So I have been going through testing the last two weeks to see if I can qualify for a clinical trial. I have cirrhosis that was just diagnosed in February. It will be a couple of weeks before I know for sure but so far things look good.
My question is , for those who have participated in clinical trials in the past, what kind of diary did you use while you were in the trial was it a paper diary or did you use an electronic one?
Thanks in advance to all who can answer.
Wendy
I didn't use any. I saw the research person once a month. I had forms to fill out every time. Exhaustion was the biggest. Been on it 9 months now, 9 to go. My Dr is sure I have the right bill as my fiber scan went from, 17.8 to 11.4. Worst part was the biopsy. One more to go.
I had one liver Biopsy in January and one last week to get in to the study. I think there might be one or two more while I am taking the study drug. Do you think the exhaustion that you are experiencing is a side effect of the cirrhosis or a side effect of the meds that you are on?
I was diagnosed in February and I am still working. I have been teleworking since March and I want to try to keep working as long as I can.
I was diagnosed 20 years ago In stage 3 to4 fibrosis. I've never stopped working. It is a side affect of the drug. The paperwork ask you the question every month . Its different from the cirrhosis exhaustion. I have missed very little work over the years. Keep on going and dont look back. It's kept me alive this long
Thank you so much for sharing your experiences. This is all very new to me. If the final tests come in the way they are thinking they will, I should start the study drug on Or about November 6th.
I am going to try and follow your advice and keep on going and not look back.
Bless you .
Hi, I'm new to the forum, have cirrhosis and have since I was six and I'm twenty now, how do you go about clinical trials or is it just for newly diagnosed patients? Also, what's the clinical trial for if you don't mind me asking what drug it's for? I'm curious to research Cirrhosis more as I get older.
Hi,
I’m in my 2nd clinical trial and I didn’t specifically keep a diary at all, but I bought a large 3 ring binder to keep all records in. I have various sections in the binder: a section for monthly blood test results, a section for liver biopsy results, (I’ve had 3 biopsies so far) a section for any imaging such as the MRI series I’ve had every 3 months, a section for Fibroscan results, I keep a copy of the clinical trial consent form document which includes a checklist of what will occur at each monthly visit. If there’s anything additional that I need to document, I put those notes in a section. Sometimes I type the notes and print them out for the binder. This is just a basic idea of how I handle my clinical trial information.
I was approved for the 1st trial I applied for in June 2018, and that one lasted a year. Last summer I applied for another and was not selected, and then October 16, 2020 I was approved for the current trial I’m participating in.
I hope that you’re approved for the trial by now since you posted 4 months ago. I hadn’t signed on to this site recently so hadn’t seen your post earlier.
Good luck
Thank you for your response. I did get selected for the trial and started taking the trial meds in early November. I have to take two trial meds, one is a statin drug and the other one is an injectable. I was giving 2 wire bound books to record when I took the meds. I also have a binder similar to what you described.
No side effects except occasionally diarrhea. It is just a small amount and doesn’t cause too many problems at this time. This trial is about a year.
Thank you for responding. I hope you are doing well in your clinical trial.
Hi!
I’m glad to hear that you did get selected for the trial! I take 3 pills each morning & record date & time next to the pills that come in a weekly card. Each month I get 4 cards. Of course I don’t know if I’m on the drug or a placebo. There are 2 doses of the drug & 1 placebo so I had 2 out of 3 chances to be on the drug. I’m already on a statin anyway prior to starting the trial in October. Mine is a year long also.
Happy to hear it is going well for you and hopefully that continues. My liver clinic participates in many clinical trials so I’m fortunate to have that option available. I initially was to continue for a 2nd year on the 1st trial I participated in, (a phase 2 trial) but that trial was halted just as phase 3 was to begin. I applied for another trial several months later but was not approved for that one.
So far I haven’t had any symptoms that I didn’t already experience at times.
I had an MRI series done for the trial yesterday & have my monthly appointment at the clinic this morning. I would continue having my on going care at the clinic even if I didn’t participate in a trial, but the trials are important in finding a medication that can help NASH and Cirrhosis and there’s always that chance that we get to try the actual medication that hopefully improves our condition!
what phase is your trial in? Mine is phase 3.
My trial is considered 2B and it is suppose to last about a year. I have no idea if I am on the drug or on the placebo. I take a shot once a day, and then take the statin. Right now I am going to the clinic for follow up about every six weeks. It is a bit of a drive, about 3 hours from home.
Everybody I have met associated with the trial, have been wonderful. They delivered medication to my house today. I pick up the injectable medication at the hospital when I go for follow up.
I wanted to apply for a clinical trial that required daily injections but I think that’s the one that had an age limit and I had just aged out the month before! I hope you’re on the actual drug. Like you, I don’t know if I’m on the drug or the placebo.
All the staff at my liver clinic are very pleasant to deal with too. I go in once a month. I don’t have as long a drive as you do. It’s about 15 miles from my house which is convenient. I actually made that drive for 22 years prior to retiring as the clinic is close to where I used to work.
I like participating in clinical trials as we are monitored closer than we otherwise would be. And though I don’t get results of trial related MRIs, I do get copies of the monthly blood test results.
Have you gotten a Covid vaccination? I got the 1st one yesterday morning. My arm got really sore by last night, but I haven’t had any other side effects. I’ve had a sore arm after the pneumonia vaccine, shingles vaccines, sometimes the flu vaccine though so I expected it with the Covid one too.
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