Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
Status: | Recruiting |
---|---|
Conditions: | Gastrointestinal, Gastrointestinal, Hepatitis |
Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/21/2019 |
Start Date: | August 30, 2017 |
End Date: | July 2021 |
Contact: | Roger Davies |
Email: | roger.davies@interceptpharma.com |
Phone: | 1-619-541-7249 |
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747)
can lead to histological improvement in fibrosis with no worsening of NASH in adults with
compensated cirrhosis due to NASH.
can lead to histological improvement in fibrosis with no worsening of NASH in adults with
compensated cirrhosis due to NASH.
Key inclusion criteria:
1. Subjects with a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the
NASH CRN scoring system determined by central reading
Key exclusion criteria:
1. Current or past history of hepatic decompensation such as clinically significant
ascites, hepatic encephalopathy (HE), or variceal bleeding
2. Current or past history of CP score ≥7 points
3. Model for End-stage Liver Disease (MELD) score > 12
4. ALT ≥ 5 X ULN
5. Calculated creatinine clearance <60mL/min using Cockcroft-Gault method
6. Hemoglobin A1c ≥ 9.5 %
7. Evidence of other known forms of chronic liver disease such as alcoholic liver
disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease,
iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or
suspected hepatocellular carcinoma (HCC)
8. History of liver transplant, or current placement on a liver transplant list
We found this trial at
176
sites
Rocky Mount, North Carolina 27804
Principal Investigator: Mitchell Mah'moud, MD
Phone: 252-937-0484
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185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
![Massachusetts General Hospital](/wp-content/uploads/logos/mgh_hms.gif)
Principal Investigator: Kathleen Corey, MD
Phone: 617-724-3836
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330 Brookline Ave
Boston, Massachusetts 02215
Boston, Massachusetts 02215
617-667-7000
![Beth Israel Deaconess Medical Center](/wp-content/uploads/logos/beth-israel-deaconess-medical-center.jpg)
Principal Investigator: Michelle Lai, MD
Phone: 617-632-1129
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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3550 Jerome Avenue
Bronx, New York 10467
Bronx, New York 10467
(718) 920-4321
![Montefiore Medical Center](/wp-content/uploads/logos/montefiore-medical-center.gif)
Principal Investigator: Samuel Sigal, MD
Phone: 718-920-4354
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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2500 N State St
Jackson, Mississippi 39216
Jackson, Mississippi 39216
(601) 984-1000
![University of Mississippi Medical Center](/wp-content/uploads/logos/university-of-mississippi-medical-center.png)
Principal Investigator: Thomas Amankonah, MD
Phone: 601-815-5180
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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529 West Markham Street
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
(501) 686-7000
![University of Arkansas for Medical Sciences](/wp-content/uploads/logos/university-of-arkansas-for-medical-sciences.jpg)
Principal Investigator: Jonathan Dranoff, MD
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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610 3rd St # 206
Macon, Georgia 31201
Macon, Georgia 31201
Principal Investigator: Shahriar Sedghi, MD
Phone: 478-464-2600
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3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
![Hospital of the University of Pennsylvania](/wp-content/uploads/logos/hospital-of-the-university-of-pennsylvania.gif)
Principal Investigator: K. Reddy, MD
Phone: 215-349-8563
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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601 Elmwood Avenue
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2100
![Univ of Rochester Medical Center](/wp-content/uploads/logos/univ-of-rochester-medical-center.jpg)
Principal Investigator: Jonathan Huang, DO
Phone: 585-276-3042
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
San Antonio, Texas 78229
210-949-0122
![Clinical Trials of Texas, Inc.](/wp-content/uploads/logos/ctotexas.gif)
Principal Investigator: Douglas Denham, DO, CPI
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500 S State St
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 764-1817
![University of Michigan](/wp-content/uploads/logos/university-of-michigan.jpg)
Principal Investigator: Hari Conjeevaram, MD
Phone: 734-764-4048
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Arlington, Texas 76012
Principal Investigator: Reem Ghalib, MD
Phone: 817-471-1070
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Asheville, North Carolina 28801
Principal Investigator: Adam Zivony, MD
Phone: 828-254-0881
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Athens, Georgia 30607
Principal Investigator: Jeffrey Williams, MD
Phone: 706-400-4262
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Atlanta, Georgia 30322
Principal Investigator: Ryan Ford, MD
Phone: 404-712-1737
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Aurora, Colorado 80045
Principal Investigator: Amanda Wieland, MD
Phone: 303-724-1871
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Aventura, Florida 33180
Principal Investigator: Isaac Bassan, MD
Phone: 305-759-1881
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345 St Paul Pl
Baltimore, Maryland 21202
Baltimore, Maryland 21202
(410) 332-9000
![Mercy Medical Center](/wp-content/uploads/logos/mercy-medical-center.jpg)
Principal Investigator: Paul Thuluvath, MD
Phone: 410-843-2069
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Baltimore, Maryland 21201
Principal Investigator: Jennifer Husson, MD, MPH
Phone: 410-706-2564
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Beavercreek, Ohio 45440
Principal Investigator: Rupa Fritz, MD
Phone: 937-320-5050
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8901 Rockville Pike
Bethesda, Maryland 20889
Bethesda, Maryland 20889
(301) 295-4000
![Walter Reed National Military Medical Center](/wp-content/uploads/logos/walter-reed-national-military-medical-center.jpg)
Principal Investigator: Dawn Torres, MD
Phone: 301-319-8713
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Bethlehem, Pennsylvania 18017
Principal Investigator: Adam Peyton, DO
Phone: 610-433-4100
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Birmingham, Alabama 35294
Principal Investigator: Omar Massoud, MD
Phone: 205-934-7332
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Buffalo, New York 14203
Principal Investigator: Andrew Talal, MD
Phone: 716-878-3320
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Burlington, Massachusetts 01805
Principal Investigator: Frederic Gordon, MD
Phone: 781-744-3367
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Burlington, Vermont 05405
Principal Investigator: Steven Lidofsky, MD, PhD
Phone: 802-656-9957
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Canoga Park, California 91303
Principal Investigator: Hessam Aazami, MD
Phone: 818-999-4673
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1955 West Frye Road
Chandler, Arizona 85224
Chandler, Arizona 85224
Principal Investigator: Anita Kohli, MD
Phone: 480-767-4541
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Chapel Hill, North Carolina 27599
Principal Investigator: A. Barritt, IV, MD
Phone: 919-843-5732
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109 Bee Street
Charleston, South Carolina 29401
Charleston, South Carolina 29401
Principal Investigator: Wing-Kin Syn, MD
Phone: 843-789-7816
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Charleston, South Carolina 29425
Principal Investigator: Don Rockey, MD
Phone: 843-876-8439
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Charlotte, North Carolina 28207
Principal Investigator: Jason Wilson, MD
Phone: 704-602-6564
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Chicago, Illinois 60611
Principal Investigator: Mary Rinella, MD
Phone: 312-694-0326
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1653 W. Congress Parkway
Chicago, Illinois 60612
Chicago, Illinois 60612
(312) 942-5000
![Rush University Medical Center](/wp-content/uploads/logos/rush-university-medical-center.jpg)
Principal Investigator: Sujit Janardhan, MD
Phone: 312-942-3354
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chula Vista, California 91910
Principal Investigator: Cynthia Schaeffer, MD
Phone: 619-501-0371
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Cincinnati, Ohio 45219
Principal Investigator: Ravi Ravinuthala, MD
Phone: 513-587-0410
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Cincinnati, Ohio 45267
Principal Investigator: Kenneth Sherman, MD, PhD
Phone: 513-584-5245
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Colorado Springs, Colorado 80907
Principal Investigator: Bhaktasharan Patel, MD
Phone: 719-362-2270
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410 W 10th Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(614) 293-8652
![The Ohio State University, Wexner Medical Center](/wp-content/uploads/logos/the-ohio-state-university-wexner-medical-center.jpg)
Principal Investigator: Na Li, MD, PhD
Phone: 614-366-6199
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Coral Gables, Florida 33134
Principal Investigator: Jorge Beato, MD
Phone: 786-717-7515
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Cutler Bay, Florida 33189
Principal Investigator: Jose Ruiz, MD
Phone: 305-971-6883
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Dallas, Texas 75234
Principal Investigator: Abdullah Mubarak, MD
Phone: 469-317-7703
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Dallas, Texas 75231
Principal Investigator: James Trotter, MD
Phone: 817-310-4480
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Dallas, Texas 75203
Principal Investigator: Parvez Mantry, MD
Phone: 214-947-1280
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2201 Inwood Rd
Dallas, Texas 75235
Dallas, Texas 75235
(214) 645-8300
![U.T. Southwestern Medical Center](/wp-content/uploads/logos/u-t-southwestern-medical-center.jpg)
Principal Investigator: Carol Murakami, MD
Phone: 214-645-6188
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Doral, Florida 33166
Principal Investigator: Adolpho Cueli, MD
Phone: 305-552-7660
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Dothan, Alabama 36305
Principal Investigator: William McLaughlin, MD
Phone: 334-836-3341
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2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
![Duke Univ Med Ctr](/wp-content/uploads/logos/duke-univ-med-ctr.png)
Principal Investigator: Manal Abdelmalek, MD
Phone: 919-684-0816
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Englewood, Colorado 80113
Principal Investigator: Marcelo Kugelmas, MD
Phone: 303-406-4139
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1811 Bethlehem Pike
Flourtown, Pennsylvania 19031
Flourtown, Pennsylvania 19031
Principal Investigator: Victor Araya, MD
Phone: 215-402-0800
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Fort Sam Houston, Texas 78234
Principal Investigator: Angelo Paredes, MD
Phone: 210-916-2746
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1400 8th Avenue
Fort Worth, Texas 76104
Fort Worth, Texas 76104
Principal Investigator: Stevan Gonzalez, MD
Phone: 817-922-2572
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Fort Worth, Texas 76104
Principal Investigator: Apurva Modi, MD
Phone: 817-310-4478
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Fresno, California
Principal Investigator: Marina Roytman, MD
Phone: 559-499-6637
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Gulfport, Mississippi 39501
Principal Investigator: Navin Barot, MD
Phone: 512-717-8610
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Haines City, Florida 33844
Principal Investigator: Raphael Lopez, MD
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Hermitage, Tennessee
Principal Investigator: Kevin Finnegan, MD
Phone: 615-499-4740
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Hershey, Pennsylvania 17033
Principal Investigator: Karen Krok, MD
Phone: 717-531-5226
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6620 Main Street
Houston, Texas 77030
Houston, Texas 77030
Principal Investigator: John Vierling, MD
Phone: 713-798-5382
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Houston, Texas 77030
Principal Investigator: Maya Balakrishman, MD, MPH
Phone: 713-798-7542
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Houston, Texas 77030
Principal Investigator: Victor Ankoma-Sey, MD
Phone: 713-799-2667
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Houston, Texas 77030
Principal Investigator: Moises Nevah Rubin, MD
Phone: 713-500-6456
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Houston, Texas 77036
Principal Investigator: Alan Glombicki, MD
Phone: 281-324-0575
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6550 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 790-3311
![Houston Methodist Hospital](/wp-content/uploads/logos/houston-methodist-hospital.jpg)
Principal Investigator: David Victor, III, MD
Phone: 713-441-6316
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Houston, Texas 77089
Principal Investigator: Munir Loya, MD
Phone: 832-847-1727
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Huntersville, North Carolina 28078
Principal Investigator: Robert Reindollar, MD
Phone: 704-801-5203
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Huntersville, North Carolina 28078
Principal Investigator: Robert Reindollar, MD
Phone: 704-355-4875
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Idaho Falls, Idaho 83404
Principal Investigator: Larry Evans, DO
Phone: 208-428-5246
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Inverness, Florida 34452
Principal Investigator: Paul Hellstern, MD
Phone: 352-341-2100
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200 Hawkins Dr,
Iowa City, Iowa 52242
Iowa City, Iowa 52242
866-452-8507
![University of Iowa Hospitals and Clinics](/wp-content/uploads/logos/university-of-iowa-hospitals-and-clinics.jpg)
Principal Investigator: Huy Tran
Phone: 319-353-4575
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Jackson, Mississippi 39216
Principal Investigator: Brian Borg, MD
Phone: 769-251-5674
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Jackson, Tennessee 38305
Principal Investigator: Bob Souder, MD
Phone: 731-431-5027
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4555 Emerson Street
Jacksonville, Florida 32207
Jacksonville, Florida 32207
Principal Investigator: Miguel Malespin, MD
Phone: 904-633-0070
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Jacksonville, Florida 32256
Principal Investigator: Linda DiTeodoro, MD
Phone: 904-680-0871
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4500 San Pablo Rd S
Jacksonville, Florida 32224
Jacksonville, Florida 32224
(904) 953-2000
![Mayo Clinic Florida](/wp-content/uploads/logos/mayo-clinic-florida.jpg)
Principal Investigator: Maria Yataco, MD
Phone: 904-953-8503
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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Johnson City, Tennessee 37604
Principal Investigator: Chakradhar Reddy, MD
Phone: 423-434-3701
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Kansas City, Kansas 64128
Principal Investigator: Prashant Pandya, DO
Phone: 816-861-4700
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3901 Rainbow Blvd
Kansas City, Kansas 66160
Kansas City, Kansas 66160
(913) 588-5000
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Principal Investigator: Winston Dunn, MD
Phone: 913-588-3708
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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425 Volker Boulevard
Kansas City, Missouri 64131
Kansas City, Missouri 64131
Principal Investigator: Bradley Freilich, MD
Phone: 816-759-5274
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Kingswood, New South Wales
Principal Investigator: Martin Weltman, MBBS, PhD
Phone: +61 2 4734 2319
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Kissimmee, Florida 34759
Principal Investigator: Syed Mumtaz, MD
Phone: 407-932-1977
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La Jolla, California
Principal Investigator: Paul Pockros, MD
Phone: 858-336-4314
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La Jolla, California 92037
Principal Investigator: Rohit Loomba, MD, MHSc.
Phone: 858-246-0006
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Lakewood Ranch, Florida 34211
Principal Investigator: Guy Neff, MD
Phone: 941-727-7772
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Las Vegas, Nevada 89106
Principal Investigator: Vishweshwar Ranga, MD
Phone: 702-909-0217
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Little Rock, Arkansas 72205
Principal Investigator: Alonzo Williams, MD
Phone: 501-687-9300
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Live Oak, Texas 78233
Principal Investigator: Stephen Harrison, MD
Phone: 210-982-0320
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Los Angeles, California 90033
Principal Investigator: Liyan Yuan, MD
Phone: 323-442-8152
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Los Angeles, California 90048
Principal Investigator: Vinay Sundaram, MD
Phone: 310-423-4295
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Los Angeles, California 90073
Principal Investigator: Joseph Pisegna, MD
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323 East Chestnut Street
Louisville, Kentucky 40202
Louisville, Kentucky 40202
Principal Investigator: Matthew Cave, MD
Phone: 502-852-3383
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Madison, Wisconsin 53705
Principal Investigator: Adnan Said, MD
Phone: 608-262-5404
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Marietta, Georgia 30060
Principal Investigator: Aasim Sheikh, MD
Phone: 678-819-4221
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