Autopsy report · NCT00969332

A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease

“study intervention was approved by the FDA”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 9 years 6 months before it stopped.
• 62 participants enrolled.
• Results were posted on the registry 1 year after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

University of California, Los Angeles

Sponsor type

University, hospital or other

Conditions

Cholestasis

Interventions

Omegaven

Participants

62

Sites

1

Countries

United States

Trials that died the same way

• Comparison Study of PET/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer
  “Study Drug was FDA approved Summer 2021” (73% match in meaning)
• Safety of SP-420 in the Treatment of Transfusional Iron Overload
  “Study is on hold by FDA in the US.” (72% match in meaning)
• A Phase 2, Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pefcalcitol Ointment, 0.005%, Applied Topically Twice Daily (BID) for 8 Weeks in Adolescent Subjects 12 to < 17 Years of Age With Plaque Psoriasis
  “FDA requested us to stop the study” (71% match in meaning)
• A Dose Exploration Study With Birabresib (MK-8628) in Participants With Selected Hematologic Malignancies (MK-8628-005)
  “This study was terminated due to limited efficacy and not due to safety reasons” (67% match in meaning)
• Subcutaneous Recombinant Human Hyaluronidase: Workflow Analysis and Emergency Department Design
  “This study was closed before accrual due to FDA recall of Medication” (67% 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.