An Efficacy and Safety Study of SHP647 as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis
Status: | Recruiting |
---|---|
Conditions: | Colitis, Colitis, Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 16 - 81 |
Updated: | 3/30/2019 |
Start Date: | April 4, 2018 |
End Date: | November 28, 2021 |
Contact: | Shire Contact |
Email: | ClinicalTransparency@shire.com |
Phone: | +1 866 842 5335 |
A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)
The purpose of this study is to evaluate the efficacy of SHP647 as maintenance therapy
treatment of remission, based on composite score of patient-reported symptoms and centrally
read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
treatment of remission, based on composite score of patient-reported symptoms and centrally
read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
Inclusion Criteria:
- Participants and/or their parent or legally authorized representative must have an
understanding, ability, and willingness to fully comply with study procedures and
restrictions.
- Participants must be able to voluntarily provide written, signed, and dated
(personally or via a legally authorized representative) informed consent and/or
assent, as applicable, to participate in the study.
- Participants must have completed the 12-week induction treatment period (SHP647-301
[NCT03259334] and SHP647-302 [NCT03259308]).
- Participants must have achieved clinical response in induction study (SHP647-301
[NCT03259334] and SHP647-302 [NCT03259308]). Clinical response is defined as:
1. A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302
[NCT03259308]) baseline in the composite score of patient-reported symptoms using
daily e-diary and centrally read endoscopy of at least 2 points and at least 30
percent (%), with an accompanying decrease in the subscore for rectal bleeding
greater than or equal to (>=)1 point or a subscore for rectal bleeding less than
or equal to (<=) 1 OR
2. A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302
[NCT03259308]) baseline in total Mayo score of at least 3 points and at least
30%, with an accompanying decrease in the rectal bleeding subscore of at least 1
point or an absolute rectal bleeding subscore of 0 or 1.
For eligibility assessment, clinical response will be determined based on the centrally
read endoscopy performed during screening and at Week 12 of induction study (SHP647-301
[NCT03259334] and SHP647-302 [NCT03259308]).
- Participants receiving any treatment(s) for ulcerative colitis (UC) are eligible
provided they have been, and are anticipated to be, on a stable dose for the
designated period of time.
Exclusion Criteria:
- Participants who had major protocol deviation(s) (as determined by the sponsor) in
induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
- Participants who permanently discontinued investigational product because of an
adverse event (AE), regardless of relatedness to investigational product, in induction
study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
- Participants who are likely to require surgery for UC during the study period.
- Participants are females who became pregnant during induction study (SHP647-301
[NCT03259334] and SHP647-302 [NCT03259308]), females who are planning to become
pregnant during the study period, or males or females of childbearing potential not
agreeing to continue using appropriate contraception methods through the conclusion of
study participation.
- Participants who do not agree to postpone donation of any organ or tissue, including
male participants who are planning to bank or donate sperm and female participants who
are planning to harvest or donate eggs, for the duration of the study and through 16
weeks after last dose of investigational product.
- Participants who, in the opinion of the investigator or the sponsor, will be
uncooperative or unable to comply with study procedures.
- Participants who have a newly diagnosed malignancy or recurrence of malignancy (other
than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in
situ of the uterine cervix that has been treated with no evidence of recurrence).
- Participants who have developed any major illness/condition or evidence of an unstable
clinical condition (example [eg], renal, hepatic, hematologic, gastrointestinal
(except disease under study), endocrine, cardiovascular, pulmonary, immunologic [eg,
Felty's syndrome], or local active infection/infectious illness) that, in the
investigator's judgment, will substantially increase the risk to the participant if he
or she participates in the study.
- Participants with any other severe acute or chronic medical or psychiatric condition
or laboratory or electrocardiogram (ECG) abnormality that may increase the risk
associated with study participation or investigational product administration or may
interfere with the interpretation of study results and, in the judgment of the
investigator, would make the participant inappropriate for entry into this study.
- Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at
screening in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308])
and who are without a generally accepted course of treatment.
- Participants who are investigational site staff members or relatives of those site
staff members or participants who are sponsor employees directly involved in the
conduct of the study.
- Participants who are participating in or plan to participate in other investigational
studies (other than induction study) during study (SHP647-301 [NCT03259334] and
SHP647-302 [NCT03259308]).
We found this trial at
99
sites
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185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Ashwin Ananthakrishnan
Phone: 617-724-3238
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85 S Prospect St
Burlington, Vermont 5405
Burlington, Vermont 5405
(802) 656-3131
Principal Investigator: Peter Moses
Phone: 802-847-8865
University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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1200 Moursund Street
Houston, Texas 77030
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Manreet Kaur
Phone: 713-798-6342
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
Jacksonville, Florida 32256
Principal Investigator: Mark Fleisher, MD
Phone: 904-680-0871
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8420 S. Eastern Ave.
Las Vegas, Nevada 89123
Las Vegas, Nevada 89123
702-898-2088
Principal Investigator: Vrijendra Hoon, MD
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1601 Northwest 12th Avenue
Miami, Florida 33136
Miami, Florida 33136
(305) 243-6545
Principal Investigator: David Kerman
Phone: 305-243-2910
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Dawn Beaulieu, MD
Phone: 615-322-4643
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Scott Lee
Phone: 206-598-4377
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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500 S State St
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Peter Higgins, MD, MSc, PhD
Phone: 734-764-0507
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Atlanta, Georgia 30308
Principal Investigator: Bruce Salzberg, MD
Phone: 678-957-0057
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Bountiful, Utah 84010
Principal Investigator: Val Hansen, MD
Phone: 801-797-9315
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Brooklyn, New York 11215
Principal Investigator: Jorge Serje, MD
Phone: 718-499-6099
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Cape Coral, Florida 33991
Principal Investigator: Alfonso Garcia Bello, MD
Phone: 239-800-4893
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Chesterfield, Michigan 48047
Principal Investigator: Ronald Fogel, MD
Phone: 586-598-3329
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Chevy Chase, Maryland 20815
Principal Investigator: Louis Korman, MD
Phone: 301-652-5520
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303 East Superior Street
Chicago, Illinois 60611
Chicago, Illinois 60611
Principal Investigator: Stephen Hanauer
Phone: 312-695-4929
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5841 S Maryland Ave
Chicago, Illinois 60637
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: David Rubin
Phone: 773-834-7414
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Cincinnati, Ohio 45219
Principal Investigator: Christopher South, MD
Phone: 513-751-6667
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Colorado Springs, Colorado 80907
Principal Investigator: Bhaktasharan Patel, MD
Phone: 719-636-1201
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2709 North Tejon Street
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
Principal Investigator: Daniel Soteres, MD
Phone: 719-473-0872
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Columbus, Georgia 31904
Principal Investigator: Pravinchandra Patel, MD
Phone: 888-737-7499
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967 North University Drive
Coral Springs, Florida 33071
Coral Springs, Florida 33071
Principal Investigator: Vipin Gupta, BS, MB, MD
Phone: 954-428-2480
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Corona, California 92879
Principal Investigator: M. Mazen Jamal, MD
Phone: 951-220-4029
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21212 Northwest Freeway
Cypress, Texas 77429
Cypress, Texas 77429
Principal Investigator: Ayub Hussain, MD
Phone: 281-477-9305
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Decatur, Georgia 30033
Principal Investigator: David Rausher, MD
Phone: 404-296-1986
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Duluth, Minnesota 55805
Principal Investigator: Michael Van Norstrand
Phone: 608-782-9760
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Elkins, West Virginia 26241
Principal Investigator: Nitesh Ratnakar, MD
Phone: 304-216-2411
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Encinitas, California 92024
Principal Investigator: Piyush (Phil) Kumar, MD
Phone: 760-274-2704
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420 Grand Avenue
Englewood, New Jersey 07631
Englewood, New Jersey 07631
Principal Investigator: Kenneth Rubin
Phone: 201-569-7044
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Evansville, Indiana 47714
Principal Investigator: Alexander Dela Llana, MD
Phone: 812-471-4110
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2925 Vernon Place
Fairfield, Ohio 45014
Fairfield, Ohio 45014
Principal Investigator: Jeffrey Stotz, MD
Phone: 513-860-4801
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425 Centre View Boulevard
Florence, Kentucky 41042
Florence, Kentucky 41042
Principal Investigator: Michael Jones
Phone: 859-594-4626
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Franklin, Ohio 45005
Principal Investigator: Gary Bedel, MD
Phone: 937-746-4505
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103 Doctor's Place
Galax, Virginia 24333
Galax, Virginia 24333
Principal Investigator: Robert Benish, MD
Phone: 276-236-2947
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Great Neck, New York 11021
Principal Investigator: Seymour Katz
Phone: 516-466-2340
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20 Tower Court
Gurnee, Illinois 60031
Gurnee, Illinois 60031
Principal Investigator: Fred Rosenberg, MD
Phone: 847-604-8700
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200 Medical Center Drive
Hazard, Kentucky 41701
Hazard, Kentucky 41701
Principal Investigator: Uday Shankar, MD
Phone: 606-439-3952
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Hines, Illinois 60141
Principal Investigator: Marmy Shah
Phone: 914-960-1653
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24035 Three Notch Road
Hollywood, Maryland 20636
Hollywood, Maryland 20636
Principal Investigator: Anil Kankaria
Phone: 301-373-7500
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Houma, Louisiana 70360
Principal Investigator: Nathaniel Winstead, MD
Phone: 985-601-2662
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19255 Park Row Drive
Houston, Texas 77084
Houston, Texas 77084
Principal Investigator: Mouhamad Al-Sabbagh, MD
Phone: 281-768-5879
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15035 East Freeway
Houston, Texas 77530
Houston, Texas 77530
Principal Investigator: Darshan Anandu, MD
Phone: 888-888-8888
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Houston, Texas 77074
Principal Investigator: Dilawar Ajani, MD
Phone: 281-216-3658
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Jacksonville, North Carolina 28546
Principal Investigator: Peter Eweje, MD
Phone: 910-353-6158
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4801 E Linwood Blvd # 103
Kansas City, Missouri 64128
Kansas City, Missouri 64128
Principal Investigator: Tarun Rai
Phone: 816-861-4700
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Kissimmee, Florida 34759
Principal Investigator: Syed Mumtaz, MBBS, MD
Phone: 407-964-1207
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9500 Gilman Dr
La Jolla, California 92093
La Jolla, California 92093
(858) 534-2230
Principal Investigator: William Sandborn, MD
Phone: 858-657-6338
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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1 Lakeshore Drive
Lake Charles, Louisiana 70601
Lake Charles, Louisiana 70601
Principal Investigator: Ricardo McCall, MD
Phone: 337-493-5310
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Lancaster, California 93534
Principal Investigator: Jatinder Pruthi, MD
Phone: 310-684-2494
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Little Rock, Arkansas 72209
Principal Investigator: Meenakshi Budhraja, MD
Phone: 501-492-9175
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Long Beach, California 90822
Principal Investigator: Robert Lee
Phone: 562-826-8000
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Mentor, Ohio 44060
Principal Investigator: Franjo Vladic, MD
Phone: 440-205-5740
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Mesa, Arizona 85206
Principal Investigator: Doo-Sang Cho, MD
Phone: 480-889-1211
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Miami, Florida 33144
Principal Investigator: Carlos Vaca, MD
Phone: 305-551-8493
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Miami, Florida 33176
Principal Investigator: Gil Fernandez-Yera, MD
Phone: 305-702-1594
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Michigan City, Indiana 46360
Principal Investigator: Minesh Patel, MD
Phone: 219-879-0333
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Mission Hills, California 91345
Principal Investigator: Magued Beshay, MD
Phone: 818-837-7067
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Morgantown, West Virginia
Principal Investigator: Justin Kupec, MD
Phone: 304-293-4123
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28078 Baxter Road
Murrieta, California 92563
Murrieta, California 92563
Principal Investigator: John Hong
Phone: 714-668-1500
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Naples, Florida 34110
Principal Investigator: Steven Meckstroth, MD
Phone: 239-631-2989
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Naples, Florida 34102
Principal Investigator: Raymond Phillips, MD
Phone: 239-649-1186
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New York, New York 10021
Principal Investigator: Ellen Scherl
Phone: 212-746-5077
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2 Trans Am Plaza Drive
Oakbrook Terrace, Illinois 60181
Oakbrook Terrace, Illinois 60181
Principal Investigator: Matthew Smith, MD
Phone: 630-833-0653
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Ocean Springs, Mississippi 39564
Principal Investigator: Alfred McNair, Jr., MD
Phone: 228-872-7612
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921 Northeast 13th Street
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Principal Investigator: Mohammad Madhoun
Phone: 405-361-9482
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310 Sterling Drive
Orchard Park, New York 14127
Orchard Park, New York 14127
Principal Investigator: Albert Diaz-Ordaz, MD
Phone: 206-661-0073
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Orlando, Florida 32804
Principal Investigator: Kwabena Ayesu, MD
Phone: 407-271-8030
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Phoenix, Arizona 85018
Principal Investigator: Joseph Lillo, DO
Phone: 602-788-3437
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Pinellas Park, Florida 33781
Principal Investigator: Venkata Iyunni, MD
Phone: 727-546-1680
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Pittsburgh, Pennsylvania 15212
Principal Investigator: Sandra El-Hachem
Phone: 412-359-8900
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Pittsburgh, Pennsylvania 15240
Principal Investigator: Fadi Fouad Francis
Phone: 412-360-3788
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Plantation, Florida 33322
Principal Investigator: Catherine Popkin, MD
Phone: 208-346-8905
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Rialto, California 92377
Principal Investigator: Zeid Kayali, MBA, MD
Phone: 909-883-2999
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Saint Augustine, Florida 32086
Principal Investigator: Anis Ahmadi, MD
Phone: 904-824-1776
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Saint Louis, Missouri 63110
Principal Investigator: Matthew Ciorba
Phone: 314-362-9039
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Saint Louis, Missouri 63128
Principal Investigator: James Dimitroff, MD
Phone: 314-543-5225
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150 East Sonterra Boulevard
San Antonio, Texas 78229
San Antonio, Texas 78229
Principal Investigator: Jeff Bullock, MD
Phone: 210-558-2794
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San Diego, California 92130
Principal Investigator: Mazer Ally, MD
Phone: 202-460-9111
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San Francisco, California 94143
Principal Investigator: Melvin Heyman, MD
Phone: 415-476-0820
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372 25 de Mayo
San Miguel De Tucumán, Tucumán 4000
San Miguel De Tucumán, Tucumán 4000
Principal Investigator: Jorge Fernández
Phone: +543814301305
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San Pablo, California 94806
Principal Investigator: Mark Kogan, MD
Phone: 415-408-8734
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1959 Northeast Pacific Street
Seattle, Washington 98195
Seattle, Washington 98195
Principal Investigator: Timothy Zisman
Phone: 206-598-4377
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Shreveport, Louisiana 71103
Principal Investigator: Humberto Aguilar, MD
Phone: 318-525-3233
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759 Chestnut Street
Springfield, Massachusetts 01199
Springfield, Massachusetts 01199
(413) 794 - 0000
Principal Investigator: Rohit Singhania
Phone: 413-794-7364
Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...
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Statesville, North Carolina 28677
Principal Investigator: Vivek Trivedi, MD
Phone: 704-873-4277
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Sun City, Arizona 85351
Principal Investigator: Chirag Trivedi
Phone: 602-264-9100
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1112 6th Avenue
Tacoma, Washington 98405
Tacoma, Washington 98405
Principal Investigator: Steven Larson, MD
Phone: 253-272-8664
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Tomball, Texas 77375
Principal Investigator: Muhammad Irfan, MD
Phone: 281-517-0550
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Tucson, Arizona 85710
Principal Investigator: Gary Gottlieb
Phone: 520-547-3020
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1109 East Reelfoot Avenue
Union City, Tennessee 38261
Union City, Tennessee 38261
Principal Investigator: Kofi Nuako, MD
Phone: 731-884-0600
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451 North Texas Avenue
Webster, Texas 77598
Webster, Texas 77598
Principal Investigator: Advitya Malhotra, MD
Phone: 281-557-2527
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Winchester, Massachusetts 22601
Principal Investigator: Nicholas Snow, MD
Phone: 540-667-1244
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Worcester, Massachusetts 01605
Principal Investigator: Jean Marie Houghton, MD
Phone: 774-442-4098
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Wyomissing, Pennsylvania 19610
Principal Investigator: Nirav Shah, MD
Phone: 610-374-4401
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