Intercept are asking for Pbc sufferers to take part in a trial

[Twinkle26]

I just saw this on Facebook and wondered if anyone else have come across it?

[Becca75]

how do we get in touch with them - I don't know what Intercept is

[Twinkle26 in reply to Becca75]

Www.pbc-study.com

[PBCFoundation PBC Foundation in reply to Becca75]

Intercept are a pharmaceutical company who are looking for people to sign up for a trial.

If you have registered with The PBC Foundation ( which is completley free to do so), there is information regarding the trials in The Bear Facts.

Best wishes

PBC Foundation

[Chazzy]

Oh can't see anything

[Twinkle26 in reply to Chazzy]

Www.pbc-study.com

[CathieG]

Just applied to Aidensbrook to join their trial.

[2bear]

Hi. Don't see anything Can u send what they wrote ? Thank.

[Twinkle26 in reply to 2bear]

Here's what I copied.

Intercept Pharmaceuticals is conducting a Phase III research study designed to study the effect of the investigational drug obeticholic acid (also known as OCA or INT-747) on the overall health and quality of life of patients with primary biliary cirrhosis, also called Primary Biliary Cholangitis and PBC.

PBC is a chronic autoimmune disease of the liver marked by the slow progressive destruction of the small bile ducts within the liver which may lead to liver failure and the need for liver transplantation. It is estimated that there are up to 300,000 patients with PBC worldwide.

The investigational drug, OCA, is a modified (man-made) version of a compound in the liver called a bile acid. Bile acids are used by the body to help with digestion. It is hoped that OCA will improve the health and quality of life in persons with PBC.

In this research study, eligible PBC participants will be assigned to receive the investigational drug OCA or placebo. The study treatment will be assigned randomly (like flipping a coin) with half the patients assigned to OCA and the other half to placebo. Neither the patient nor the doctor will know what study treatment has been assigned. Both OCA and Placebo will be given as a pill(s) to be taken once a day.

During this study, all patients will continue to be treated with the established standard treatment for their area, including ursodeoxycholic acid (also known as UDCA or URSO®). Patients will remain on study and continue to receive OCA or placebo along with standard treatment until the study is completed. It is estimated that patients will participate for a minimum of approximately 6 years. During this time, patients will be evaluated by the study team once every three months.

You may be eligible to participate if you have been diagnosed with Primary Biliary Cirrhosis (PBC) and have been taking UDCA for at least 12 months or are unable to tolerate UDCA and stopped taking it at least three months ago. For more details about this PBC study, including a list of requirements to enter the study, visit clinicaltrials.gov. This study has the clinical trials identifier: NCT02308111

A total of about 350 people are being recruited to participate in this study worldwide. To locate your nearest study center, please use our site locator. The study team will meet with you to discuss the study, review your medical and PBC history and perform screening tests to determine if you are eligible to participate.

I typed in pbc-study.com

[happyh13]

Hi folks,

I have been in the double blind OBC trial which started about 3 years ago worldwide. i was the last person to squeeze in the door in Australia. I believe it has helped a lot of people. I have not seem great reductions in my liver functions though My specialist says i have stabilised ALT and GGT though. It has not been easy for me - my itching increased and I had to reduce my medication down to 5mg per day. Some can tolerate 20mg, even 10 would be great but it sends me crazy with unbearable itch.

There are questionnaires you fill out every three months. I feel like I am well cared for and monitored by the hospital. The trial nurse is great. I havent grown any green horns or other weird side effects. So maybe this is doing nothing or delaying a transplant me.

For those who may have read my earlier posts my diagnosis was in 1994 when my ALP was 670! Then they thougt I'd have a transplant in 2 years. I could write a book on my story like many of you.. still here and am not on the transplant list!

Bottom line - research the research on OBC, go with your gut instinct to decide if it is right for you.

[susanburgess]

I had this 8 weeks ago i don’t seem to have any problems so they wanted some bloods to try to find out why I get no symptom to pbc I had this done at addenbrooks cambridge

[gwillistexas in reply to susanburgess]

So, they’re wanting to find out why you have no symptoms? Interesting. I’ve never had symptoms and I thought it was just understood that some do, some don’t. I’ve been on OCA 3 years.