Gastroenterology & Hepatology clinical trial failures

Phase II Clinical Stage II Esophageal Adenocarcinoma AJCC v8 trial by National Cancer Institute (NCI). Stop reason: OTHER/UNKNOWN.

End of Initial Phase of Multi-phase protocol

Phase II Angioimmunoblastic T-cell Lymphoma trial by Alliance for Clinical Trials in Oncology. Stop reason: EFFICACY/FUTILITY.

Interim Analysis

Phase IV Liver Transplant Failure and Rejection trial by University of Wisconsin, Madison. Stop reason: OTHER/UNKNOWN.

Resources

Phase II Crohn's Disease trial by Pfizer. Stop reason: EFFICACY/FUTILITY.

The study was prematurely discontinued due to a lack of efficacy in sub-study 1

Phase II Prevention of Esophageal Varices trial by Galectin Therapeutics Inc.. Stop reason: REGULATORY.

Based on FDA feedback, Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was not prematurely terminated for safety reasons.

Phase II Liver and Intrahepatic Bile Duct Carcinoma trial by OHSU Knight Cancer Institute. Stop reason: OTHER/UNKNOWN.

change in standard-of-care systemic therapy

Phase II Hepatocellular Carcinoma trial by Assistance Publique - Hôpitaux de Paris. Stop reason: OPERATIONAL.

Because patient recruitment was affected by the COVID-19 pandemic, the study sponsor and funding partner halted enrollment at that time to meet contractual obligations

Phase II Ulcerative Colitis trial by AstraZeneca. Stop reason: OPERATIONAL.

Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.

Phase II Ulcerative Colitis trial by AstraZeneca. Stop reason: OPERATIONAL.

Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.

Phase I Healthy Adult Volunteers trial by NIBEC Co., Ltd.. Stop reason: OPERATIONAL.

Study was terminated at the end of Part A for strategic reasons (not due to lack of efficacy or safety issues

Phase II Crohn Disease trial by Mayo Clinic. Stop reason: OPERATIONAL.

Sponsor discontinued placebo. Unable to meet enrollment goals.

Phase II Hepatocellular Carcinoma trial by University of Texas Southwestern Medical Center. Stop reason: OPERATIONAL.

The decision was made to close the study to enrollment due to poor overall accrual and the inability to meet the 31% overall enrollment goal.

Phase IV Clostridia Difficile Colitis trial by Ohio State University. Stop reason: OPERATIONAL.

Difficulties with enrollment and inability to guarantee further study drug supply after current supply expired.

Unknown Moderate to Severe Ulcerative Colitis trial by University Hospital, Clermont-Ferrand. Stop reason: OTHER/UNKNOWN.

We were able to test our hypothesis using the current data

Phase I Hepatitis B trial by GlaxoSmithKline. Stop reason: OPERATIONAL.

The study was terminated as a strategic decision

Phase II Ulcerative Colitis trial by AbbVie. Stop reason: OPERATIONAL.

Sponsor Decision\_Not Safety Related

Phase II Unresectable Hepatocellular Carcinoma trial by University of Miami. Stop reason: OPERATIONAL.

Investigator decision

Phase II Pancreatic Neuroendocrine Tumor trial by Changhai Hospital. Stop reason: OPERATIONAL.

This investigator-initiated study closed to recruitment early due to slower-than-anticipated patient accrual.

Early Phase I Bariatric Surgery Candidate trial by McMaster University. Stop reason: OPERATIONAL.

No funding available.

Phase III Acute-On-Chronic Liver Failure trial by Instituto Grifols, S.A.. Stop reason: OPERATIONAL.

Due to corporate business reasons only (non-safety related decision)

Phase IV Ulcerative Colitis trial by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa. Stop reason: OPERATIONAL.

slow recruitment rate

Early Phase I Exocrine Pancreatic Cancer trial by University of Oklahoma. Stop reason: OTHER/UNKNOWN.

Translational scientist left university

Phase II Adebrelimab trial by Tianjin Medical University Cancer Institute and Hospital. Stop reason: OPERATIONAL.

Mid-term data analysis for the project has been completed; enrollment is now suspended.

Phase III GERD (Gastroesophageal Reflux Disease) trial by Cinclus Pharma Holding AB. Stop reason: OTHER/UNKNOWN.

Strategic desicion by Sponsor

Phase IV Vaginal Laceration During Delivery trial by Montefiore Medical Center. Stop reason: OPERATIONAL.

Difficulty with enrollment

Phase II Cholangiocarcinoma trial by Lisata Therapeutics, Inc.. Stop reason: OTHER/UNKNOWN.

The study was halted prematurely to allow analysis of the results.

Unknown Hepatitis C trial by Kirby Institute. Stop reason: OPERATIONAL.

The study was impacted by the COVID-19 pandemic. Once recruitment recommenced it remained slow. Removal of Sofosbuvir from the PBS November 2020 impacted recruitment into Cohort B. Study closed early on 15-Sep-26.

Early Phase I Pancreatic Ductal Adenocarcinoma trial by M.D. Anderson Cancer Center. Stop reason: OPERATIONAL.

PI request

Phase I Gastrointestinal Cancer trial by National Cancer Institute (NCI). Stop reason: OPERATIONAL.

Study was closed due to lack of accrual and study outcomes overlapped with another protocol's eligibility.

Phase II Pancreatic Cancer trial by Rutgers, The State University of New Jersey. Stop reason: OPERATIONAL.

No patients enrolled

Phase IV Liver Transplant Surgery trial by Ezeldeen Abuelkasem. Stop reason: OTHER/UNKNOWN.

No supply of the test substance was provided by the sponsor.

Phase II Hepatocellular Carcinoma trial by University of Cincinnati. Stop reason: OPERATIONAL.

The study is closing due to low enrollment and feasibility of the study.

Phase II Alcohol Associated Hepatitis trial by Intercept Pharmaceuticals. Stop reason: OPERATIONAL.

Intercept made the business decision to terminate the study on 31 Mar 2026 as there was no clear evidence of potential benefit of INT-787 in sAH. This decision was not based on a safety concern.

Phase II Borderline Resectable Pancreatic Adenocarcinoma trial by M.D. Anderson Cancer Center. Stop reason: OTHER/UNKNOWN.

0 participants

Phase I Advanced Gastrointestinal Tumors trial by Suzhou Zelgen Biopharmaceuticals Co.,Ltd. Stop reason: OTHER/UNKNOWN.

Due to R\&D strategy adjustments; no safety issues involved.

Unknown Liver Cancer trial by RenJi Hospital. Stop reason: OTHER/UNKNOWN.

The study was terminated because the originally planned VIC-1911 dose-escalation scheme (100 mg, 150 mg, 200 mg BID) was scientifically unjustified, lacking prior clinical safety data to support such starting doses when combined with lenvatinib in HC

Phase II Colitis, Ulcerative trial by Oppilan Pharma Ltd. Stop reason: OTHER/UNKNOWN.

The Induction and Long-Term Extension Periods were completed and analyzed as planned. The Sponsor decided to terminate clinical conduct in the Open-Label Extension Period. The decision to terminate the study was not due to safety concerns.

Phase III Hepatectomy trial by University Hospital, Rouen. Stop reason: OPERATIONAL.

End of enrollment period, difficulty enrolling patients

Phase II Recurrent Hepatocellular Carcinoma trial by Emory University. Stop reason: OPERATIONAL.

Slow Accrual

Phase I Ileal Pouch trial by Anthony Lembo. Stop reason: OPERATIONAL.

PI left Cleveland Clinic

Phase I Ulcerative Colitis trial by The Cleveland Clinic. Stop reason: OPERATIONAL.

PI left Cleveland Clinic

Phase I Crohn Colitis trial by The Cleveland Clinic. Stop reason: OPERATIONAL.

PI left Cleveland Clinic

Phase I Perianal Fistula Due to Crohn's Disease (Disorder) trial by Anthony Lembo. Stop reason: OPERATIONAL.

PI left institution

Phase IV Hepatitis B trial by Rockefeller University. Stop reason: OTHER/UNKNOWN.

The yield of cells recovered from the lymph node fine needle aspirations was low limiting the ability to perform the planned immunologic assessments following HBV vaccination.

Phase I Hepatic Impairment trial by Epizyme, Inc.. Stop reason: OTHER/UNKNOWN.

Ipsen decided to discontinue all active tazemetostat clinical trials.

Phase I Rectovaginal Fistula trial by Anthony Lembo. Stop reason: OPERATIONAL.

PI left Cleveland Clinic

Phase I Pouchitis trial by The Cleveland Clinic. Stop reason: OPERATIONAL.

PI decision not to move forward with study.

Phase I Perianal Crohn Disease trial by Anthony Lembo. Stop reason: OPERATIONAL.

PI left Cleveland Clinic

Phase I Gastric and Gastroesophageal Junction Carcinoma trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

Study was closed early as the sponsor decided not to continue development of certain treatment combinations.

Phase I Crohn's Disease trial by The Cleveland Clinic. Stop reason: OTHER/UNKNOWN.

This clinical trial was entered in error. Please refer to the correct entry of this study using the following link: https://clinicaltrials.gov/ct2/show/NCT04519684

Phase I Hepatocellular Carcinoma trial by T-ACE Medical Co., Ltd. Stop reason: REGULATORY.

The study was suspended in Taiwan following regulatory authority decision. The overall study under U.S. IND remains active.

Unknown Growth Failure trial by University of California, Los Angeles. Stop reason: OPERATIONAL.

The sponsor has notified us that they are not funding the study

Phase II Pancreatic Cancer trial by Cancer Trials Ireland. Stop reason: EFFICACY/FUTILITY.

Study terminated due to futility

Phase II Gastric Adenocarcinoma trial by Baylor College of Medicine. Stop reason: OPERATIONAL.

Since activation, 3 subjects were enrolled but were ineligible for randomization to a treatment arm because of a positive diagnostic laparoscopy result. Given the repeat inability to enroll and randomize an eligible subject; accrual was halted.

Phase II Oral Mucositis trial by Instituto Nacional de Cancer, Brazil. Stop reason: OTHER/UNKNOWN.

The study was terminated due to difficulties in including patients because of the slow rate at which patients met the established treatment profile at the proposing institution.

Phase II Pancreatic Diseases trial by Mayo Clinic. Stop reason: EFFICACY/FUTILITY.

study paused for interim analysis

Phase II Lymphoma trial by Eric Jacobsen, MD. Stop reason: SAFETY.

Ipsen requested a temporary closure due to a safety concern.

Phase II Carcinoma, Hepatocellular trial by University Hospital, Montpellier. Stop reason: OPERATIONAL.

Enrollement rythm low, funding body decision.

Phase III Pancreatic Cyst trial by Milton S. Hershey Medical Center. Stop reason: OTHER/UNKNOWN.

Grant ended

Phase IV Hemorrhage trial by Assistance Publique - Hôpitaux de Paris. Stop reason: EFFICACY/FUTILITY.

reason of halt prematurely: futility of the trial

Phase II Gastroparesis trial by CinDome Pharma, Inc.. Stop reason: OPERATIONAL.

Terminated based on Sponsor decision due to lot recall of GEBT kits impacting the primary endpoint evaluation for Dose 2 and Dose 3.

Phase II Crohn Disease trial by Children's Hospital Medical Center, Cincinnati. Stop reason: OTHER/UNKNOWN.

This was the Pilot study. The larger, confirmatory study has started

Phase II Pancreatic Acinar Cell Carcinoma trial by National Cancer Institute (NCI). Stop reason: OPERATIONAL.

The study was terminated due to low accrual and insufficient efficacy seen in first few participants treated.

Phase II Ulcerative Colitis trial by Stanford University. Stop reason: OPERATIONAL.

Lack of recruitment and funding.

Phase III Carcinoma, Hepatocellular trial by Translational Research in Oncology. Stop reason: OPERATIONAL.

The trial ended earlier than planned due to slow enrolment, which has made it unfeasible to achieve the target sample size within a reasonable timeframe. Consequently, a business decision has been made to discontinue funding for the trial.

Phase II Hepatocellular Carcinoma trial by Wake Forest University Health Sciences. Stop reason: OPERATIONAL.

Slow accruals

Phase I Ulcerative Colitis trial by Pfizer. Stop reason: OPERATIONAL.

The study was terminated due to business decision. The decision to terminate the trial was not based on any safety concerns associated with PF-07054894.

Phase II Ulcerative Colitis trial by Genentech, Inc.. Stop reason: EFFICACY/FUTILITY.

Based on a futility analysis, which suggested that the Moonglow study was unlikely to meet its primary endpoint.

Phase IV Crohn Disease trial by Cedars-Sinai Medical Center. Stop reason: OPERATIONAL.

Recruitment challenges; changes in manufacturing

Phase II Hepatocellular Carcinoma trial by National Cancer Institute (NCI). Stop reason: OPERATIONAL.

Study was terminated due to poor accrual.

Phase I Hepatitis B, Chronic trial by GlaxoSmithKline. Stop reason: EFFICACY/FUTILITY.

Following the primary phase (24 weeks post last vaccination) the predefined efficacy endpoint was not met. Noting the lack of efficacy and with the objective to prioritize participants' safety GSK has decided on the early termination of the study.

Phase I Hepato Cellular Carcinoma (HCC) trial by Case Comprehensive Cancer Center. Stop reason: OPERATIONAL.

Funding unavailable

Phase II Hepatocellular Carcinoma (HCC) trial by Guangxi Medical University. Stop reason: OTHER/UNKNOWN.

The support from the relevant company was not obtained as planned

Phase I Hepatocellular Carcinoma trial by University of Florida. Stop reason: OPERATIONAL.

funding terminated

Phase II End Stage Liver Disease trial by Baylor Research Institute. Stop reason: OPERATIONAL.

PI left institution

Phase III Nonalcoholic Steatohepatitis (NASH) trial by Galmed Research and Development, Ltd.. Stop reason: EFFICACY/FUTILITY.

Interim analysis results from the open-label part of the study. The double blind portion of the study will be resumed once the study will continue.

Phase IV Colitis, Ulcerative trial by Bristol-Myers Squibb. Stop reason: OTHER/UNKNOWN.

Business objectives have changed.

Phase I Advanced Gastrointestinal Tumors trial by Peking University. Stop reason: OTHER/UNKNOWN.

achieved the proof of concept

Phase I Pancreatic Ductal Adenocarcinoma trial by Boehringer Ingelheim. Stop reason: EFFICACY/FUTILITY.

Primary endpoint not met

Phase I Pancreatic Cancer trial by University of Pennsylvania. Stop reason: OPERATIONAL.

Administrative reasons

Phase I Crohn's Disease trial by Joshua M Hare. Stop reason: OPERATIONAL.

Study is permanently closed to enrollment

Phase I Ulcerative Colitis (UC) trial by Vial Australia Pty Ltd. Stop reason: EFFICACY/FUTILITY.

Study terminated based on interim analysis results indicating the primary pharmacokinetic endpoint was unlikely to be met.

Phase IV Crohn's Disease trial by Takeda. Stop reason: OPERATIONAL.

Sponsor decision

Phase I Chronic Hepatitis B trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

The Sponsor decided to discontinue the development of RO7565020 and as a result the BP44118 study was terminated.

Phase I Pancreatic Cancer trial by Takeda. Stop reason: EFFICACY/FUTILITY.

Clinical Futility of TAK 500 met. No further development with this compound

Unknown Irritable Bowel Syndrome trial by Washington University School of Medicine. Stop reason: OTHER/UNKNOWN.

Due to changes in trial personnel (co-investigator and research coordinator leaving the institution).

Phase II Gastric and Gastro-oesophageal Junction (GEJ) Adenocarcinomas trial by Institut Cancerologie de l'Ouest. Stop reason: OPERATIONAL.

Discontinuation of product manufacturing by the funder prior to the start of participant enrollment

Phase II Immune Checkpoint Inhibitor-Related Diarrhea and Colitis trial by Yale University. Stop reason: OTHER/UNKNOWN.

The study was terminated early as no patients were enrolled.

Phase II Acute-On-Chronic Liver Failure trial by Genfit. Stop reason: OPERATIONAL.

Sponsor Decision

Phase II Neuroendocrine Tumor G1 (NET G1)/Carcinoid trial by Imperial College London. Stop reason: OPERATIONAL.

The study has closed earlier than planned due to one of the funders decision to withdraw the financial support for the study.

Phase II Hepatitis B trial by Arrowhead Pharmaceuticals. Stop reason: OPERATIONAL.

Company decision to discontinue trial

Phase II Hepatitis B trial by Arrowhead Pharmaceuticals. Stop reason: OPERATIONAL.

Company decision to discontinue trial

Phase II Hepatitis B, Chronic trial by Arrowhead Pharmaceuticals. Stop reason: OPERATIONAL.

Company decision to discontinue trial

Phase II Hepatitis B trial by Arrowhead Pharmaceuticals. Stop reason: OPERATIONAL.

Company decision to discontinue trial

Phase II Ulcerative Colitis trial by Amgen. Stop reason: EFFICACY/FUTILITY.

The study was terminated due to meeting a prespecified futility rule and not related to any safety concerns.

Phase II Hepatitis B trial by Arrowhead Pharmaceuticals. Stop reason: OPERATIONAL.

Company decision to discontinue trial

Phase I Hepatic Insufficiency trial by Bristol-Myers Squibb. Stop reason: OPERATIONAL.

Insufficient Enrollment

Phase I Hepatitis B trial by Arrowhead Pharmaceuticals. Stop reason: OPERATIONAL.

Company decision to discontinue trial

Phase II Hepatic Encephalopathy trial by Genfit. Stop reason: OPERATIONAL.

Sponsor decision

Phase I Advanced Pancreatic Cancer trial by Ascentage Pharma Group Inc.. Stop reason: OPERATIONAL.

Company Strategy