Progress depends on YOU!
The FDA approval of obeticholic acid (OCA, trade name Ocaliva) for the treatment of PBC represents the first advance since the approval of ursodeoxycholic acid in 1997.
However, several important issues need more study. Your voluntary participation in current and upcoming clinical trials for PBC is crucial for researchers to accelerate progress toward therapies that will benefit each and every individual.
Here is a list of currently enrolling and upcoming trials:
1. Intercept OCA (modified bile acid FXR agonist) vs placebo in persons with advanced disease to prove that OCA treatment benefits patient outcomes
2. Intercept OCA (modified bile acid FXR agonist) for patients with significant hepatic impairment due to advanced cirrhosis to determine safe dosing and effectiveness
3. Gilead GS-9674, a non-bile acid FXR agonist, for patients with PBC who do not have cirrhosis.
4. Novartis LJN452A, a non-bile acid FXR agonist being considered for patients with PBC.
5. NGM Biopharmaceuticals NGM282, a modified FGF-19 inhibitor of bile acid synthesis for patients with PBC.
For a list of participating research sites near you, go to Clinical Trials
If you live in the South Texas, please call Baylor College of Medicine at 832 355 7608.
Current Clinical Trials:
Below are current PBC Studies listed on the U.S. National Institutes of Health site
These trials are in the US and other countries. Location is listed under trial name.
Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis (PBC)
Location: Univeristy of California Davis Medical Center in Sacramento
Interrogating Potential Therapeutic Targets for Primary Biliary Cirrhosis (PBC)
Location: Univeristy of California Davis Medical Center in Sacramento
A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of LJN452 in PBC Patients
Location: CA, FL, GA, KY, NY, TX & WA, Germany & UK
Evaluation of Patients With Liver Disease
Location: Maryland
Pilot Study of FFP104 Dose Escalation in PBC Subjects
Location: Netherlands & UK
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
Location: China
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Location: China
Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary Cirrhosis
Location: Poland
Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary Cholangitis
Location: Japan
IBAT Inhibitor A4250 for Cholestatic Pruritus
Location: Sweden
The Health Burden of Primary Biliary Cirrhosis (PBC)
Location: Switzerland