Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo

PHASE2CompletedINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2014

Conditions
Crohn's Disease
Interventions
BIOLOGICAL

Trichuris suis ova (TSO)

TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)

BIOLOGICAL

Placebo

Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)

Trial Locations (73)

10016

Metropolitan Research Associates, New York

11021

Long Island Clinical Research Associates, LLP, Great Neck

12208

Albany Medical Center, Albany

14225

Digestive Health Physicians, Cheektowaga

15213

University of Pittsburgh Medical Center, Pittsburgh

15401

Cherry Tree Medical, Uniontown

15701

Shirish A. Amin, MD, PC, Indiana

18015

James J. Boylan Gastroenterology and Liver Diseases, Bethlehem

18840

Donald Guthrie Foundation for Education & Research, Sayre

22031

Gastroenterology Associates of Northern Virginia, Fairfax

23298

Virginia Commonwealth University Medical Center, Richmond

27103

Clinical Trials of America, Inc., Winston-Salem

27599

University of North Carolina, Chapel Hill

30024

Atlanta Gastroenterology Specialists, PC, Suwanee

32204

Borland-Groover Clinic, Jacksonville

32607

Florida Medical Research Institute, Gainesville

32720

Avail Clinical Research, LLC, DeLand

32789

Shafran Gastroenterology Center, Winter Park

33021

The Center for Gastrointestinal Disorders, Hollywood

33134

Sanitas Research, Coral Gables

33135

Paramount Public Health & Research Management Services, Miami

33155

Community Research Foundation, Inc, Miami

33319

Sunrise Medical Research, Lauderdale Lakes

33765

Clinical Research of West Florida, Clearwater

34102

Gastroenterology Group of Naples, Naples

34741

Gastroenterology Associates of Osceola, Kissimmee

37212

Vanderbilt University Medical Center, Nashville

40202

University of Louisville, Louisville

43210

The Ohio State University-Inflammatory Bowel Disease Ctr, Columbus

44060

Great Lakes Gastroenterology, Mentor

45219

Consultants for Clinical Research, Inc, Cincinnati

47714

Medisphere Medical Research Center, LLC, Evansville

48047

Clinical Research Institute of Michigan, LLC, Chesterfield

48109

University of Michigan Health Services, Ann Arbor

49009

Beyer Research, Kalamazoo

52242

University of Iowa Hospitals and Clinics, Iowa City

59101

Billings Clinic Research Center, Billings

60005

Northwest Gastroenterologists, Arlington Heights

60490

Suburban Clinical Research, Bolingbrook

60527

Suburban Clinical Research, Burr Ridge

60637

The University of Chicago Hospital, Chicago

64064

Midwest Center for Clinical Research, Lee's Summit

65265

Center for Digestive and Liver Disease, Mexico

66606

Cotton O'Neil Digestive Healthcare, Topeka

68114

Quality Clinical Research, Inc., Omaha

72205

Lynn Institue of the Ozarks, Little Rock

72211

Preferred Research Partners, Little Rock

74135

Gastroenterology United of Tulsa, Tulsa

77004

Diagnostic Clinic of Houston, Houston

77030

Baylor College of Medicine, Houston

78705

Austin Gastroenterology PA/Professional Quality Research, Inc, Austin

78758

Lovelace Scientific Resources, Inc., Austin

80026

Gastroenterology of the Rockies, Lafayette

83704

Selah Medical Center, Boise

85712

Visions Clinical Research - Tucson, Tucson

89434

Reno Clinical Trials, Sparks

90638

Medvin Clinical Research, La Mirada

90712

Lakewood Primary Care Medical Group, Inc, Lakewood

90804

Alliance Research, Long Beach

90806

Collaborative Neuroscience Network, Inc., Long Beach

91941

Rokay Kamyar, MD Inc, La Mesa

92056

Alliance Clinical Research, LLC, Oceanside

92120

San Diego Clinical Trials, San Diego

92801

Anaheim Clinical Trials, Anaheim

94070

Digestive Care Associates, San Carlos

97210

Northwest Gastroenterology Clinic, LLD, Portland

98801

Wenatchee Valley Medical Center, Wenatchee

336003

Clinical Research of West Florida, Inc., Tampa

02111

Tufts Medical Center, Boston

02115

Brigham and Women's Hospital, Boston

08012

South Jersey Medical Associates, P.A., Blackwood

07666

Holy Name Medical Center, Teaneck

02886

Omega Medical Research, Warwick

Sponsors
All Listed Sponsors
lead

Coronado Biosciences, Inc.

INDUSTRY