Autopsy report · NCT03221842

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.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 4 months before it started.
• Ran for about 3 years 2 months before it stopped.
• 63 participants enrolled.
• Results were posted on the registry 1 year after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

CSL Behring

Sponsor type

Industry

Conditions

Antibody-mediated Rejection

Interventions

C1-esterase inhibitor; Placebo

Participants

63

Sites

26

Countries

Belgium, France, Germany, Netherlands, Spain, United Kingdom, United States

Trials that died the same way

• Safety and Tolerability of PNT001 in Patients With Acute Traumatic Brain Injury (TBI)
  “The study was terminated due to administrative, non-safety related reasons.” (85% match in meaning)
• Satavaptan for the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver
  “Study was terminated due to safety reason.” (85% match in meaning)
• Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy
  “This study was prematurely terminated due to low enrollment and not for safety reasons.” (85% match in meaning)
• Placebo Controlled Trial of Bosentan in Scleroderma Patients
  “Study was terminated due to inadequate enrolment” (85% match in meaning)
• A Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients
  “The study has been early terminated due to business reasons. This decision is not related to any safety, efficacy, or regulatory concerns.” (84% 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.