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Compassionate Use of Omegaven for Pediatric Patients With Parenteral Nutrition Associated Liver Disease

NCT01297933 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2019-04-12

No results posted yet for this study

Summary

A compassionate use protocol to provide Omegaven to pediatric patients with parenteral nutrition (PN) dependence and parenteral nutrition associated liver disease (PNALD).

Conditions

  • Cholestasis
  • Short Bowel Syndrome

Interventions

DRUG

Omegaven

10% Omegaven 1g/kg/day, Intravenous by continuous infusion in conjunction with parenteral nutrition, until the patient no longer requires parenteral nutrition or until participation in the study is terminated.

Sponsors & Collaborators

Principal Investigators

  • Maria Mascarenhas, MBBS · Children's Hospital of Philadelphia

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01297933 on ClinicalTrials.gov