Cholestasis Clinical Trial
Official title:
Cholestasis Prevention: Efficacy of IV Fish Oil
Parenteral nutrition (PN) solutions are life saving in patients with surgical gastrointestinal diseases. However, the use of PN in pediatric populations, especially premature infants, is frequently associated with liver injury that may ultimately result in hepatic failure. In studies conducted in a murine model, we observed that intravenous fat emulsions (IFE) comprised of omega-3 fatty acids were able to prevent the development of cholestasis, a common precursor of PN-associated liver disease, as well as reverse preexisting PNALD through a combination of factors, including improved triglyceride clearance coupled with anti-inflammatory properties. In a case series treating patients with hepatic cholestasis, serum bilirubin levels decreased markedly after the parenteral administration of an omega-3 fatty acid based fat emulsion (Omegaven®). Patients tolerated this therapy and no adverse reactions attributed to its use were observed. Based on results of these previous studies, we propose to conduct a randomized trial aiming to gain preliminary evidence of efficacy of an omega-3 fatty acid based IFE in preventing PNALD in children with intestinal failure
We propose to conduct a randomized controlled clinical trial to determine whether the use of an omega-3 fatty acid based IFE in infants with surgical gastrointestinal disease will improve clinical outcomes compared to infants treated with standard IFE up to 6 months post randomization. Neonates and infants < 3 months old (postnatally) with surgical gastrointestinal disease (defined as congenital or acquired gastrointestinal disease requiring PN for more than 21 days) will be eligible for enrollment. Patients who meet all inclusion and exclusion criteria will be randomized to receive PN with either Intralipid® or Omegaven®. The appearance of both IFEs is indistinguishable, so patients, families and the medical care team will be blinded to treatment group allocation. Aside from the IFE type, the clinical care of both groups of infants will remain unchanged, including standard use of feeding advancement protocols, and treatment of underlying gastrointestinal and other diseases. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04510090 -
Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus
|
Phase 1 | |
Completed |
NCT02917408 -
Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
|
||
Completed |
NCT00738101 -
Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants
|
N/A | |
Completed |
NCT00004414 -
Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis
|
N/A | |
Completed |
NCT03662282 -
Omegaven as Alternative Parenteral Fat Nutrition
|
Phase 3 | |
Recruiting |
NCT02334293 -
Omegaven® as Parenteral Nutrition
|
N/A | |
Recruiting |
NCT01252043 -
Retrospective Review of CT and MR in Pediatric Patients With Cholestasis
|
N/A | |
Completed |
NCT00846963 -
Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates
|
Phase 2/Phase 3 | |
Completed |
NCT00007033 -
Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease
|
N/A | |
Completed |
NCT01194063 -
Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children
|
Phase 3 | |
Recruiting |
NCT01998620 -
Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis
|
Phase 4 | |
Completed |
NCT00080236 -
Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
|
Phase 2 | |
Completed |
NCT00058890 -
Gabapentin to Treat Itch in Patients With Liver Disease
|
Phase 3 | |
Active, not recruiting |
NCT00004315 -
Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease
|
Phase 2 | |
Active, not recruiting |
NCT02922751 -
FibroScan™ in Pediatric Cholestatic Liver Disease (FORCE)
|
||
Completed |
NCT04604652 -
Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
|
Phase 2 | |
Terminated |
NCT02267707 -
Pharmacokinetic and Safety Study of Nab®-Paclitaxel (ABI-007) Plus Gemcitabine in Subjects With Advanced Pancreatic Cancer Who Have Cholestatic Hyperbilirubinemia
|
Phase 1 | |
Completed |
NCT02357576 -
Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD
|
Phase 3 | |
Completed |
NCT02721277 -
SMOFlipid to Lessen the Severity of Neonatal Cholestasis
|
Phase 1/Phase 2 | |
Terminated |
NCT02767648 -
Inter-regional Cohort of Neonatal and Infant Cholestasis in the Greater Southwest Region
|
N/A |