Autopsy report · NCT05677126

Tralement vs. Fixed-dose Trace Element Combination Product in Patients >3 to 17 Years of Age Requiring Long-term PN

“The Tralement Pediatric Safety Study has faced significant challenges in site recruitment and feasibility”

The sponsor’s own words in the registry.

Life of this trial

• Withdrawn before it enrolled anyone. Its dates are the sponsor's plans, not events that happened.

Vital statistics

Status

Withdrawn

Phase

Phase 4

Sponsor

American Regent, Inc.

Sponsor type

Industry

Conditions

Manganese Safety in Pediatric Patients

Interventions

Tralement; Fixed-dose trace element combination product of zinc, copper, and selenious acid

Participants

0

Trials that died the same way

• Comparison of Tissue in Regenerative Endodontic Procedures and Apexification
  “Lack of pediatric recruitment ability” (61% 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.