CompletedPhase 2/3

Cholestasis Reversal: Efficacy of IV Fish Oil

United States91 participantsStarted 2006-08

Plain-language summary

The purpose of this study is to determine whether Omegaven is effective in the treatment of parenteral nutrition associated liver disease (PNALD).

Age range17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days
✓. Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of \> 2 mg/dl or currently on Omegaven through another protocol. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.
✓. Direct bilirubin \> 2.0 mg/dl or already on Omegaven through another protocol
✓. Signed patient informed consent.
✓. The patient must have utilized standard therapies to prevent the progression of his/her liver disease including surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, and the use of ursodiol (i..e., Actigall®).

✕. Pregnancy
✕. Other causes of chronic liver disease (Hepatitis C, biliary atresia, and alpha 1 anti-trypsin deficiency).
✕. Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
✕. The parent or guardian or child unwilling to provide consent or assent

Reversal of Cholestasis, Defined as a Direct Bilirubin to <= 2.0 mg/dL.

Timeframe: Duration of treatment

NCT IDNCT00910104

SponsorMark Puder

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-23

Results submitted2021-01-29

Who can participate

Age range17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days
✓. Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of \> 2 mg/dl or currently on Omegaven through another protocol. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.
✓. Direct bilirubin \> 2.0 mg/dl or already on Omegaven through another protocol
✓. Signed patient informed consent.
✓. The patient must have utilized standard therapies to prevent the progression of his/her liver disease including surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, and the use of ursodiol (i..e., Actigall®).

✕. Pregnancy
✕. Other causes of chronic liver disease (Hepatitis C, biliary atresia, and alpha 1 anti-trypsin deficiency).
✕. Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
✕. The parent or guardian or child unwilling to provide consent or assent