Recruiting
Phase 2

Omega-3 Therapy

Sponsor:

Amarnath, Rathna, M.D.

Code:

NCT01739517

Conditions

Short Bowel Syndrome

Cholestasis

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Omegaven Therapy

Study Details

Brief summary:

This pilot study seeks to demonstrate the efficacy of an intravenous lipid preparation high in omega-3 fatty acids (Omegaven) in the treatment of cholestasis in parenteral nutrition dependent patients with short gut syndrome.

Conditions

Short Bowel Syndrome

Cholestasis

Study ID

NCT01739517

Start date

Mar, 2009

Status verified date

Nov, 2012

Completion date

Dec, 2013

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient will be dependent upon parenteral nutrition (PN)
  • Patient will have short gut syndrome (loss of >50% of small bowel)
  • Patient's guardian/caregiver provides informed consent for patient to receive therapy
  • Pediatric patient ≤ 1 year of age
  • Expected PN duration is greater than 30 days
  • Direct bilirubin >2.0 mg/dL measured on two occasions no more than one week apart

Exclusion Criteria:

  • Liver dysfunction secondary to cause other than PN verified by standard of care diagnostic procedures and lab work to rule out alternative causes of neonatal cholestasis.
  • Any patient in whom Omegaven therapy would be contraindicated, such as an allergy to any seafood product, egg protein, and/or previously established allergy to Omegaven
  • impaired lipid metabolism
  • severe hemorrhagic disorder
  • unstable diabetes mellitus
  • collapse and shock, stroke/embolism, recent cardiac infarction, or undefined coma status

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Omegaven Therapy

After baseline labs, which have been collected no earlier than seven days prior to the initiation of therapy are obtained, therapy with Omegaven will be initiated at a starting dose of 0.5 g/kg/day infused over 12 hours. If tolerated, the dose will be increased to 1 g/kg/day, the goal dose. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.

Interventions

Omegaven Therapy

After baseline labs, which have been collected no earlier than seven days prior to the initiation of therapy are obtained, therapy with Omegaven will be initiated at a starting dose of 0.5 g/kg/day infused over 12 hours. If tolerated, the dose will be increased to 1 g/kg/day, the goal dose. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.

Primary outcome measure

  • Improvement of liver dysfunction as measured by time to achieve 50 % decrease in direct bilirubin [ Time Frame: weekly then biweekly data collection ]

Central Contacts and Locations

Locations

Palmetto Health Children's Hospital

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Terra R Varner, PharmD

803-434-3034terra.varner@palmettohealth.org

Principal Investigator:

Terra R Varner, PharmD

More Information

Sponsor

Amarnath, Rathna, M.D.

Last update posted

Dec 3, 2012

Last verified

Nov, 2012

Keywords

  • Short bowel syndrome
  • Cholestasis
  • Omegaven
  • Parenteral nutrition-associated Liver Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Amarnath, Rathna, M.D. on 2012-12-03.