ClinicalTrials.gov record
Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
ClinicalTrials.gov ID: NCT04365868
Public ClinicalTrials.gov record NCT04365868. 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 Seamless, Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients with nonalcoholic steatohepatitis (NASH) cirrhosis and clinical signs of portal hypertension but without esophageal varices at baseline.
Study identification
- NCT ID
- NCT04365868
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 357 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- 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
- Jun 25, 2020 (Actual)
- Primary completion
- Mar 11, 2025 (Actual)
- Completion
- Apr 10, 2025 (Actual)
- Last update posted
- Jun 30, 2026
2020 – 2025
United States locations
- U.S. sites
- 81
- U.S. states
- 28
- U.S. cities
- 72
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Digestive Health Specialists | Dothan | Alabama | 36305 | — |
| The Institute for Liver Health | Chandler | Arizona | 85224 | — |
| Arizona Liver Health - Glendale | Glendale | Arizona | 85306 | — |
| Institute for Liver Health - Tucson | Tucson | Arizona | 85712 | — |
| Liver Wellness Center - Little Rock | Little Rock | Arkansas | 72205-6414 | — |
| Hope Clinical Research, Inc. | Canoga Park | California | 91303 | — |
| Southern California GI & Liver Centers | Coronado | California | 92118 | — |
| University of California San Diego Medical Center -La Jolla Multi-Specialty Clinics- Perlman Offices | La Jolla | California | 92037 | — |
| Om Research LLC | Lancaster | California | 93534 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| inSite Digestive Health Care - Orange | Orange | California | 92868 | — |
| California Liver Research Institute | Pasadena | California | 91105 | — |
| Inland Empire Liver Foundation | Rialto | California | 92377 | — |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907-6262 | — |
| Integrity Clinical Research, LLC (ICR SITES) - Doral | Doral | Florida | 33166 | — |
| Nature Coast Clinical Research, LLC | Inverness | Florida | 34452 | — |
| Mayo Clinic Hospital - Florida | Jacksonville | Florida | 32224-1865 | — |
| Florida Research Institute | Lakewood Rch | Florida | 34211 | — |
| ClinCloud LLC | Maitland | Florida | 32751-3320 | — |
| Advanced Pharma CR, LLC | Miami | Florida | 33147 | — |
| Genoma Research Group, Inc. | Miami | Florida | 33165 | — |
| Sensible Healthcare | Ocoee | Florida | 34761 | — |
| Guardian Angel Health Services, Inc. | Tampa | Florida | 33614 | — |
| Florida Medical Center & Research | Zephyrhills | Florida | 33542 | — |
| Digestive Healthcare of Georgia, P.C. | Atlanta | Georgia | 30309 | — |
| Gastroenterology Associates of Central Georgia, LLC | Macon | Georgia | 31201 | — |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | — |
| Loyola University Health System | Maywood | Illinois | 60153 | — |
| IU Health University Hospital | Indianapolis | Indiana | 46202 | — |
| Michiana Gastroenterology, Inc. | South Bend | Indiana | 46635 | — |
| Kansas Medical Clinic PA | Topeka | Kansas | 66606 | — |
| University of Louisville Physicians - Cardiovascular Medicine Physicians Outpatient Center | Louisville | Kentucky | 40202-2046 | — |
| Tandem Clinical Research, LLC | Marrero | Louisiana | 70072 | — |
| Tulane Cancer Center | New Orleans | Louisiana | 70112-2600 | — |
| Mercy Medical Center - The Institute for Digestive Health and Liver Disease | Baltimore | Maryland | 21202 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111-1552 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Health System - Hemophilia and Thrombosis Treatment Center | Detroit | Michigan | 48202 | — |
| Gastroenterology Associates of Western Michigan | Wyoming | Michigan | 49519 | — |
| Southern Therapy and Advanced Research (STAR) - Jackson | Jackson | Mississippi | 39216 | — |
| Kansas City Research Institute | Kansas City | Missouri | 64131 | — |
| Excel Clinical Research - Las Vegas | Las Vegas | Nevada | 89109-6209 | — |
| Mount Sinai Beth Israel | New York | New York | 10003 | — |
| NYU Langone Medical Center | New York | New York | 10016-6402 | — |
| NewYork-Presbyterian Hospital/Weill Cornell Medical Center | New York | New York | 10021 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| UNC-Chapel Hill School of Medicine | Chapel Hill | North Carolina | 273302 | — |
| Cumberland Research Associates, LLC | Fayetteville | North Carolina | 28304-3571 | — |
| Lucas Research | Morehead City | North Carolina | 28557 | — |
| Consultants for Clinical Research | Cincinnati | Ohio | 45249 | — |
| University of Cincinnati Physicians Company, LLC | Cincinnati | Ohio | 45267-0595 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44016 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| The Jefferson Digestive Health Institute - Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases | Pittsburgh | Pennsylvania | 15213 | — |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | — |
| Galen Medical Group - Ziegler Plaza | Chattanooga | Tennessee | 37343-5470 | — |
| University Diabetes & Endocrine Consultants | Chattanooga | Tennessee | 37411 | — |
| Gastro One - GI Diagnostic and Therapeutic Endoscopy Center - 1310 Wolf Park | Germantown | Tennessee | 38138 | — |
| Associates in Gastroenterology | Hermitage | Tennessee | 37067 | — |
| East Tennessee Research Institute - Gastrointestinal Associates of Northeast Tennessee, P.C. | Johnson City | Tennessee | 37604-6063 | — |
| Texas Clinical Research Institute, LLC | Arlington | Texas | 76012 | — |
| Liver Specialists of Texas | Austin | Texas | 78757 | — |
| Methodist Transplant Physicians | Dallas | Texas | 75203 | — |
| Texoma Liver Center PLLC. - Denison | Denison | Texas | 75020 | — |
| South Texas Research Institute | Edinburg | Texas | 78539 | — |
| Baylor College of Medicine - Baylor Clinic - Abdominal Transplant & Liver Disease Clinic | Houston | Texas | 77030 | — |
| Pioneer Research Solutions Inc - Houston - Stancliff Rd | Houston | Texas | 77099 | — |
| The Texas Liver Institute, Inc. | San Antonio | Texas | 78215 | — |
| Pinnacle Clinical Research | San Antonio | Texas | 78229 | — |
| Impact Research Institute | Waco | Texas | 76710-2582 | — |
| University of Utah Health Care - UUHC - Kidney & Liver Clinic | Salt Lake City | Utah | 84132-0001 | — |
| University of Virginia School of Medicine | Charlottesville | Virginia | 22908 | — |
| Gastroenterology Associates of Fredericksburg | Fredericksburg | Virginia | 22401-8425 | — |
| Bon Secours Liver Institute of Virginia - Newport News | Newport News | Virginia | 23602 | — |
| Bon Secours Liver Institute of Virginia - Richmond | Richmond | Virginia | 23226 | — |
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249-0001 | — |
| Velocity Clinical Research, Spokane | Spokane | Washington | 99202-3462 | — |
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 75 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04365868, 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 Jun 30, 2026 · Synced Oct 22, 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 NCT04365868 live on ClinicalTrials.gov.