Autopsy report · NCT03198572

Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis

“Enrolment terminated early owing to slow accrual (repeat-biopsy burden and COVID-19 pandemic), following a protocol-specified interim analysis approved by the ethics committee (2017-050(5)).”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 months before it started.
• Ran for about 7 years 6 months before it stopped.
• 89 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

Fudan University

Sponsor type

University, hospital or other

Conditions

Non-alcoholic Steatohepatitis

Interventions

Lifestyle intervention; Placebo; Berberine

Participants

89

Sites

6

Countries

China

Trials that died the same way

• Predictive Value of Pre-TAVI Infrahissian Conduction Time in the Occurrence of Complete Atrioventricular Block
  “The sponsor, in consultation with the coordinating investigator, had decided to stop enrolment prematurely because the enrolment rate would not have made it possible to reach the target of 142 patients without increasing the duration of the study” (69% match in meaning)
• A Reminder App to Reduce Radiation Dermatitis Rates in Patients with Head-and-Neck Cancer
  “After the planned interim analysis, the study was terminated. The start of the trial was delayed due to data protection issues and the Covid-19 pandemic. Moreover, accrual was slower than expected. Finally, funding has expired.” (63% match in meaning)
• Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination: Feasibility Trial
  “Halted early due to poor accrual and lack of time to receive intervention procedures adjacent to a clinic visit post randomization.” (63% match in meaning)
• FFR-CT to Detect the Absence of Hemodynamically Significant Lesions in Patients With High-risk Acute Coronary Syndrome
  “Slow enrolment during the COVID pandemics” (63% match in meaning)
• Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients
  “The study was terminated early due to futility of enrolment and not for safety reasons.” (62% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.