ClinicalTrials.gov

History of Changes for Study: NCT03201445
Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease (MANTA)
Latest version (submitted July 8, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 26, 2017 None (earliest Version on record)
2 July 19, 2017 Recruitment Status, Study Status and Contacts/Locations
3 August 15, 2017 Study Status, Eligibility, Arms and Interventions and Study Design
4 September 11, 2017 Contacts/Locations and Study Status
5 October 2, 2017 Study Status, Contacts/Locations and Study Identification
6 October 26, 2017 Contacts/Locations and Study Status
7 December 1, 2017 Study Status and Contacts/Locations
8 January 10, 2018 Contacts/Locations and Study Status
9 February 12, 2018 Study Status and Contacts/Locations
10 March 13, 2018 Contacts/Locations and Study Status
11 April 4, 2018 Study Status and Contacts/Locations
12 May 14, 2018 Study Status and Contacts/Locations
13 June 8, 2018 Study Status and Contacts/Locations
14 July 6, 2018 Study Status and Contacts/Locations
15 August 2, 2018 Study Status and Contacts/Locations
16 August 30, 2018 Contacts/Locations and Study Status
17 September 25, 2018 Study Status and Contacts/Locations
18 October 10, 2018 Contacts/Locations and Study Status
19 October 29, 2018 Contacts/Locations and Study Status
20 November 16, 2018 Study Status and Contacts/Locations
21 December 6, 2018 Study Status and Contacts/Locations
22 January 7, 2019 Study Status and Contacts/Locations
23 January 28, 2019 Contacts/Locations and Study Status
24 February 25, 2019 Study Status and Contacts/Locations
25 March 12, 2019 Study Status and Contacts/Locations
26 April 2, 2019 Contacts/Locations and Study Status
27 June 3, 2019 Arms and Interventions, Eligibility, Contacts/Locations, Study Status, Study Identification, Conditions and Study Description
28 June 24, 2019 Contacts/Locations and Study Status
29 July 17, 2019 Contacts/Locations and Study Status
30 August 6, 2019 Contacts/Locations and Study Status
31 August 23, 2019 Study Status
32 September 11, 2019 Contacts/Locations and Study Status
33 September 30, 2019 Contacts/Locations and Study Status
34 October 21, 2019 Contacts/Locations and Study Status
35 November 11, 2019 Study Status
36 November 26, 2019 Contacts/Locations and Study Status
37 December 12, 2019 Study Status and Contacts/Locations
38 January 9, 2020 Contacts/Locations and Study Status
39 January 31, 2020 Contacts/Locations and Study Status
40 February 27, 2020 Contacts/Locations and Study Status
41 April 14, 2020 Contacts/Locations and Study Status
42 May 8, 2020 Contacts/Locations and Study Status
43 May 28, 2020 Contacts/Locations and Study Status
44 June 22, 2020 Study Status
45 July 8, 2020 Study Status and Contacts/Locations
Comparison Format:

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Changes (Side-by-Side) for Study: NCT03201445
April 2, 2019 (v26) -- June 3, 2019 (v27)

Changes in: Arms and Interventions, Eligibility, Contacts/Locations, Study Status, Study Identification, Conditions and Study Description

Study Identification
Unique Protocol ID: GS-US-418-4279 GS-US-418-4279
Brief Title: Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Ulcerative Colitis (MANTA)Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease (MANTA)
Official Title: A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Ulcerative Colitis A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease
Secondary IDs: 2017-000402-38 [EudraCT Number]2017-000402-38 [EudraCT Number]
Study Status
Record Verification: April 2019 June 2019
Overall Status: Recruiting Recruiting
Study Start: July 11, 2017 July 11, 2017
Primary Completion: January 2021 [Anticipated ] January 2021 [Anticipated ]
Study Completion: October 2024 [Anticipated ] October 2024 [Anticipated ]
First Submitted: June 26, 2017 June 26, 2017
First Submitted that
Met QC Criteria:
June 26, 2017 June 26, 2017
First Posted: June 28, 2017 [Actual ] June 28, 2017 [Actual ]
Last Update Submitted that
Met QC Criteria:
April 2, 2019 June 3, 2019
Last Update Posted: April 4, 2019 [Actual ] June 5, 2019 [Actual ]
Sponsor/Collaborators
Sponsor: Gilead Sciences Gilead Sciences
Responsible Party: Sponsor Sponsor
Collaborators: Galapagos NV Galapagos NV
Oversight
U.S. FDA-regulated Drug: Yes Yes
U.S. FDA-regulated Device: No No
Data Monitoring: Yes Yes
Study Description
Brief Summary: The primary objective of this study is to evaluate the testicular safety of filgotinib in adult males with moderately to severely active ulcerative colitis.

The primary objective of this study is to evaluate the testicular safety of filgotinib in adult males with moderately to severely active inflammatory bowel disease.

Results of this study may be pooled with the results of a separate study being conducted in participants with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis (Protocol GLPG0634-CL-227; NCT03926195) with the same objective. The total planned number of participants in both studies combined will be up to approximately 250 participants.

Detailed Description:
Conditions
Conditions: Ulcerative Colitis Inflammatory Bowel Disease
Keywords:
Study Design
Study Type: InterventionalInterventional
Primary Purpose: TreatmentTreatment
Study Phase: Phase 2Phase 2
Interventional Study Model: Parallel Assignment Parallel Assignment
Number of Arms: 44
Masking: Double (Participant, Investigator)Double (Participant, Investigator)
Allocation: RandomizedRandomized
Enrollment: 250 [Anticipated ] 250 [Anticipated ]
Arms and Interventions
Arms Assigned Interventions
Experimental: Long Term Extension Phase Experimental: Part A and Part B (Filgotinib or Placebo)
After Week 26, participants who did not experience a decrease of ≥ 50% in sperm concentration from baseline will have the option to enter into the long-term extension (LTE) phase of the study. Responders will continue on the same blinded study drug and non-responders will continue to receive open-label filgotinib for an additional 195 weeks. Participants will receive double-blind filgotinib or placebo for 13 weeks in Part A. Based on inflammatory bowel disease response status and sperm parameters, participants will continue on the blinded treatment for up to an additional 13 weeks in Part B or discontinue blinded study drug and commence open-label filgotinib.
Drug: Filgotinib
200 mg tablet administered orally once daily
Drug: Placebo
Tablet administered orally once daily
Experimental: Double-Blind Open-Label Filgotinib Phase
Participants will receive open-label filgotinib for up to 26 13 weeks.
Drug: Filgotinib
200 mg tablet administered orally once daily
Experimental: Monitoring Phase
Participants with ≥ 50% decline in sperm concentration will receive standard of care therapy in the monitoring phase Participants whose sperm parameters meet a pre- specified decrease threshold at any time during the study, regardless of inflammatory bowel disease response status, will discontinue study drug and receive standard of care therapy in the Monitoring Phase.
Drug: Standard of Care
Standard of care therapy
Placebo Comparator: Double-Blind Placebo Experimental: Long Term Extension Phase
Placebo for up to 26 weeks Participants qualifying to enter the Long Term Extension Phase will receive either open-label filgotinib or blinded study drug for up to 195 weeks based on the individual's response criteria.
Drug: Filgotinib
200 mg tablet administered orally once daily
Drug: Placebo
Tablet administered orally once daily
Outcome Measures
Primary Outcome Measures:
1. Proportion of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13
Week 13
Proportion of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13
Week 13
Secondary Outcome Measures:
2. Proportion of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26
Week 26
Proportion of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26
Week 26
3. Change From Baseline in Percent Motile Sperm at Week 13
Week 13
Change From Baseline in Percent Motile Sperm at Week 13
Week 13
4. Change From Baseline in Percent Motile Sperm at Week 26
Week 26
Change From Baseline in Percent Motile Sperm at Week 26
Week 26
5. Change From Baseline in Total Sperm Count at Week 13
Week 13
Change From Baseline in Total Sperm Count at Week 13
Week 13
6. Change From Baseline in Total Sperm Count at Week 26
Week 26
Change From Baseline in Total Sperm Count at Week 26
Week 26
7. Change From Baseline in Sperm Concentration at Week 13
Week 13
Change From Baseline in Sperm Concentration at Week 13
Week 13
8. Change From Baseline in Sperm Concentration at Week 26
Week 26
Change From Baseline in Sperm Concentration at Week 26
Week 26
9. Change from Baseline in Ejaculate Volume at Week 13
Week 13
Change from Baseline in Ejaculate Volume at Week 13
Week 13
10. Change from Baseline in Ejaculate Volume at Week 26
Week 26
Change from Baseline in Ejaculate Volume at Week 26
Week 26
11. Change from Baseline in Percent Normal Sperm Morphology at Week 13
Week 13
Change from Baseline in Percent Normal Sperm Morphology at Week 13
Week 13
12. Change from Baseline in Percent Normal Sperm Morphology at Week 26
Week 26
Change from Baseline in Percent Normal Sperm Morphology at Week 26
Week 26
Eligibility
Minimum Age: 25 Years 21 Years
Maximum Age: 55 Years 65 Years
Sex: Male Male
Gender Based:
Accepts Healthy Volunteers: NoNo
Criteria:

Key Inclusion Criteria:

  • Male participants who are between the ages of 25 and 55 (inclusive) on the day of signing informed consent
  • Documented diagnosis of ulcerative colitis (UC) of at least 4 months AND with a minimum disease extent of 15 cm from the anal verge. Documentation should include endoscopic and histopathologic evidence of UC
  • Have moderately to severely active UC

Key Exclusion Criteria:

  • Previously documented problems with male reproductive health
  • Prior diagnosis of male infertility
  • Presence of Crohn's disease (CD), indeterminate colitis, ischemic colitis, fulminant colitis, isolated ulcerative proctitis, or toxic mega-colon
  • Active tuberculosis (TB) or history of latent TB that has not been treated
  • Use of concomitant prohibited medications as outlined by protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Key Inclusion Criteria:

  • Male participants who are between the ages of 21 and 65 (inclusive) on the day of signing informed consent
  • Documented diagnosis of ulcerative colitis (UC) or Crohn's Disease (CD) of at least 4 months. Endoscopic and histopathologic documentation of UC or CD.
  • Have moderately to severely active UC or CD

Key Exclusion Criteria:

  • Previously or currently documented problems with male reproductive health
  • Current use of sulfasalazine or its use within the 26 weeks leading up to Screening; sulfasalazine is not permitted at any point during the study
  • Current use of corticosteroids at a dosage of > 20 mg/day of prednisone or equivalent at randomization
  • Indeterminate colitis, ischemic colitis, fulminant colitis, isolated ulcerative proctitis, or toxic mega colon
  • Active tuberculosis (TB) or untreated latent tuberculosis
  • Use of concomitant prohibited medications as outlined by protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Contacts/Locations
Central Contact: Gilead Clinical Study Information Center
Telephone: 1-833-445-3230 (GILEAD-0)
Email: GileadClinicalTrials@gilead.com
Gilead Clinical Study Information Center
Telephone: 1-833-445-3230 (GILEAD-0)
Email: GileadClinicalTrials@gilead.com
Study Officials: Gilead Study Director
Study Director
Gilead Sciences
Gilead Study Director
Study Director
Gilead Sciences
Locations: United States, CaliforniaUnited States, California
Naval Medical Center San Diego
[Recruiting]
San Diego, California, United States, 92134
Naval Medical Center San Diego
[Recruiting]
San Diego, California, United States, 92134
Clearview Medical Research, LLC
[Recruiting]
Santa Clarita, California, United States, 91351
Clearview Medical Research, LLC
[Recruiting]
Santa Clarita, California, United States, 91351
United States, FloridaUnited States, Florida
Nirvana Research Center
[Recruiting]
Doral, Florida, United States, 33166
Nirvana Research Center
[Recruiting]
Doral, Florida, United States, 33166
Universal Axon Clinical Research
[Recruiting]
Doral, Florida, United States, 33166
Universal Axon Clinical Research
[Recruiting]
Doral, Florida, United States, 33166
University of Florida
[Recruiting]
Gainesville, Florida, United States, 32610
University of Florida
[Recruiting]
Gainesville, Florida, United States, 32610
Florida Research Institute
[Recruiting]
Lakewood Ranch, Florida, United States, 34211
Florida Research Institute
[Recruiting]
Lakewood Ranch, Florida, United States, 34211
University of Miami Crohn's and Colitis Center
[Recruiting]
Miami, Florida, United States, 33136
University of Miami Crohn's and Colitis Center
[Recruiting]
Miami, Florida, United States, 33136
L&C Professional Medical Research Institute
[Recruiting]
Miami, Florida, United States, 33144
L&C Professional Medical Research Institute
[Recruiting]
Miami, Florida, United States, 33144
Medical Research Center
[Recruiting]
Miami, Florida, United States, 33144
Medical Research Center
[Recruiting]
Miami, Florida, United States, 33144
Gastroenterology Group of Naples
[Recruiting]
Naples, Florida, United States, 34102
Gastroenterology Group of Naples
[Recruiting]
Naples, Florida, United States, 34102
Avail Clinical Research, LLC
[Recruiting]
Orange City, Florida, United States, 32763
Avail Clinical Research, LLC
[Recruiting]
Orange City, Florida, United States, 32763
Tampa General Hospital
[Recruiting]
Tampa, Florida, United States, 33606
Tampa General Hospital
[Recruiting]
Tampa, Florida, United States, 33606
Florida Medical Clinic, PA
[Recruiting]
Zephyrhills, Florida, United States, 33542
Florida Medical Clinic, PA
[Recruiting]
Zephyrhills, Florida, United States, 33542
United States, GeorgiaUnited States, Georgia
Gastroenterology Associates Of Central Georgia, LLC
[Recruiting]
Macon, Georgia, United States, 31201
Gastroenterology Associates Of Central Georgia, LLC
[Recruiting]
Macon, Georgia, United States, 31201
One Health Research Clinic, Inc
[Recruiting]
Norcross, Georgia, United States, 30093
One Health Research Clinic, Inc
[Recruiting]
Norcross, Georgia, United States, 30093
United States, IllinoisUnited States, Illinois
Northwestern University Feinberg School of Medicine
[Not yet recruiting]
Chicago, Illinois, United States, 60611
Northwestern University Feinberg School of Medicine
[Not yet recruiting]
Chicago, Illinois, United States, 60611
United States, IowaUnited States, Iowa
University of Iowa Hospitals and Clinics
[Recruiting]
Iowa City, Iowa, United States, 52242
University of Iowa Hospitals and Clinics
[Recruiting]
Iowa City, Iowa, United States, 52242
United States, LouisianaUnited States, Louisiana
Delta Research Partners
[Recruiting]
Monroe, Louisiana, United States, 71201
Delta Research Partners
[Recruiting]
Monroe, Louisiana, United States, 71201
Tulane University Health Sciences Center
[Recruiting]
New Orleans, Louisiana, United States, 70112
Tulane University Health Sciences Center
[Recruiting]
New Orleans, Louisiana, United States, 70112
Louisiana Research Center
[Recruiting]
Shreveport, Louisiana, United States, 71105
Louisiana Research Center
[Recruiting]
Shreveport, Louisiana, United States, 71105
United States, MarylandUnited States, Maryland
Investigative Clinical Research
[Recruiting]
Annapolis, Maryland, United States, 21401
Investigative Clinical Research
[Recruiting]
Annapolis, Maryland, United States, 21401
Gastro Center of Maryland
[Recruiting]
Columbia, Maryland, United States, 21045
Gastro Center of Maryland
[Recruiting]
Columbia, Maryland, United States, 21045
United States, MichiganUnited States, Michigan
Clinical Research Institute of Michigan, LLC
[Recruiting]
Chesterfield, Michigan, United States, 48047
Clinical Research Institute of Michigan, LLC
[Recruiting]
Chesterfield, Michigan, United States, 48047
United States, MissouriUnited States, Missouri
Washington University School of Medicine
[Recruiting]
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine
[Recruiting]
Saint Louis, Missouri, United States, 63110
United States, North DakotaUnited States, North Dakota
Fargo Gastroenterology and Hepatology Clinic
[Recruiting]
Fargo, North Dakota, United States, 58103
Fargo Gastroenterology and Hepatology Clinic
[Recruiting]
Fargo, North Dakota, United States, 58103
United States, OhioUnited States, Ohio
Dayton Gastroenterology, Inc
[Recruiting]
Beavercreek, Ohio, United States, 45440
Dayton Gastroenterology, Inc
[Recruiting]
Beavercreek, Ohio, United States, 45440
Consultants for Clinical Research
[Recruiting]
Cincinnati, Ohio, United States, 45219
Consultants for Clinical Research
[Recruiting]
Cincinnati, Ohio, United States, 45219
Great Lakes Gastroenterology Research, LLC
[Recruiting]
Mentor, Ohio, United States, 44060
Great Lakes Gastroenterology Research, LLC
[Recruiting]
Mentor, Ohio, United States, 44060
Paramount Medical Research & Consulting, LLC
[Recruiting]
Middleburg Heights, Ohio, United States, 44130
Paramount Medical Research & Consulting, LLC
[Recruiting]
Middleburg Heights, Ohio, United States, 44130
United States, Pennsylvania
Frontier Clinical Research, LLC
[Active, not recruiting]
Smithfield, Pennsylvania, United States, 15478
United States, Pennsylvania
Digestive Disease Associates, LTD
[Not yet recruiting]
Wyomissing, Pennsylvania, United States, 19610
Digestive Disease Associates, LTD
[Not yet recruiting]
Wyomissing, Pennsylvania, United States, 19610
United States, TennesseeUnited States, Tennessee
Gastro One
[Recruiting]
Germantown, Tennessee, United States, 38138
Gastro One
[Recruiting]
Germantown, Tennessee, United States, 38138
Vanderbilt University Medical Center-IBD Clinic
[Recruiting]
Nashville, Tennessee, United States, 37232
Vanderbilt University Medical Center-IBD Clinic
[Recruiting]
Nashville, Tennessee, United States, 37232
United States, TexasUnited States, Texas
Texas Clinical Research Institute
[Recruiting]
Arlington, Texas, United States, 76012
Texas Clinical Research Institute
[Recruiting]
Arlington, Texas, United States, 76012
Pinnacle Clinical Research
[Recruiting]
Austin, Texas, United States, 78745
Pinnacle Clinical Research
[Recruiting]
Austin, Texas, United States, 78745
The Methodist Hospital
[Recruiting]
Houston, Texas, United States, 77030
The Methodist Hospital
[Recruiting]
Houston, Texas, United States, 77030
University of Texas Health Science Center at Houston
[Recruiting]
Houston, Texas, United States, 77030
University of Texas Health Science Center at Houston
[Recruiting]
Houston, Texas, United States, 77030
Pinnacle Clinical Research
[Recruiting]
Live Oak, Texas, United States, 78233
Pinnacle Clinical Research
[Recruiting]
Live Oak, Texas, United States, 78233
DHAT Research Institute
[Recruiting]
Richardson, Texas, United States, 75082
DHAT Research Institute
[Recruiting]
Richardson, Texas, United States, 75082
Gastroenterology Research of San Antonio
[Recruiting]
San Antonio, Texas, United States, 78229
Gastroenterology Research of San Antonio
[Recruiting]
San Antonio, Texas, United States, 78229
Texas Digestive Disease Consultants
[Recruiting]
San Marcos, Texas, United States, 78130
Texas Digestive Disease Consultants
[Recruiting]
San Marcos, Texas, United States, 78130
Texas Digestive Disease Consultants
[Recruiting]
Southlake, Texas, United States, 76092
Texas Digestive Disease Consultants
[Recruiting]
Southlake, Texas, United States, 76092
Spring Gastroenterology
[Recruiting]
Spring, Texas, United States, 77386
Spring Gastroenterology
[Recruiting]
Spring, Texas, United States, 77386
United States, UtahUnited States, Utah
Val R. Hansen, M.D.
[Recruiting]
Bountiful, Utah, United States, 84010
Val R. Hansen, M.D.
[Recruiting]
Bountiful, Utah, United States, 84010
Clinical Research Advantage, Inc. / Wasatch Peak Family Practice
[Recruiting]
Layton, Utah, United States, 84041
Clinical Research Advantage, Inc. / Wasatch Peak Family Practice
[Recruiting]
Layton, Utah, United States, 84041
United States, VirginiaUnited States, Virginia
Gastroenterology Associates Of Tidewater
[Recruiting]
Chesapeake, Virginia, United States, 23320
Gastroenterology Associates Of Tidewater
[Recruiting]
Chesapeake, Virginia, United States, 23320
Emeritas Research Group
[Recruiting]
Lansdowne, Virginia, United States, 20176
Emeritas Research Group
[Withdrawn]
Lansdowne Town Center, Virginia, United States, 20176
McGuire DVAMC
[Recruiting]
Richmond, Virginia, United States, 23249
McGuire DVAMC
[Recruiting]
Richmond, Virginia, United States, 23249
Australia, VictoriaAustralia, Victoria
Monash Medical Centre
[Recruiting]
Clayton, Victoria, Australia, 3168
Monash Medical Centre
[Recruiting]
Clayton, Victoria, Australia, 3168
AustriaAustria
AKH Wien - Universitatsklinik fur Innere Medizin III
[Recruiting]
Vienna, Austria, 1090
AKH Wien - Universitatsklinik fur Innere Medizin III
[Recruiting]
Vienna, Austria, 1090
BelgiumBelgium
Algemeen Ziekenhuis Sint-Maarten
[Recruiting]
Mechelen, Belgium, 2800
Algemeen Ziekenhuis Sint-Maarten
[Recruiting]
Mechelen, Belgium, 2800
CanadaCanada
Discovery Clinical Services Ltd.
[Recruiting]
Victoria, Canada, V8T 5G4
Discovery Clinical Services Ltd.
[Recruiting]
Victoria, Canada, V8T 5G4
CzechiaCzechia
G.E.P Clinics, s r.o
[Recruiting]
Praha, Czechia, 130 00
G.E.P Clinics, s r.o
[Recruiting]
Praha, Czechia, 130 00
GermanyGermany
DRK Kliniken Berlin Westend
[Recruiting]
Berlin, Germany, 14050
DRK Kliniken Berlin Westend
[Recruiting]
Berlin, Germany, 14050
CED Studien UG, Internationales Crohn Colitis Centrum (ICCC) Rhein-Main
[Recruiting]
Frankfurt, Germany, 60954
CED Studien UG, Internationales Crohn Colitis Centrum (ICCC) Rhein-Main
[Recruiting]
Frankfurt, Germany, 60954
Medizinische Hochschule Hannover
[Recruiting]
Hannover, Germany, 30625
Medizinische Hochschule Hannover
[Recruiting]
Hannover, Germany, 30625
Universitatsklinikum Ulm
[Recruiting]
Ulm, Germany, 89081
Universitatsklinikum Ulm
[Recruiting]
Ulm, Germany, 89081
India, GujaratIndia, Gujarat
Surat Institute of Digestive Sciences
[Recruiting]
Surat, Gujarat, India, 395002
Surat Institute of Digestive Sciences
[Recruiting]
Surat, Gujarat, India, 395002
India, MumbaiIndia, Mumbai
Seth GS medical college and KEM hospital
[Recruiting]
Parel, Mumbai, India, 400012
Seth GS medical college and KEM hospital
[Recruiting]
Parel, Mumbai, India, 400012
IndiaIndia
Kaizen Hospital
[Recruiting]
Ahmedabad, India, 380052
Kaizen Hospital
[Recruiting]
Ahmedabad, India, 380052
Raj Jindal Super Speciality Hospital
[Recruiting]
Bharatpur, India, 321001
SP Medical college & AG Hospitals
[Recruiting]
Bīkaner, India, 334001
SP Medical college & AG Hospitals
[Recruiting]
Bīkaner, India, 334001
Apollo Specialty Hospital
[Recruiting]
Chennai, India, 600035
Apollo Specialty Hospital
[Recruiting]
Chennai, India, 600035
Maharaja Agrasen Hospital
[Recruiting]
Dehli, India, 110026
Maharaja Agrasen Hospital
[Recruiting]
Dehli, India, 110026
Fortis Memorial research Institute
[Recruiting]
Gurgaon, India, 122002
SR Kalla Memorial Gastro and General Hospital
[Recruiting]
Jaipur, India, 302001
SR Kalla Memorial Gastro and General Hospital
[Recruiting]
Jaipur, India, 302001
SMS Medical College and Hospital
[Recruiting]
Jaipur, India, 302004
SMS Medical College and Hospital
[Recruiting]
Jaipur, India, 302004
Institute of Post Graduate Medical Education and Research (IPGMER)
[Recruiting]
Kolkata, India, 700020
Institute of Post Graduate Medical Education and Research (IPGMER)
[Recruiting]
Kolkata, India, 700020
Radha Krishna Critical Care & General Hospital
[Active, not recruiting]
Kota, India, 324005
Dayanand Medical College & Hospital
[Recruiting]
Ludhiana, India, 141001
Dayanand Medical College & Hospital
[Recruiting]
Ludhiana, India, 141001
Apollo Speciality Hospital
[Recruiting]
Madurai, India, 625020
Apollo Speciality Hospital
[Recruiting]
Madurai, India, 625020
Kasturba Medical College (KCM) Hospital
[Recruiting]
Mangalore, India, 575001
Kasturba Medical College (KCM) Hospital
[Recruiting]
Mangalore, India, 575001
Rahate Surgical Hospital
[Recruiting]
Nagpur, India, 440008
Rahate Surgical Hospital
[Recruiting]
Nagpur, India, 440008
Crescent Hospital and Heart Centre
[Recruiting]
Nagpur, India, 440012
Crescent Hospital and Heart Centre
[Recruiting]
Nagpur, India, 440012
Sir Ganga Ram Hospital
[Recruiting]
New Delhi, India, 110060
Sir Ganga Ram Hospital
[Recruiting]
New Delhi, India, 110060
Batra Hospital and Medical Research Center
[Recruiting]
New Delhi, India, 110062
Batra Hospital and Medical Research Center
[Recruiting]
New Delhi, India, 110062
Grant Medical Foundation Ruby Hall Clinic
[Recruiting]
Pune, India, 411001
Grant Medical Foundation Ruby Hall Clinic
[Recruiting]
Pune, India, 411001
MTES'S Sanjeevan Hospital
[Recruiting]
Pune, India, 411004
MTES'S Sanjeevan Hospital
[Recruiting]
Pune, India, 411004
Niramaya Hospital
[Recruiting]
Pune, India, 411019
Niramaya Hospital
[Recruiting]
Pune, India, 411019
Shri Griraj Multispeciality Hospital
[Recruiting]
Rajkot, India, 360002
Shri Griraj Multispeciality Hospital
[Recruiting]
Rajkot, India, 360002
Gandhi Hospital
[Recruiting]
Secunderabad, India, 500003
Gandhi Hospital
[Recruiting]
Secunderabad, India, 500003
Institute of Gastroenterology & Liver Disease, Sunshine Hospitals
[Recruiting]
Secunderabad, India, 50003
Institute of Gastroenterology & Liver Disease, Sunshine Hospitals
[Recruiting]
Secunderabad, India, 50003
Kasturba Medical College Hospital
[Recruiting]
Udupi, India, 576104
Kasturba Medical College Hospital
[Recruiting]
Udupi, India, 576104
Sterling Hospital
[Recruiting]
Vadodara, India, 390007
Sterling Hospital
[Recruiting]
Vadodara, India, 390007
Samvedana Hospital
[Recruiting]
Varanasi, India, 221005
Samvedana Hospital
[Recruiting]
Varanasi, India, 221005
NetherlandsNetherlands
Nij Smellinghe Ziekenhuis
[Recruiting]
Drachten, Netherlands, 9202 NN
Nij Smellinghe Ziekenhuis
[Recruiting]
Drachten, Netherlands, 9202 NN
New ZealandNew Zealand
Wellington Hospital
[Recruiting]
Newtown, New Zealand, 6021
Wellington Hospital
[Recruiting]
Newtown, New Zealand, 6021
Poland, MazowieckiePoland, Mazowieckie
Medical concierge centrum medyczne
[Recruiting]
Warszawa, Mazowieckie, Poland, 02-798
Medical concierge centrum medyczne
[Recruiting]
Warszawa, Mazowieckie, Poland, 02-798
PolandPoland
Osrodek Badan Klinicznych Cinsante S.C Ewa Galczak-Nowak
[Recruiting]
Bydgoszcz, Poland, 85-079
Osrodek Badan Klinicznych Cinsante S.C Ewa Galczak-Nowak
[Recruiting]
Bydgoszcz, Poland, 85-079
NZOZ Inter-Med
[Recruiting]
Czestochowa, Poland, 42-217
NZOZ Inter-Med
[Recruiting]
Czestochowa, Poland, 42-217
Krakowskie Centrum Medyczne
[Recruiting]
Kraków, Poland, 31-501
Krakowskie Centrum Medyczne
[Recruiting]
Kraków, Poland, 31-501
Clinical Research Center Spolka z ograniczone odpowiedzialnocia Medic-R Spolka Komandytowa
[Recruiting]
Poznan, Poland, 60-856
Clinical Research Center Spolka z ograniczone odpowiedzialnocia Medic-R Spolka Komandytowa
[Recruiting]
Poznan, Poland, 60-856
Endoskopia Sp.z o.o
[Recruiting]
Sopot, Poland, 81-756
Endoskopia Sp.z o.o
[Recruiting]
Sopot, Poland, 81-756
Twoja Przychodnia Szczecinskie Centrum Medyczne
[Recruiting]
Szczecin, Poland, 70-361
Twoja Przychodnia Szczecinskie Centrum Medyczne
[Recruiting]
Szczecin, Poland, 70-361
H-T Centrum Medyczne - Endoterapia
[Recruiting]
Tychy, Poland, 43-100
H-T Centrum Medyczne - Endoterapia
[Recruiting]
Tychy, Poland, 43-100
Centrum Zdrowia MDM
[Recruiting]
Warszawa, Poland, 00-632
Centrum Zdrowia MDM
[Recruiting]
Warszawa, Poland, 00-632
Centrum Badawcze Wspolczesnej Terapii, Prywatny Gabinet Lekarski Dr Anna Bochenek-Mularczyk
[Recruiting]
Warszawa, Poland, 02-679
Centrum Badawcze Wspolczesnej Terapii, Prywatny Gabinet Lekarski Dr Anna Bochenek-Mularczyk
[Recruiting]
Warszawa, Poland, 02-679
Niepubliczny Zaklad Opieka Zdrowotnej VIVAMED Jadwiga Miecz
[Recruiting]
Warszawa, Poland, 03-580
Niepubliczny Zaklad Opieka Zdrowotnej VIVAMED Jadwiga Miecz
[Recruiting]
Warszawa, Poland, 03-580
Centrum Medyczne- Omni Clinic Sp. z o.o. Sp.k.
[Recruiting]
Wroclaw, Poland, 50-449
Centrum Medyczne- Omni Clinic Sp. z o.o. Sp.k.
[Recruiting]
Wroclaw, Poland, 50-449
Santa Familia, Centrum Badan Profilaktyki i Leczenia
[Recruiting]
Łódź, Poland, 90-302
Santa Familia, Centrum Badan Profilaktyki i Leczenia
[Recruiting]
Łódź, Poland, 90-302
PortugalPortugal
Hospital Lusiadas Lisboa
[Recruiting]
Lisboa, Portugal, 1500-458
Hospital Lusiadas Lisboa
[Recruiting]
Lisboa, Portugal, 1500-458
Unidade Local de Saude do Alto Minho, EPE
[Recruiting]
Viana do Castelo, Portugal, 4904-858
Unidade Local de Saude do Alto Minho, EPE
[Recruiting]
Viana do Castelo, Portugal, 4904-858
RomaniaRomania
Spitalul Universitar de Urgenta Bucuresti- Sectia Medicina Interna II
[Recruiting]
Bucharest, Romania, 50098
Spitalul Universitar de Urgenta Bucuresti- Sectia Medicina Interna II
[Recruiting]
Bucharest, Romania, 50098
Medlife - Policlinica de Diagnostic Rapid
[Recruiting]
Bucuresti, Romania, 10719
Medlife - Policlinica de Diagnostic Rapid
[Recruiting]
Bucuresti, Romania, 10719
S.C. Policlinica Dr. Citu S.R.L - Gastroenterologie
[Recruiting]
Timisoara, Romania, 300594
S.C. Policlinica Dr. Citu S.R.L - Gastroenterologie
[Recruiting]
Timisoara, Romania, 300594
Russian FederationRussian Federation
State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Hospital"
[Recruiting]
Chelyabinsk, Russian Federation, 454076
State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Hospital"
[Recruiting]
Chelyabinsk, Russian Federation, 454076
Federal State Budgetary Healthcare Institution Hospital Irkutsk Scientific Center of the Siberian Branch of the Russian Academy of Sciences
[Recruiting]
Irkutsk, Russian Federation, 664079
Federal State Budgetary Healthcare Institution Hospital Irkutsk Scientific Center of the Siberian Branch of the Russian Academy of Sciences
[Recruiting]
Irkutsk, Russian Federation, 664079
Olla-Med, Llc
[Recruiting]
Moscow, Russian Federation, 105554
Olla-Med, Llc
[Recruiting]
Moscow, Russian Federation, 105554
State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"
[Recruiting]
Moscow, Russian Federation, 127015
State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"
[Recruiting]
Moscow, Russian Federation, 127015
Municipal Budgetary Healthcare Institution "Clinical Diagnostics Centre "Zdorovye" in Rostov-on-Don"
[Recruiting]
Rostov-on-Don, Russian Federation, 344011
Municipal Budgetary Healthcare Institution "Clinical Diagnostics Centre "Zdorovye" in Rostov-on-Don"
[Recruiting]
Rostov-on-Don, Russian Federation, 344011
State Budgetary Educational Institution of Higher Professional Education "Rostov State Medical University" of the Ministry of Health of Russian Fedn.
[Recruiting]
Rostov-on-Don, Russian Federation, 344022
State Budgetary Educational Institution of Higher Professional Education "Rostov State Medical University" of the Ministry of Health of Russian Fedn.
[Recruiting]
Rostov-on-Don, Russian Federation, 344022
Saint Petersburg State Budgetary Healthcare Institution "City Hospital # 26"
[Recruiting]
Saint Petersburg, Russian Federation, 196247
Saint Petersburg State Budgetary Healthcare Institution "City Hospital # 26"
[Recruiting]
Saint Petersburg, Russian Federation, 196247
Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC
[Recruiting]
Smolensk, Russian Federation, 214019
Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC
[Recruiting]
Smolensk, Russian Federation, 214019
Saint Petersburg State Budgetary Healthcare Institution "City Hospital of the Holy Martyr Elizabeth"
[Recruiting]
St. Petersburg, Russian Federation, 195257
Saint Petersburg State Budgetary Healthcare Institution "City Hospital of the Holy Martyr Elizabeth"
[Recruiting]
St. Petersburg, Russian Federation, 195257
Spain
Hospital Universitario de Gran Canaria "Dr. Negrin"
[Recruiting]
Las Palmas De Gran Canaria, Spain, 35020
Spain
Hospital Universitario Virgen del Rocio
[Recruiting]
Sevilla, Spain, 41013
Hospital Universitario Virgen del Rocio
[Recruiting]
Sevilla, Spain, 41013
SwedenSweden
Akademiska Sjukhuset
[Recruiting]
Uppsala, Sweden, 75185
Akademiska Sjukhuset
[Recruiting]
Uppsala, Sweden, 75185
Taiwan
Changhua Christian Hospital
[Active, not recruiting]
Changhua, Taiwan, 500
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
[Active, not recruiting]
Kaohsiung, Taiwan, 807
Kaohsiung Medical University Chung-Ho Memorial Hospital
[Active, not recruiting]
Kaohsiung, Taiwan, 807
Tri-Service General Hospital
[Active, not recruiting]
Taipei, Taiwan, 114
UkraineUkraine
Municipal City Clinical Hospital of the Emergency Medical Care, 1st Therapeutics Department, Danylo Halytsky Lviv National Medical
[Recruiting]
Chernivtsi, Ukraine, 58000
Municipal City Clinical Hospital of the Emergency Medical Care, 1st Therapeutics Department, Danylo Halytsky Lviv National Medical
[Recruiting]
Chernivtsi, Ukraine, 58000
Kharkiv Medical Academy of Post-graduate Education of MOH of Ukraine
[Recruiting]
Kharkiv, Ukraine, 61137
Kharkiv Medical Academy of Post-graduate Education of MOH of Ukraine
[Recruiting]
Kharkiv, Ukraine, 61137
Kyiv City Clinical Hospital #18, Proctology Department
[Recruiting]
Kiev, Ukraine, 01030
Kyiv City Clinical Hospital #18, Proctology Department
[Recruiting]
Kiev, Ukraine, 01030
Ternopil University Hospital, Regional Centre of Gastroenterology with Hepatology
[Recruiting]
Ternopil, Ukraine, 46001
Ternopil University Hospital, Regional Centre of Gastroenterology with Hepatology
[Recruiting]
Ternopil, Ukraine, 46001
Municipal Institution "Uzhgorod District Hospital", Therapeutics Department
[Recruiting]
Uzhgorod, Ukraine, 88000
Municipal Institution "Uzhgorod District Hospital", Therapeutics Department
[Recruiting]
Uzhgorod, Ukraine, 88000
Municipal Healthcare Institution-Kharkiv City Clinical Hospital #2
[Recruiting]
Uzhgorod, Ukraine, 88009
Municipal Healthcare Institution-Kharkiv City Clinical Hospital #2
[Recruiting]
Uzhgorod, Ukraine, 88009
Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No. 2
[Recruiting]
Vinnitsa, Ukraine, 21018
Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No. 2
[Recruiting]
Vinnitsa, Ukraine, 21018
Vinnytsia Regional Clinical Hospital named after M.I. Pirogov, Gastroenterology Department
[Recruiting]
Vinnitsya, Ukraine, 21018
Vinnytsia Regional Clinical Hospital named after M.I. Pirogov, Gastroenterology Department
[Recruiting]
Vinnitsya, Ukraine, 21018
Medical Center LLC "Health Clinic", Medical Clinical Investigational Center
[Recruiting]
Vinnitsya, Ukraine, 21029
Medical Center LLC "Health Clinic", Medical Clinical Investigational Center
[Recruiting]
Vinnitsya, Ukraine, 21029
Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No.1
[Recruiting]
Vinnytsya, Ukraine, 21018
Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No.1
[Recruiting]
Vinnytsya, Ukraine, 21018
Municupal Institution "Zaporizhzhia City Multidisciplinary Clinic #9" Gastrointestinal Surgery Department,
[Recruiting]
Zaporizhzhya, Ukraine, 69096
Municupal Institution "Zaporizhzhia City Multidisciplinary Clinic #9" Gastrointestinal Surgery Department,
[Recruiting]
Zaporizhzhya, Ukraine, 69096
Municipal Institution "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council, Regional Center of Diagnostics,
[Recruiting]
Zaporizhzhya, Ukraine, 69600
Municipal Institution "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council, Regional Center of Diagnostics,
[Recruiting]
Zaporizhzhya, Ukraine, 69600
United KingdomUnited Kingdom
Blackpool Teaching hospitals NHS Trust
[Recruiting]
Blackpool, United Kingdom, FY3 8NR
Blackpool Teaching hospitals NHS Trust
[Recruiting]
Blackpool, United Kingdom, FY3 8NR
Cambridge University Hospitals NHS Foundation Trust
[Recruiting]
Cambridge, United Kingdom, CB2 0QQ
Royal Devon and Exeter NHS Foundation Trust
[Recruiting]
Exeter, United Kingdom, EX2 5DW
Royal Devon and Exeter NHS Foundation Trust
[Recruiting]
Exeter, United Kingdom, EX2 5DW
IPDSharing
Plan to Share IPD:
References
Citations:
Links:
Available IPD/Information:

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