A Safety Extension Study of SHP647 in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:16 - 80
Updated:4/6/2019
Start Date:February 27, 2018
End Date:June 3, 2025
Contact:Shire Contact
Email:ClinicalTransparency@shire.com
Phone:+1 866 842 5335

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A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

The purpose of this study is to evaluate the safety and tolerability of long-term treatment
with SHP647 in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's
disease (CD).


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 with Ulcerative Colitis:

- Participants must have been previously enrolled in study SHP647-301 (NCT03259334),
SHP647-302 (NCT03259308), or SHP647-303 (NCT03290781), and reached 1 of the following
clinical trial milestones:

1. Completed the Week 12 visit in induction study SHP647-301 (NCT03259334) or
SHP647-302 (NCT03259308), and did not achieve a clinical response. Clinical
response is defined as: 1. a decrease from 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] or SHP647-302 [NCT03259308]) baseline
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.

2. Completed the Week 52 visit in maintenance study SHP647-303 (NCT03290781).

3. Withdrew early from maintenance study SHP647-303 (NCT03290781) due to treatment
failure, defined by an endoscopic subscore that has increased by at least 1 point
over baseline in the maintenance study or a value >= 2 plus an increase in
clinical subscore (stool frequency + rectal bleeding score) of at least 2 points.
Centrally read endoscopic subscores will be used to determine treatment failure.

- Participants receiving any treatment(s) for UC are eligible provided they have been,
and are anticipated to be, on a stable dose for the designated period of time.

Participants with Crohn's Disease:

- Participants must have been previously enrolled in study SHP647-305, SHP647-306, or
SHP647-307, and reached 1 of the following clinical trial milestones:

1. Completed the Week 16 visit in induction study SHP647-305 or SHP647-306, and did
NOT meet the efficacy criteria (clinical and/or endoscopic response/remission as
appropriate) for entry into maintenance study SHP647-307.

2. Completed the Week 52 visit in maintenance study SHP647-307.

3. Withdrew early from maintenance study SHP647-307 due to treatment failure (or
were considered to have failed treatment, at the time of the last visit in study
SHP647-307), as defined in the SHP647-307 protocol.

- Participants receiving any treatment(s) for CD are eligible provided they have been,
and are anticipated to be, on a stable dose for the designated period of time.

Exclusion Criteria:

Participants with Ulcerative Colitis:

- Participants who had major protocol deviation(s) (as determined by the sponsor) in
study SHP647-301 (NCT03259334), SHP647-302 (NCT03259308), or SHP647-303 (NCT03290781).

- Participants who permanently discontinued investigational product because of an AE,
regardless of relatedness to investigational product, in study SHP647-301
(NCT03259334), SHP647-302 (NCT03259308), or SHP647-303 (NCT03290781).

- Participants who are likely to require major surgery for UC.

- Participants are females who became pregnant during study SHP647-301 (NCT03259334),
SHP647-302 (NCT03259308), or SHP647-303 (NCT03290781), 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 study SHP647-301 (NCT03259334) or SHP647-302 (NCT03259308) and who have
been advised to require treatment for latent or active disease, but 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 other investigational studies (other than
SHP647-301 [NCT03259334], SHP647-302 (NCT03259308), or SHP647-303 [NCT03290781]) or
plan to participate in other investigational studies during long-term extension study
SHP647-304.

Participants with Crohn's Disease:

- Participants who had major protocol deviation(s) (as determined by the sponsor) in
study SHP647-305, SHP647-306, or SHP647-307.

- Participants who permanently discontinued investigational product because of an
adverse events (AE), regardless of relatedness to investigational product, in study
SHP647-305, SHP647-306, or SHP647-307.

- Participants who are likely to require major surgery for CD or developed acute severe
complications of CD (with or without fulfilling the treatment failure criteria in the
maintenance study) that required immediate intervention (eg, need for immediate
biologic treatment with proven effect) and/or Crohn's Disease Activity Index (CDAI)
score more than (>) 450.

- Participants are females who became pregnant during study SHP647-305, SHP647-306, or
SHP647-307, females who are planning to become pregnant during the study period, or
males or females of childbearing potential not agreeing to continue 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 (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 study SHP647-305 or SHP647-306 and who have been advised to require
treatment for latent or active disease, but 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 other investigational studies (other than
SHP647-305, SHP647-306, or SHP647-307) or plan to participate in other investigational
studies during long-term extension study SHP647-304.
We found this trial at
106
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967 North University Drive
Coral Springs, Florida 33071
Principal Investigator: Vipin Gupta, BS, MB, MD
Phone: 954-428-2480
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185 Cambridge Street
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
(802) 656-3131
Principal Investigator: Peter Moses
Phone: 802-847-8865
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Manreet Kaur
Phone: 713-798-6342
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
Principal Investigator: Mark Fleisher, MD
Phone: 904-680-0871
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8420 S. Eastern Ave.
Las Vegas, Nevada 89123
702-898-2088
Principal Investigator: Vrijendra Hoon, MD
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
Principal Investigator: David Kerman
Phone: 305-243-2910
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Dawn Beaulieu, MD
Phone: 615-322-4643
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Seattle, Washington 98104
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Phone: 206-598-4377
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823 SW Mulvane St
Topeka, Kansas 66606
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Peter Higgins, MD, MSc, PhD
Phone: 734-764-0507
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: David Rubin, MD
Phone: 773-834-7414
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Cincinnati, Ohio 45219
Principal Investigator: Christopher South, MD
Phone: 513-751-6667
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Clearwater, Florida 33762
Principal Investigator: L Weiss, MD
Phone: 727-347-0536
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Principal Investigator: Bhaktasharan Patel, MD
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2709 North Tejon Street
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Columbus, Georgia 31904
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Corona, California 92879
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21212 Northwest Freeway
Cypress, Texas 77429
Principal Investigator: Ayub Hussain, MD
Phone: 281-477-9305
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Decatur, Georgia 30033
Principal Investigator: David Rausher, MD
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Duluth, Minnesota 55805
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Elkins, West Virginia 26241
Principal Investigator: Nitesh Ratnakar, MD
Phone: 304-216-2411
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420 Grand Avenue
Englewood, New Jersey 07631
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Evansville, Indiana 47714
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2925 Vernon Place
Fairfield, Ohio 45014
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425 Centre View Boulevard
Florence, Kentucky 41042
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Franklin, Ohio 45005
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103 Doctor's Place
Galax, Virginia 24333
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Germantown, Tennessee 38138
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Great Neck, New York 11021
Principal Investigator: Seymour Katz, MD
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20 Tower Court
Gurnee, Illinois 60031
Principal Investigator: Fred Rosenberg, MD
Phone: 847-604-8700
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200 Medical Center Drive
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
Principal Investigator: Anil Kankaria
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Houma, Louisiana 70360
Principal Investigator: Nathaniel Winstead, MD
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Houston, Texas 77025
Principal Investigator: Greg Galler
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7312 Louetta Road
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19255 Park Row Drive
Houston, Texas 77084
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Phone: 281-768-5879
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15035 East Freeway
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Principal Investigator: Darshan Anandu, MD
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Houston, Texas 77084
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4801 E Linwood Blvd # 103
Kansas City, Missouri 64128
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
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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
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28078 Baxter Road
Murrieta, California 92563
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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
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New Orleans, Louisiana 70115
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Phone: 504-336-2667
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New York, New York 10021
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2 Trans Am Plaza Drive
Oakbrook Terrace, Illinois 60181
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Ocean Springs, Mississippi 39564
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921 Northeast 13th Street
Oklahoma City, Oklahoma 73104
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310 Sterling Drive
Orchard Park, New York 14127
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Orlando, Florida 32806
Principal Investigator: Linda Harper
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Orlando, Florida 32804
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Phoenix, Arizona 85018
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Pinellas Park, Florida 33781
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Pittsburgh, Pennsylvania 15212
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Pittsburgh, Pennsylvania 15240
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Plantation, Florida 33322
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Rialto, California 92377
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Saint Augustine, Florida 32086
Principal Investigator: Anis Ahmadi, MD
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Saint Louis, Missouri 63128
Principal Investigator: James Dimitroff, MD
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: George Christophi
Phone: 314-273-1947
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Saint Paul, Minnesota 55114
Principal Investigator: Robert McCabe, Jr.
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150 East Sonterra Boulevard
San Antonio, Texas 78229
Principal Investigator: Jeff Bullock, MD
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San Diego, California 92130
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San Francisco, California 94143
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372 25 de Mayo
San Miguel De Tucumán, Tucumán 4000
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San Pablo, California 94806
Principal Investigator: Mark Kogan, MD
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1959 Northeast Pacific Street
Seattle, Washington 98195
Principal Investigator: Timothy Zisman, MD
Phone: 206-598-4377
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Seattle, WA
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Shreveport, Louisiana 71103
Principal Investigator: Humberto Aguilar, MD
Phone: 318-525-3233
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Shreveport, LA
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759 Chestnut Street
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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Springfield, MA
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State College, Pennsylvania 16803
Principal Investigator: Joel Haight, MD
Phone: 814-272-4445
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State College, PA
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Statesville, North Carolina 28677
Principal Investigator: Vivek Trivedi, MD
Phone: 704-873-4277
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Statesville, NC
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Sun City, Arizona 85351
Principal Investigator: Chirag Trivedi
Phone: 602-264-9100
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Sun City, AZ
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1112 6th Avenue
Tacoma, Washington 98405
Principal Investigator: Steven Larson, MD
Phone: 253-272-8664
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Tacoma, WA
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Tamarac, Florida 33321
Principal Investigator: Kevin Bender, MD
Phone: 954-537-2100
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Tamarac, FL
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Tomball, Texas 77375
Principal Investigator: Muhammad Irfan, MD
Phone: 281-517-0550
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Tomball, TX
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Tucson, Arizona 85710
Principal Investigator: Gary Gottlieb
Phone: 520-547-3020
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Tucson, AZ
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1109 East Reelfoot Avenue
Union City, Tennessee 38261
Principal Investigator: Kofi Nuako, MD
Phone: 731-884-0600
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Union City, TN
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451 North Texas Avenue
Webster, Texas 77598
Principal Investigator: Advitya Malhotra, MD
Phone: 281-557-2527
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Webster, TX
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