Phase IV clinical trial failures

Phase IV Post-traumatic Stress Disorder trial by University of California, San Francisco. Stop reason: OPERATIONAL.

Unable to meet enrollment goals

Phase IV Sedation trial by Nanfang Hospital, Southern Medical University. Stop reason: OPERATIONAL.

The trial was terminated early because additional sites did not recruit as planned, making the multicenter sample size infeasible. Enrollment ended after 117 participants were randomized at Nanfang Hospital, unrelated to safety, efficacy, or outcomes

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

Resources

Phase IV Appendicitis trial by University of California, San Francisco. Stop reason: OPERATIONAL.

Not feasible to complete trial due to low enrollment rate. Enrollment terminated and inadequately powered to achieve statistical significance on primary and secondary study outcomes.

Phase IV Familial Mediterranean Fever (FMF ) trial by Swedish Orphan Biovitrum. Stop reason: OPERATIONAL.

Business decision.

Phase IV Drug-resistant Focal Seizure trial by Beth Israel Deaconess Medical Center. Stop reason: OPERATIONAL.

Failure to recruit subjects.

Phase IV Congenital Hypothyroidism trial by IBSA Institut Biochimique SA. Stop reason: OPERATIONAL.

Inability to recruit subjects

Phase IV Valvular Heart Surgery trial by SHI Jia. Stop reason: OTHER/UNKNOWN.

At a meeting on February 17, 2025, the Data and Safety Monitoring Board recommended early termination because the predefined efficacy boundary was crossed.

Phase IV Transformed Migraine trial by Rutgers, The State University of New Jersey. Stop reason: OPERATIONAL.

no patients during covid pandemic

Phase IV Surgical Site Infection trial by The University of Texas Medical Branch, Galveston. Stop reason: EFFICACY/FUTILITY.

Futility

Phase IV Pregnancy Preterm trial by University Hospitals Cleveland Medical Center. Stop reason: OPERATIONAL.

Low enrollment

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.

Phase IV Endometriosis trial by University of Louisville. Stop reason: OPERATIONAL.

Principal investigator did not have the necessary staffing resources to continue the study.

Phase IV Nail Psoriasis trial by Weill Medical College of Cornell University. Stop reason: OPERATIONAL.

The study was terminated due to slow accrual.

Phase IV Posttraumatic Stress Disorder trial by VA Office of Research and Development. Stop reason: OPERATIONAL.

difficulty meeting recruitment goals

Phase IV Cesarean Section trial by Centre Hospitalier Universitaire de Nīmes. Stop reason: OTHER/UNKNOWN.

No inclusions.

Phase IV Diabetes Mellitus, Type 2 trial by University of Illinois at Chicago. Stop reason: OPERATIONAL.

Low recruitment rate and an inability to meet power.

Phase IV Otitis Media trial by Boston Children's Hospital. Stop reason: OPERATIONAL.

There was limited enrollment in the study.

Phase IV Primary Pulmonary Arterial Hypertension trial by Heidelberg University. Stop reason: OPERATIONAL.

Strategic re-prioritization by the IMP supplier. Decision not safety-related

Phase IV Aortic Stenosis, Non-rheumatic trial by University Hospital, Montpellier. Stop reason: OTHER/UNKNOWN.

Difficulty of inclusion

Phase IV Recovery Following Cholecystectomy trial by Rutgers, The State University of New Jersey. Stop reason: OPERATIONAL.

The study was halted due to the worldwide COVID-19 pandemic and the cancellation of all elective cases.

Phase IV Metrorrhagia trial by University of Chicago. Stop reason: OTHER/UNKNOWN.

Data not collected and analyzed; withdrawn due to lack of bandwidth.

Phase IV Respiratory Failure trial by Beth Israel Deaconess Medical Center. Stop reason: OPERATIONAL.

Study terminated due to lack of enrollment.

Phase IV Aplastic Anemia trial by Peking Union Medical College Hospital. Stop reason: OTHER/UNKNOWN.

This is a duplicate registration. The research plan and content have already been updated in another entry.

Phase IV Spondylitis, Ankylosing trial by Johnson & Johnson Taiwan Ltd. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase IV Anatomic Stage I Breast Cancer AJCC v8 trial by University of Washington. Stop reason: OPERATIONAL.

Study ended earlier than anticipated due to end of funding.

Phase IV Arthroplasty, Replacement, Knee trial by McMaster University. Stop reason: OPERATIONAL.

Unable to secure funding.

Phase IV HIV-1-infection trial by Trieu, Nguyen Thi, M.D.. Stop reason: OPERATIONAL.

The study was withdrawn before enrollment due to administrative and board approval constraints.

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

slow recruitment rate

Phase IV Osteo Arthritis Knee trial by University of Calgary. Stop reason: OPERATIONAL.

The study has been stopped due to logistical reasons at the clinical site.

Phase IV Otolaryngologic Surgery trial by University of Minnesota. Stop reason: OTHER/UNKNOWN.

The current PI is leaving the study. Study team is awaiting FDA PI change approval.

Phase IV Peripheral Arterial Disease trial by Mayo Clinic. Stop reason: OPERATIONAL.

Lack of funds

Phase IV Hiv trial by Chelsea and Westminster NHS Foundation Trust. Stop reason: OPERATIONAL.

The CI, sponsor and funder jointly made the decision to end the trial due to lack of recruitment, as well as due to delays it was felt value of the primary endpoint had lessened to a point where its scientific value was questioned.

Phase IV Post Operative Pain trial by Baptist Health South Florida. Stop reason: OPERATIONAL.

Study discontinued due to feasibility challenges related to participant recruitment

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

Difficulty with enrollment

Phase IV Depression, Unipolar trial by New York State Psychiatric Institute. Stop reason: OTHER/UNKNOWN.

The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.

Phase IV Infant Mortality trial by Bandim Health Project. Stop reason: OTHER/UNKNOWN.

Due to fewer than expected children enrolled and lower than expected overall mortality rate.

Phase IV ST Elevation Myocardial Infarction (STEMI) trial by Henan Institute of Cardiovascular Epidemiology. Stop reason: OPERATIONAL.

Slow patient enrollment and lack of financial support

Phase IV Atopic Dermatitis trial by Psoriasis Treatment Center of Central New Jersey. Stop reason: OTHER/UNKNOWN.

Principal Investigator retired

Phase IV Von Willebrand Disease trial by Grifols Therapeutics LLC. Stop reason: OPERATIONAL.

Due to recruitment difficulties for pediatric patients. The reason for study cancellation is not related to safety concerns or any adverse events.

Phase IV Post-Traumatic Stress Disorder trial by Donald Jeffrey Newport. Stop reason: OPERATIONAL.

Loss of funding.

Phase IV PANDAS trial by Massachusetts General Hospital. Stop reason: OPERATIONAL.

Low recruitment

Phase IV Prurigo Nodularis trial by Psoriasis Treatment Center of Central New Jersey. Stop reason: OPERATIONAL.

There was not a big enough patient population to meet recruitment goals

Phase IV HIV Lipodystrophy Syndrome trial by Columbia University. Stop reason: OTHER/UNKNOWN.

lack of availability of the study drug

Phase IV COVID-19 trial by Nicholas Carlson. Stop reason: OPERATIONAL.

No funding

Phase IV Naltrexone HCl 50 MG Oral Tablet trial by Texas Tech University. Stop reason: OPERATIONAL.

Funding unexpectedly withdrawn

Phase IV Acute Gout trial by University Medicine Greifswald. Stop reason: OPERATIONAL.

The study was terminated due to an inability to reach the planned sample size, despite efforts to enhance recruitment.

Phase IV Pain Control trial by Mayo Clinic. Stop reason: SAFETY.

Study participant had a related adverse event that prompted interim data analysis and additional study participants were not sought.

Phase IV Rheumatoid Arthritis trial by Platelet and Thrombosis Research, LLC. Stop reason: OPERATIONAL.

Our group moved from Inova Heart and Vascular institute to Sinai Hospital with Platelet and Thrombosis, LLC taking over sponsorship. Study was then IRB approved at Sinai on March, 2020 but closed prior to any additional enrolment due to COVID.

Phase IV Endometriosis trial by University Hospitals Cleveland Medical Center. Stop reason: OTHER/UNKNOWN.

Study never opened

Phase IV End Stage Renal Disease on Dialysis trial by University of Alberta. Stop reason: OPERATIONAL.

Personnel/staffing issues.

Phase IV Opioid Use Disorder trial by Theresa Jacob, PhD, MPH. Stop reason: OTHER/UNKNOWN.

Principal Investigator is no longer at this site

Phase IV Dry Eye Disease (DED) trial by Medical University of Vienna. Stop reason: OTHER/UNKNOWN.

This study was not halted prematurely. This record represents a duplicate entry and has therefore been withdrawn. The correct and complete study information can be found under identifier NCT07007702.

Phase IV Substance Use Disorders trial by Montefiore Medical Center. Stop reason: OPERATIONAL.

Difficulty recruiting and enrolling participants

Phase IV Glaucoma, Open-Angle trial by Laboratorios Sophia S.A de C.V.. Stop reason: OTHER/UNKNOWN.

For interests of sponsor.

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 IV Preterm Prelabor Rupture of Membranes (PPROM) trial by The University of Texas Health Science Center, Houston. Stop reason: OTHER/UNKNOWN.

PI has decided to end study due to changes in Texas law and no participants were enrolled

Phase IV Parathyroid Dysfunction trial by University of Alabama at Birmingham. Stop reason: OPERATIONAL.

Funding halted

Phase IV Coronary Artery Disease trial by Ottawa Heart Institute Research Corporation. Stop reason: OTHER/UNKNOWN.

Testing supplies unavailable.

Phase IV Postpartum Pregnancy-Induced Hypertension trial by Columbia University. Stop reason: OPERATIONAL.

Principal investigator left the institution

Phase IV Endocarditis trial by West Virginia University. Stop reason: OTHER/UNKNOWN.

The study was stopped because all five participants were lost to follow-up before completing treatment or any assessments, leaving no outcome data available and making continuation of the trial infeasible.

Phase IV Fetal Cardiac Rhythm Abnormalities trial by University Hospital, Rouen. Stop reason: OTHER/UNKNOWN.

Data analysis issue

Phase IV Delirium trial by University of Southern California. Stop reason: OPERATIONAL.

PI left institution. Study never started.

Phase IV Multiple Myeloma trial by Takeda. Stop reason: OTHER/UNKNOWN.

All participants on the study have concluded treatment, core study activities are complete, and the scientific goals of the study have been met.

Phase IV Ventricular Tachycardia trial by Ottawa Heart Institute Research Corporation. Stop reason: OPERATIONAL.

Low recruitment. Pilot trial.

Phase IV Sarcoidosis trial by University of California, San Francisco. Stop reason: OTHER/UNKNOWN.

sponsor closed study down

Phase IV Distal Radius Fracture trial by C. Liam Dwyer. Stop reason: OPERATIONAL.

Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)

Phase IV Polycythemia Vera trial by Novartis Pharmaceuticals. Stop reason: OPERATIONAL.

Sponsor decision

Phase IV Total Shoulder Arthroplasty trial by Johnny K. Lee. Stop reason: EFFICACY/FUTILITY.

Due to resource limitations and the lack of difference observed between study groups after the interim analysis, the study was halted prematurely.

Phase IV Migraine Headaches trial by Icahn School of Medicine at Mount Sinai. Stop reason: OTHER/UNKNOWN.

Study closing at current site. Study to start as new at different site.

Phase IV ANCA Associated Vasculitis trial by Guy's and St Thomas' NHS Foundation Trust. Stop reason: OPERATIONAL.

Recruitment was terminated early by the funder due to study sites' inability to recruit sufficient number of participants.

Phase IV Heart Failure trial by Sarfez Pharmaceuticals, Inc.. Stop reason: OPERATIONAL.

Recruitment issues

Phase IV Myocardial Infarction trial by Seoul National University Hospital. Stop reason: OTHER/UNKNOWN.

The study was terminated early due to a shortage of research and analytical personnel, which prevented the completion of the study as planned

Phase IV Variant Angina trial by Seoul National University Hospital. Stop reason: OPERATIONAL.

The study was terminated early due to slow recruitment and the Principal Investigator's retirement.

Phase IV Chronic Pain trial by Massachusetts General Hospital. Stop reason: OPERATIONAL.

End of NIH funding

Phase IV Oligometastatic Disease trial by University of Colorado, Denver. Stop reason: OPERATIONAL.

Low Accrual

Phase IV Acute Hyperkalemia trial by University of California, Irvine. Stop reason: OPERATIONAL.

Low enrollment rate

Phase IV Melanoma BRAF V600E/K Mutated trial by SRH Wald-Klinikum Gera GmbH. Stop reason: OPERATIONAL.

The study was terminated early due to insufficient patient recruitment.

Phase IV IUD Insertion Pain trial by University of Missouri-Columbia. Stop reason: OPERATIONAL.

Inadequate recruitment

Phase IV Palmoplantar Psoriasis trial by Bristol-Myers Squibb. Stop reason: OTHER/UNKNOWN.

Business objectives have changed

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 IV Bipolar Depression trial by New York State Psychiatric Institute. Stop reason: OPERATIONAL.

Funding decision

Phase IV Postoperative Pain Management trial by Shenyang Sixth People's Hospital. Stop reason: OTHER/UNKNOWN.

needs major change in study protocol

Phase IV Distributive Shock trial by Northwestern University. Stop reason: OPERATIONAL.

Enrollment Challenges

Phase IV Pain trial by Insel Gruppe AG, University Hospital Bern. Stop reason: OPERATIONAL.

Recruitment difficulties

Phase IV Kidney Failure, Chronic trial by Centre Hospitalier Departemental Vendee. Stop reason: OPERATIONAL.

Recruitment difficulties

Phase IV Dry Eye trial by Scripps Poway Eyecare and Optometry. Stop reason: OPERATIONAL.

investigator decision

Phase IV Laparoscopic Surgery trial by Peking University First Hospital. Stop reason: EFFICACY/FUTILITY.

The study was terminated due to substantial protocol amendments involving changes in the target population and primary endpoint, rendering previously collected data incompatible with the revised study objective.

Phase IV Palmoplantar Pustulosis trial by Brigham and Women's Hospital. Stop reason: OPERATIONAL.

Sponsor terminated funding

Phase IV Hemophilia A trial by University of Texas Southwestern Medical Center. Stop reason: OPERATIONAL.

Due to COVID-19 pandemic, recruitment was temporarily put on hold. We are withdrawing this registration due to a recent amendment to the protocol that includes major changes to data elements. A new registration will be submitted for the new protocol.

Phase IV Duchenne Muscular Dystrophy trial by Rare Disease Research, LLC. Stop reason: OTHER/UNKNOWN.

The Sponsor has decided to focus their resources on other areas of therapy.

Phase IV Small for Gestational Age trial by Assistance Publique - Hôpitaux de Paris. Stop reason: OTHER/UNKNOWN.

no more inclusions

Phase IV Postoperative Pain trial by Olivia Sher. Stop reason: OPERATIONAL.

PI left institution

Phase IV Cannabis Use trial by University of Oklahoma. Stop reason: OPERATIONAL.

Principal Investigator failed to submit required annual review. Study was administratively closed by the IRB.

Phase IV Esophageal Adenocarcinoma trial by University of Chicago. Stop reason: OTHER/UNKNOWN.

Pending data analysis

Phase IV Ligament Tear Knee trial by George F. Hatch. Stop reason: OTHER/UNKNOWN.

FDA withdrew approval of the study product

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

reason of halt prematurely: futility of the trial

Phase IV Endoscopy trial by Stanford University. Stop reason: OTHER/UNKNOWN.

We do not have access to the patient population anymore due to a move in our operational design

Phase IV Shoulder Pain trial by Claire Bourgeois. Stop reason: OPERATIONAL.

The decision to discontinue the project is based on several factors, including organizational constraints, lack of funding, and insufficient participant interest in taking part.

Phase IV Kidney Transplant Immunosuppression trial by CAMC Health System. Stop reason: OTHER/UNKNOWN.

The PI is relocating to another State/ another hospital