two weeks at a time, never knowing which I was taking, interspersed by periods of 3 days at a time undertaking tests at Birmingham hospital. The third two weeks of drinking a liquid drug or placebo, that is the fifth and sixth weeks, were completely itch free so I assumed that I was on the drug then, but I don't know if that was actually the case.

I really enjoyed my time on the trial, meeting new people, getting to know the hospital in Birmingham in its very new buildings, the train journeys to get there and back, and would willingly be a participant in a trial in the future, if I was asked.

[mollymom]

Yes its the same med here....OCA

[Pat_H]

In that case I hope Britain does the same as the US and it is approved soon in the UK. I had two totally itch-free weeks - it was fantastic.