Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis
Primary Purpose
Primary Biliary Cirrhosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Obeticholic Acid
Sponsored by
About this trial
This is an interventional basic science trial for Primary Biliary Cirrhosis
Eligibility Criteria
Key Inclusion Criteria:
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 Criteria:
- 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.
Sites / Locations
- Scripps Clinic
- University of California, Davis Medical Center
- University of Miami
- Indiana University Medical Center
- Beth Israel Medical Center
- McGuire DVAMC
- Swedish Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OCA: 10 mg
Arm Description
Obeticholic acid, oral administration, 10 milligrams (mg), 8 weeks
Outcomes
Primary Outcome Measures
Absolute Change From Baseline In High-density Lipoprotein (HDL) Cholesterol Concentration
Absolute Change From Baseline In HDL Particle Size
Absolute Change From Baseline In HDL Particle Number
Secondary Outcome Measures
Median Change From Baseline In HDL Cholesterol Concentration At Weeks 4, 8, and 12
Median Change From Baseline In HDL Particle Size At Weeks 4, 8, and 12
Median Change From Baseline In HDL Particle Number At Weeks 4, 8, and 12
Median Change From Week 8 In HDL Cholesterol Concentration At Week 12
Median Change From Week 8 In HDL Particle Size At Week 12
Median Change From Week 8 In HDL Particle Number At Week 12
Maximum Plasma Concentration (Cmax) Of OCA And Conjugates
Results are reported in nanograms per milliliter (ng/mL).
Time To Reach Cmax (Tmax) For OCA And Conjugates
Results are reported in hours (h).
Area Under The Concentration-time Curve From Hour 0 To Last Sampling Time (Hour 6) (AUC0-6) For OCA And Conjugates
Results are reported in hour*nanograms per milliliter (h*ng/mL).
Median Change From Baseline In Total Cholesterol
Median Change From Baseline In Total Triglycerides
Median Change From Baseline In Low-density Lipoprotein (LDL) Cholesterol (Direct)
Median Change From Baseline In LDL Particle Size
Median Change From Baseline In Total LDL Particles
Results are reported in nanomoles per liter (nmol/L).
Median Change From Baseline In Very Low-density Lipoprotein (VLDL) Cholesterol
Results are reported in milligrams per deciliter (mg/dL).
Median Change From Baseline In VLDL Particle Size
Median Change From Baseline In VLDL Particles
Median Change From Baseline In Apolipoprotein A1 (ApoA1)
Results are reported in grams per liter (g/L).
Median Change From Baseline In Apolipoprotein B (ApoB)
Median Change From Baseline In ApoA1/ApoB Ratio
Median Change From Baseline In Apolipoprotein E
Median Change From Baseline In Lipoprotein-a
Median Change From Baseline In Lecithin-cholesterol Acyltransferase Activity
Results are reported in nanomoles/milliliter/hour (nmol/mL/h).
Median Change From Baseline In Cholesteryl Ester Transfer Protein
Results are reported in picomole/milliliter/minute (pmol/mL/min).
Median Change From Baseline In Prebeta-1 HDL Concentration
Results are reported in microgram/milliliter (ug/mL).
Median Change From Baseline In Macrophage Cholesterol Efflux
Results are reported as a percentage of cholesterol.
Median Change From Baseline In C-reactive Protein
Median Change From Baseline In Glycoprotein A
Results are reported in picograms/milliliter (pg/mL).
Median Change From Baseline In Fibroblast Growth Factor-19
Participants With Lipoprotein X
Lipoprotein samples were assessed using nuclear magnetic resonance spectroscopy for the presence/absence of Lipoprotein X. Lipoprotein X sometimes appears with advanced cholestasis and can confound assessment of other lipoprotein concentrations, particularly LDL.
Median Change From Baseline In Alkaline Phosphatase
Results are reported in units/Liter (U/L).
Median Change From Baseline In Gamma-glutamyl Transferase
Median Change From Baseline In Alanine Aminotransferase
Median Change From Baseline In Aspartate Aminotransferase
Median Change From Baseline In Total And Unconjugated (Direct) Bilirubin
Median Change From Baseline In Albumin
Median Change From Baseline In Prothrombin Time
Results are reported in seconds (sec).
Median Change From Baseline In Prothrombin International Normalized Ratio
Median Change From Baseline In Enhanced Liver Fibrosis (ELF) Score
Change in ELF was calculated as ELF score at the end of the study minus ELF score prior to the intervention (at baseline). A decrease in the ELF score was considered good as it reflected a decrease in liver fibrosis, and an increase in ELF score was considered bad as it reflected an increase in liver fibrosis.
Change in ELF scores ranged from -0.56 (good) to + 0.68 (bad).
Median Change From Baseline In Hyaluronic Acid
Median Change From Baseline In Amino-terminal Propeptide Of Type III Procollagen
Results are reported in micrograms/Liter (ug/L).
Median Change From Baseline In Tissue Inhibitor Of Metalloproteinases 1
Median Change From Baseline In Hepatic Stiffness
Results are reported in kilopascal (kPa).
Median Change From Baseline In Total Bile Acids
Median Change From Baseline In Total Endogenous Bile Acid
Median Change From Baseline In Total UDCA
Median Change From Baseline In Total Chenodeoxycholic Acid
Median Change From Baseline In Total Lithocholic Acid
Median Change From Baseline In Total Cholic Acid
Median Change From Baseline In Total Deoxycholic Acid
Absolute Change From Baseline In HDL Cholesterol Concentration
Absolute Change From Baseline In HDL Particle Size
Absolute Change From Baseline In HDL Particle Number
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01865812
Brief Title
Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis
Official Title
A Phase 2 Clinical Trial Investigating the Effects of Obeticholic Acid on Lipoprotein Metabolism in Subjects With Primary Biliary Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 3, 2013 (Actual)
Primary Completion Date
August 13, 2014 (Actual)
Study Completion Date
September 12, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intercept Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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. Nuclear magnetic resonance spectroscopy was utilized to quantify the changes in lipoprotein particle sizes and concentrations. Components of reverse cholesterol transport were also assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cirrhosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OCA: 10 mg
Arm Type
Experimental
Arm Description
Obeticholic acid, oral administration, 10 milligrams (mg), 8 weeks
Intervention Type
Drug
Intervention Name(s)
Obeticholic Acid
Other Intervention Name(s)
6α-Ethyl chenodeoxycholic acid (6-ECDCA), INT-747
Intervention Description
All participants were treated with OCA (oral administration, 10 mg, once daily [QD]) for 8 weeks and continued their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8-week Primary Treatment Phase of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter an open-label, long-term safety extension phase, during which they could receive 10 mg OCA QD for up to 2 years.
Primary Outcome Measure Information:
Title
Absolute Change From Baseline In High-density Lipoprotein (HDL) Cholesterol Concentration
Time Frame
Baseline, Week 8
Title
Absolute Change From Baseline In HDL Particle Size
Time Frame
Baseline, Week 8
Title
Absolute Change From Baseline In HDL Particle Number
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Median Change From Baseline In HDL Cholesterol Concentration At Weeks 4, 8, and 12
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Median Change From Baseline In HDL Particle Size At Weeks 4, 8, and 12
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Median Change From Baseline In HDL Particle Number At Weeks 4, 8, and 12
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Median Change From Week 8 In HDL Cholesterol Concentration At Week 12
Time Frame
Week 8, Week 12
Title
Median Change From Week 8 In HDL Particle Size At Week 12
Time Frame
Week 8, Week 12
Title
Median Change From Week 8 In HDL Particle Number At Week 12
Time Frame
Week 8, Week 12
Title
Maximum Plasma Concentration (Cmax) Of OCA And Conjugates
Description
Results are reported in nanograms per milliliter (ng/mL).
Time Frame
Week 8
Title
Time To Reach Cmax (Tmax) For OCA And Conjugates
Description
Results are reported in hours (h).
Time Frame
Week 8
Title
Area Under The Concentration-time Curve From Hour 0 To Last Sampling Time (Hour 6) (AUC0-6) For OCA And Conjugates
Description
Results are reported in hour*nanograms per milliliter (h*ng/mL).
Time Frame
Week 8
Title
Median Change From Baseline In Total Cholesterol
Time Frame
Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose
Title
Median Change From Baseline In Total Triglycerides
Time Frame
Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose
Title
Median Change From Baseline In Low-density Lipoprotein (LDL) Cholesterol (Direct)
Time Frame
Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose
Title
Median Change From Baseline In LDL Particle Size
Time Frame
Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose
Title
Median Change From Baseline In Total LDL Particles
Description
Results are reported in nanomoles per liter (nmol/L).
Time Frame
Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose
Title
Median Change From Baseline In Very Low-density Lipoprotein (VLDL) Cholesterol
Description
Results are reported in milligrams per deciliter (mg/dL).
Time Frame
Baseline, Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose
Title
Median Change From Baseline In VLDL Particle Size
Time Frame
Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose
Title
Median Change From Baseline In VLDL Particles
Time Frame
Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose
Title
Median Change From Baseline In Apolipoprotein A1 (ApoA1)
Description
Results are reported in grams per liter (g/L).
Time Frame
Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose
Title
Median Change From Baseline In Apolipoprotein B (ApoB)
Time Frame
Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose
Title
Median Change From Baseline In ApoA1/ApoB Ratio
Time Frame
Baseline, Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose
Title
Median Change From Baseline In Apolipoprotein E
Time Frame
Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose
Title
Median Change From Baseline In Lipoprotein-a
Time Frame
Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose
Title
Median Change From Baseline In Lecithin-cholesterol Acyltransferase Activity
Description
Results are reported in nanomoles/milliliter/hour (nmol/mL/h).
Time Frame
Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT
Title
Median Change From Baseline In Cholesteryl Ester Transfer Protein
Description
Results are reported in picomole/milliliter/minute (pmol/mL/min).
Time Frame
Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT
Title
Median Change From Baseline In Prebeta-1 HDL Concentration
Description
Results are reported in microgram/milliliter (ug/mL).
Time Frame
Baseline, Week 4, Week 8/End of Treatment (EOT), Month 6, Month 12, Month 18, Month 24/EOT
Title
Median Change From Baseline In Macrophage Cholesterol Efflux
Description
Results are reported as a percentage of cholesterol.
Time Frame
Baseline, Week 4, Week 8/End of Treatment (EOT), Month 6, Month 12, Month 18, Month 24/EOT
Title
Median Change From Baseline In C-reactive Protein
Time Frame
Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT
Title
Median Change From Baseline In Glycoprotein A
Description
Results are reported in picograms/milliliter (pg/mL).
Time Frame
Baseline, Week 12, Month 6, Month 12, Month 18, Month 24/EOT
Title
Median Change From Baseline In Fibroblast Growth Factor-19
Time Frame
Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT
Title
Participants With Lipoprotein X
Description
Lipoprotein samples were assessed using nuclear magnetic resonance spectroscopy for the presence/absence of Lipoprotein X. Lipoprotein X sometimes appears with advanced cholestasis and can confound assessment of other lipoprotein concentrations, particularly LDL.
Time Frame
Week 12 and Last Dose
Title
Median Change From Baseline In Alkaline Phosphatase
Description
Results are reported in units/Liter (U/L).
Time Frame
Baseline, Month 6, Month 12, Month 18, Month 24/EOT
Title
Median Change From Baseline In Gamma-glutamyl Transferase
Time Frame
Baseline, Month 6, Month 12, Month 18, Month 24/EOT
Title
Median Change From Baseline In Alanine Aminotransferase
Time Frame
Baseline, Month 6, Month 12, Month 18, Month 24/EOT
Title
Median Change From Baseline In Aspartate Aminotransferase
Time Frame
Baseline, Month 6, Month 12, Month 18, Month 24/EOT
Title
Median Change From Baseline In Total And Unconjugated (Direct) Bilirubin
Time Frame
Baseline, Month 6, Month 12, Month 18, Month 24/EOT
Title
Median Change From Baseline In Albumin
Time Frame
Baseline, Month 6, Month 12, Month 18, Month 24/EOT
Title
Median Change From Baseline In Prothrombin Time
Description
Results are reported in seconds (sec).
Time Frame
Baseline, Month 6, Month 12, Month 18, Month 24/EOT
Title
Median Change From Baseline In Prothrombin International Normalized Ratio
Time Frame
Baseline, Month 6, Month 12, Month 18, Month 24/EOT
Title
Median Change From Baseline In Enhanced Liver Fibrosis (ELF) Score
Description
Change in ELF was calculated as ELF score at the end of the study minus ELF score prior to the intervention (at baseline). A decrease in the ELF score was considered good as it reflected a decrease in liver fibrosis, and an increase in ELF score was considered bad as it reflected an increase in liver fibrosis.
Change in ELF scores ranged from -0.56 (good) to + 0.68 (bad).
Time Frame
Baseline, Month 12, Month 24/EOT
Title
Median Change From Baseline In Hyaluronic Acid
Time Frame
Baseline, Month 12, Month 24/EOT
Title
Median Change From Baseline In Amino-terminal Propeptide Of Type III Procollagen
Description
Results are reported in micrograms/Liter (ug/L).
Time Frame
Baseline, Month 12, Month 24/EOT
Title
Median Change From Baseline In Tissue Inhibitor Of Metalloproteinases 1
Time Frame
Baseline, Month 12, Month 24/EOT
Title
Median Change From Baseline In Hepatic Stiffness
Description
Results are reported in kilopascal (kPa).
Time Frame
Baseline, Month 12, Month 24/EOT
Title
Median Change From Baseline In Total Bile Acids
Time Frame
Baseline, Month 6, Month 12, Month 18, Month 24/EOT
Title
Median Change From Baseline In Total Endogenous Bile Acid
Time Frame
Baseline, Month 6, Month 12, Month 18, Month 24/EOT
Title
Median Change From Baseline In Total UDCA
Time Frame
Baseline, Month 6, Month 12, Month 18, Month 24/EOT
Title
Median Change From Baseline In Total Chenodeoxycholic Acid
Time Frame
Baseline, Month 6, Month 12, Month 18, Month 24/EOT
Title
Median Change From Baseline In Total Lithocholic Acid
Time Frame
Baseline, Month 6, Month 12, Month 18, Month 24/EOT
Title
Median Change From Baseline In Total Cholic Acid
Time Frame
Baseline, Month 6, Month 12, Month 18, Month 24/EOT
Title
Median Change From Baseline In Total Deoxycholic Acid
Time Frame
Baseline, Month 6, Month 12, Month 18, Month 24/EOT
Title
Absolute Change From Baseline In HDL Cholesterol Concentration
Time Frame
Baseline, Month 24/EOT
Title
Absolute Change From Baseline In HDL Particle Size
Time Frame
Baseline, Month 24/EOT
Title
Absolute Change From Baseline In HDL Particle Number
Time Frame
Baseline, Month 24/EOT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Harb, MD
Organizational Affiliation
Intercept Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
McGuire DVAMC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis
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