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Clinical Trial Summary

The purpose of the study is to provide use of Omegaven in children with life threatening Total Parenteral Nutrition (TPN) associated cholestasis when all other medical and surgical treatments/therapies have been either ineffective or not feasible in the treatment of this serious condition. This is a compassionate use protocol.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Cholestasis
  • Total Parenteral Nutrition-induced Cholestasis

NCT number NCT01323907
Study type Interventional
Source Columbia University
Contact
Status Withdrawn
Phase N/A
Start date January 2011
Completion date February 13, 2019

See also
  Status Clinical Trial Phase
Completed NCT02370251 - Compassionate Use of Omegaven in Children Phase 2/Phase 3
Completed NCT01845116 - Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury Phase 2
Recruiting NCT01565278 - Fish Oil for Patients With Liver Disease Due to Parenteral Nutrition Phase 3
Terminated NCT00816348 - Compassionate Use of Omegaven IV Fat Emulsion Phase 2
Completed NCT02534077 - Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants Phase 3
Approved for marketing NCT02929303 - Expanded Access of Omegaven IV Fat Emulsion to Infants and Children With PNALD
Approved for marketing NCT02328768 - Compassionate Use of Omegaven® for the Treatment of Intestinal Failure Associated Liver Disease in Children
Approved for marketing NCT02780193 - Intravenous Fish Oils in the Treatment of Parenteral Nutrition Liver Injury
Approved for marketing NCT01412359 - Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Associated Hepatic Injury