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Trial record 24 of 82 for:    Recruiting, Not yet recruiting, Available Studies | "Cholestasis"

Omegaven for Compassionate Use in the Treatment of Parenteral Nutrition-Associated Liver Disease

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ClinicalTrials.gov Identifier: NCT03072667
Recruitment Status : Available
First Posted : March 7, 2017
Last Update Posted : March 14, 2018
St. Louis University
Information provided by (Responsible Party):
Catherine Cibulskis, MD, Saint Louis University

Brief Summary:
This is a compassionate use protocol of an investigational new drug (IND). The overall purpose of the treatment is to offer alternative treatment to children who developed parenteral nutrition-associated liver disease (PNALD) and have not responded positively to currently available medical therapies. PNALD develops in newborns dependent on parenteral nutrition (PN) and are unable to tolerate adequate enteral feedings to support fluid and nutritional fluids; although PN is necessary and life sustaining, it can result in severe liver disease.

Condition or disease Intervention/treatment
Cholestasis Liver Diseases Drug: Omegaven

  Show Detailed Description

Study Type : Expanded Access
  Individual Patient
  Treatment IND/Protocol
Official Title: Omegaven for Compassionate Use in the Treatment of Parenteral Nutrition-Associated Liver Disease

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Intervention Details:
    Drug: Omegaven
    Omegaven™ will be initiated at 0.5 gm fat/kg of body weight per day (5cc/kg per day of Omegaven™) for 2 days. On day 3, the rate of Omegaven™ will be increased to 1g/kg (10cc/kg) per day and will remain at this level thereafter unless otherwise indicated.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All

Inclusion Criteria:

  1. Age < 1 years; inpatient use only
  2. PN dependency (unable to meet nutritional needs solely by enteral nutrition);
  3. Present PNALD, as evidenced by two consecutive direct bilirubin > 3.0 mg/dL (at interval of one week);
  4. Failed standard therapies to prevent the progression of liver disease:

    Avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding and the use of Ursodiol, if possible.

  5. At the time the diagnosis PNALD is made, the patient is expected to continue PN at least an additional 3 weeks

Exclusion Criteria:

  1. Any other cause of chronic liver disease (i.e., hepatitis B or C, cystic fibrosis, biliary atresia, or alpha 1 anti-trypsin deficiency etc.)
  2. enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team);
  3. Lack of informed consent;
  4. Intent to transfer to another healthcare facility
  5. allergy to any seafood product, egg protein, and/or previous allergy to Omegaven
  6. active coagulopathy characterized by ongoing bleeding or by a requirement for clotting factor replacement (e.g. fresh frozen plasma or cryoprecipitate) to maintain homeostasis
  7. impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis
  8. unstable DM or hyperglycemia
  9. stroke/embolism
  10. collapse and shock
  11. undefined coma status
  12. recent MI
  13. cholestasis due to any reason other than PNALD
  14. active new infection at time of initiation of Omegaven
  15. hemodynamic instability
  16. unable to tolerate necessary laboratory monitoring
  17. severe renal insufficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072667

Contact: Catherine Cibulskis, MD 314-577-5642 ccibulsk@slu.edu
Contact: Melissa Hawkins, MSN,RN, CPNP 314-577-5642 mbowles2@slu.edu

United States, Missouri
SSM Health Cardinal Glennon Children's Hospital
Saint Louis, Missouri, United States, 63104
Contact: Catherine Cibulskis, MD         
Contact: Melissa Hawkins, MSN,RN,CPNP         
Principal Investigator: Catherine Cibulskis, MD         
Sub-Investigator: Connie Anderson, MD         
Sponsors and Collaborators
Catherine Cibulskis, MD
St. Louis University


Responsible Party: Catherine Cibulskis, MD, Assistant Professor of Pediatrics, Saint Louis University
ClinicalTrials.gov Identifier: NCT03072667     History of Changes
Other Study ID Numbers: 16150
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

Keywords provided by Catherine Cibulskis, MD, Saint Louis University:
bowel atresia
necrotizing entercolitis
parenteral nutrition associated liver disease (PNALD)
intestinal failure
parenteral nutrition associated cholestasis
fish oil

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases