Omegaven Therapy for Cholestasis

Phase 2

Waitlist Available

Led By Terra R Varner, PharmD

Research Sponsored by Amarnath, Rathna, M.D.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up labwork will be collected at baseline, then weekly for the first month. thereafter, a lipid panel will be collected every 2 months, complete metabolic panel every 2 weeks, and essential fatty acid profile monthly, up to an expected average of 108 weeks

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

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.

Eligible Conditions

Cholestasis
Short Bowel Syndrome
Liver Injury

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ labwork will be collected at baseline, then weekly for the first month. thereafter, a lipid panel will be collected every 2 months, complete metabolic panel every 2 weeks, and essential fatty acid profile monthly, up to an expected average of 108 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~labwork will be collected at baseline, then weekly for the first month. thereafter, a lipid panel will be collected every 2 months, complete metabolic panel every 2 weeks, and essential fatty acid profile monthly, up to an expected average of 108 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and labwork will be collected at baseline, then weekly for the first month. thereafter, a lipid panel will be collected every 2 months, complete metabolic panel every 2 weeks, and essential fatty acid profile monthly, up to an expected average of 108 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvement of liver dysfunction as measured by time to achieve 50 % decrease in direct bilirubin

Secondary study objectives

Occurrence of potential adverse side effects

a) Maintenance of nutritional status

c) Resolution of liver dysfunction

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Omegaven TherapyExperimental Treatment1 Intervention

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.

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