A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
Public ClinicalTrials.gov record NCT02641392. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study. The GED-0301-CD-003 trial was not initiated; see detailed description.
Study identification
- NCT ID
- NCT02641392
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 310 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 25, 2016 (Actual)
- Primary completion
- Jan 4, 2018 (Actual)
- Completion
- Jan 4, 2018 (Actual)
- Last update posted
- Jan 29, 2019
2016 – 2018
United States locations
- U.S. sites
- 23
- U.S. states
- 13
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical Associates Research Group Inc. | San Diego | California | 902123 | — |
| Atlanta Gastroenterology Associates, LLC | Atlanta | Georgia | 30342 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Health Science Research Center, LLC | Pratt | Kansas | 67124 | — |
| Via Christi Research a division of Via Christi Hospitals Wichita Inc | Wichita | Kansas | 67208 | — |
| Gastroenterology Associates LLC | Baton Rouge | Louisiana | 70809 | — |
| Metropolitan Gastroenterology | Chevy Chase | Maryland | 20815 | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | — |
| Gastroenterology Associates of Western Michigan PLC | Wyoming | Michigan | 49519 | — |
| Ehrhardt Clinical Research LLC | Belton | Missouri | 64012 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Trial Management Associates LLC | Wilmington | North Carolina | 28401 | — |
| ClinSearch LLC | Chattanooga | Tennessee | 37421 | — |
| Texas Clinical Research Institute LLC | Arlington | Texas | 76012 | — |
| Texas Digestive Disease Consultants - Dallas | Dallas | Texas | 75231 | — |
| Texas Digestive Disease Consultants - Southlake | Flower Mound | Texas | 75028 | — |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| Sagact Pllc | San Antonio | Texas | 78229 | — |
| San Antonio Military Medical Center | San Antonio | Texas | 78229 | — |
| Digestive Health Specialists of Tyler | Tyler | Texas | 75701 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
| University of Washington School of Medicine | Seattle | Washington | 98104 | — |
| The Vancouver Clinic | Vancouver | Washington | 98664-4896 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 208 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02641392, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 29, 2019 · Synced Oct 28, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02641392 live on ClinicalTrials.gov.