Status:
COMPLETED
Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis
Lead Sponsor:
Intercept Pharmaceuticals
Conditions:
Primary Biliary Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study was to determine if OCA had an effect on cholesterol levels in the blood in participants with primary biliary cirrhosis (PBC).
Detailed Description
This was a phase 2, open-label, multicenter study evaluating the effects of OCA on lipoprotein metabolism in participants with PBC; in particular, OCA's effects on high-density lipoprotein cholesterol...
Eligibility Criteria
Inclusion
- Key
- Definite or probable PBC diagnosis as demonstrated by the presence of ≥ 2 of the following 3 diagnostic factors:
- History of elevated alkaline phosphatase levels for at least 6 months
- A positive anti-microbial antibody (AMA) titer or, if AMA negative or in low titer (\<1:80), PBC-specific antibodies
- Liver biopsy consistent with PBC
- Taking UDCA for at least 12 months (stable dose for ≥ 3 months) prior to Day 0 or unable to tolerate UDCA (no UDCA for ≥ 3 months prior to Day 0).
- Contraception: Female participants must have been postmenopausal, surgically sterile, or if premenopausal, were prepared to use ≥ 1 effective (≤ 1% failure rate) method of contraception during the trial and until at least 30 days after the last dose of Investigational Product.
- Must have provided written informed consent and agreed to comply with the trial protocol.
- Key
Exclusion
- Participants with decompensated PBC (as determined by the Investigator).
- Severe pruritus or systemic treatment for pruritus (for example, treatment with bile acid sequestrants or rifampicin) within 2 months of Day 0.
- History or presence of other significant liver diseases including:
- Active or chronic Hepatitis B or C virus infection
- Primary sclerosing cholangitis
- Alcoholic liver disease
- Definite autoimmune liver disease or overlap hepatitis
- Nonalcoholic steatohepatitis
- Note: Participants with Gilbert's disease or those with a history of hepatitis B who were currently antigen negative and seroconverted were not considered exclusionary.
- Uncontrolled diabetes or other uncontrolled or unstable medical condition that may have interfered with trial results.
- Administration of any of the following medications as specified below:
- Prohibited 28 days prior to Day 0: bile acid sequestrants including cholestyramine, colesevelam, colestipol or omega-3 fatty acid containing dietary supplements
- Prohibited 3 months prior to Day 0 and throughout trial participation: serum-lipid modifying agents including 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors, fenofibrate or other fibrates, nicotinic acid and derivatives, ezetimibe, Vitamin E (other than as standard dietary supplement)
- Prohibited 6 months prior to Day 0 and throughout the trial participation: azathioprine, colchicine, cyclosporine, methotrexate, mycophenolate mofetil, pentoxifylline; budesonide and other systemic corticosteroids; potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazide, or nitrofurantoin)
- Prohibited 12 months prior to Day 0 and throughout the trial participation: antibodies or immunotherapy directed against interleukins or other cytokines or chemokines
- Planned change in diet or exercise habits during participation in the trial.
- Presence or history of clinically significant cardiac arrhythmias that may have prohibited the participant from participating in the trial.
- If female: known pregnancy, or had a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.
- Recent (3 months prior to day 0) participation in another trial involving OCA or participation in another investigational trial (30 days prior to Day 0) and during the trial.
Key Trial Info
Start Date :
December 3 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2016
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01865812
Start Date
December 3 2013
End Date
September 12 2016
Last Update
August 24 2022
Active Locations (7)
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1
Scripps Clinic
La Jolla, California, United States, 92037
2
University of California, Davis Medical Center
Sacramento, California, United States, 95817
3
University of Miami
Miami, Florida, United States, 33136
4
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202