Study for the new med Obetichiolic Acid and... - PBC Foundation

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Study for the new med Obetichiolic Acid and my experience

kauthement profile image
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Good Morning,

Here's a study for the new med Obetichiolic Acid and my experience for on applying;

Subject: NCT02308111, 747-302, Phase 3 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cirrhosis

(this is out of Nashville, TN, however I think they have other locations as well.)

This was the beginning conversation with the director of the clinical research.

Question:  Can you tell me what you total bilirubin is, also are you willing to travel to Nashville for your visits?

Answer:

ANTI-MITOCHONDRIAL ANTIBODY

55.9

ALBUMIN

4.2 g/dl

ALKALINE PHOSPHATASE 128 U/L

DIRECT BILIRUBIN 0.1 mg/dL

SGOT (AST) 16 U/L

SGPT (ALT) 17 U/L

TOTAL BILIRUBIN 0.3 mg/dL

TOTAL PROTEIN

7.4

Conclusion: This study is for people with advanced PBC. Your Alkaline Phosphatase has to be elevated to 500 or total bilirubin must be greater than the upper limit of normal. Your values are very good. You would not be eligible for this trial but keep in touch. We you having symptoms of PBC. Lots of patients do not take medications. If you are not having symptoms URSO is optional. There are usually assistance programs from the Drug Company. Have you tried to go that route?

My answer back: No Maam I haven't. My GI is insisting that I go on Urso, guess I'm confused as to whether I actually need it or not. Glad to hear I'm not advanced enough for testing. Will be going for second opinion. Maybe it seems I don't need to take it as of yet then.

Thank you for your help,

At least it may me feel good to hear that the numbers aren't bad, was told by doctor over the phone of dx and told to look it up, if I have any questions, ask. I can understand is that I had positive AMA's 55.9 and elevated ALP. I've looked back on previous blood tests and without taking the Urso, they have declined. So I'm confused as to if I need the drug as of yet. Anyway, second opinion appt. already set for July.

I posted to maybe help anyone that may fall into the category the study listed above.

Keep you posted.

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butterflyEi profile image
butterflyEi

Hello Kauthement

Thank you for your interesting post.  We really do get to hear so many different opinions from the professionals.  I hope your second opinion specialist can give you a more definitive answer.

best wishes

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