Parenteral nutrition-associated cholestasis

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1FDA treatments2Active trials24Specialists8Treatment centers

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Overview

Parenteral nutrition-associated cholestasis (PNAC), also called parenteral nutrition-associated liver disease (PNALD) or intestinal failure-associated liver disease (IFALD), is a serious liver condition that develops in people who receive nutrition through an intravenous (IV) line — called parenteral nutrition or total parenteral nutrition (TPN) — instead of eating normally. When the gut cannot absorb food properly, nutrients must be delivered directly into the bloodstream. Over time, this can cause bile to build up in the liver, leading to liver damage and scarring. The condition most commonly affects premature babies and newborns who have serious intestinal problems, such as short bowel syndrome, but it can also occur in older children and adults who depend on long-term IV nutrition. The liver becomes inflamed and, if untreated, can progress to cirrhosis or liver failure. Key symptoms include yellowing of the skin and eyes (jaundice), a swollen belly, pale or clay-colored stools, dark urine, and poor weight gain in infants. Treatment focuses on reducing or stopping parenteral nutrition as soon as possible, transitioning to feeding through the gut, and managing complications. In severe cases, a liver or combined liver-intestine transplant may be needed. Newer IV fat formulas, such as fish oil-based lipid emulsions, have shown promise in preventing and treating this condition.

Also known as:

Key symptoms:

Yellowing of the skin and whites of the eyes (jaundice)Swollen or enlarged bellyPale, white, or clay-colored stoolsDark yellow or brown urinePoor weight gain or growth failure in infantsItchy skinFatigue and low energyEnlarged liver or spleenEasy bruising or bleedingFluid buildup in the belly (ascites)Irritability in infantsElevated liver enzymes on blood tests

Clinical phenotype terms (22)— hover any for plain English
Abnormal circulating fatty-acid concentrationHP:0004359Biliary hyperplasiaHP:0006560Abnormality of cytokine secretionHP:0011113Villous atrophyHP:0011473Elevated gamma-glutamyltransferase levelHP:0030948Abnormal metabolismHP:0032245
Inheritance

Sporadic

Usually appears on its own, not inherited from a parent

Age of Onset

Variable

Can begin at different ages, from infancy through adulthood

Orphanet ↗NORD ↗

FDA & Trial Timeline

3 events
Dec 2024Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment

Fresenius Kabi

TrialRECRUITING
Oct 2024Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients

Fresenius Kabi — PHASE4

TrialRECRUITING
Jul 2018

Omegaven: FDA approved

Omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC)

FDAcompleted

Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Treatments

1 available

Omegaven

fish oil triglycerides· Fresenius Kabi USA, LLCOrphan Drug

Omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC)

Clinical Trials

2 recruitingView all trials with filters →
Phase 41 trial
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
Phase 4
Actively Recruiting
PI: Jeffrey Rudolph, MD (University of Pittsburgh) · Sites: Atlanta, Georgia; Chicago, Illinois +3 more · Age: 017 yrs
Other1 trial
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
Actively Recruiting
· Sites: Fountain Valley, California; Los Angeles, California +8 more · Age: 017 yrs

Specialists

24 foundView all specialists →
IP
Ibrahim Mohamed, MB ChB, DIS P
Specialist
PI on 1 active trial
JM
Josianne Malo, B.Pharm, M.Sc.
Specialist
PI on 1 active trial
JM
Jeffrey Rudolph, MD
CLARKSVILLE, TN
Specialist
PI on 1 active trial
RM
Richard A Ehrenkranz, MD
Specialist
PI on 1 active trial
CO
Chief Scientific Operations Officer
Specialist
PI on 3 active trials
MM
Meghan A Arnold, MD
Specialist
PI on 2 active trials
AM
Andreas Repa, MD
Specialist
PI on 2 active trials
KM
Kunal Gupta, MD
Specialist
PI on 1 active trial
NM
Nadja Haiden, MD
Specialist
PI on 2 active trials
LM
Lynn M Iwamoto, MD
HONOLULU, HI
Specialist
PI on 1 active trial
SM
Sanjiv Amin, MD
ROCHESTER, NY
Specialist
PI on 1 active trial
DP
David F Mercer, MD, PhD
Specialist
PI on 1 active trial
IM
Ian J Griffin, MD
WILTON MANORS, FL
Specialist
PI on 1 active trial
WM
Wencheng Kong, MD
Specialist
PI on 2 active trials
TV
Terra R Varner
Specialist
PI on 1 active trial
SA
Susan Albersheim
Specialist
PI on 1 active trial
SL
Sarah Lazar
Specialist
PI on 1 active trial
CH
Cindy Haller
CHESTERFIELD, MO
Specialist
PI on 1 active trial
BO
Bankole O Osuntokun
FORT WORTH, TX
Specialist
PI on 1 active trial
MM
Maria Mascarenhas
PHILADELPHIA, PA
Specialist
PI on 1 active trial
KC
Kara L Calkins
LOS ANGELES, CA
Specialist
PI on 2 active trials
DT
Daniel Hillel Teitelbaum
DENVER, CO
Specialist
PI on 1 active trial
TB
Tyler Burpee
BOISE, ID
Specialist
PI on 1 active trial

Treatment Centers

8 centers
🏥 NORD

Baylor College of Medicine Rare Disease Center

Baylor College of Medicine

📍 Houston, TX

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

🔬 UDN

UCLA UDN Clinical Site

UCLA Health

📍 Los Angeles, CA

🔬 UDN

Baylor College of Medicine UDN Clinical Site

Baylor College of Medicine

📍 Houston, TX

🔬 UDN

Harvard/MGH UDN Clinical Site

Massachusetts General Hospital

📍 Boston, MA

🏥 NORD

Mayo Clinic Center for Individualized Medicine

Mayo Clinic

📍 Rochester, MN

👤 Mayo Clinic Center for Individualized Medicine

🏥 NORD

UCLA Rare Disease Day Program

UCLA Health

📍 Los Angeles, CA

Travel Grants

No travel grants are currently matched to Parenteral nutrition-associated cholestasis.

Search all travel grants →NORD Financial Assistance ↗

Community

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Latest news about Parenteral nutrition-associated cholestasis

Disease timeline:

New recruiting trial: Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment

A new clinical trial is recruiting patients for Parenteral nutrition-associated cholestasis

New recruiting trial: Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients

A new clinical trial is recruiting patients for Parenteral nutrition-associated cholestasis

Caregiver Resources

NORD Caregiver Resources

Support, advocacy, and financial assistance for caregivers of rare disease patients.

Mental Health Support

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Family & Caregiver Grants

Financial assistance programs specifically for caregivers of rare disease patients.

Social Security Disability

Learn how rare disease patients may qualify for SSDI/SSI benefits.

Questions for your doctor

Bring these to your next appointment

  • Q1.How severe is the liver damage right now, and is it reversible?,Is my child (or am I) a candidate for switching to a fish oil-based IV fat formula?,What is the plan to transition to gut feeding, and how quickly can we try?,Should we consider a referral to an intestinal rehabilitation program?,At what point would a liver or intestine transplant be considered?,What blood tests should we monitor, and how often?,Are there any clinical trials or newer treatments we should know about?

Common questions about Parenteral nutrition-associated cholestasis

What is Parenteral nutrition-associated cholestasis?

Parenteral nutrition-associated cholestasis (PNAC), also called parenteral nutrition-associated liver disease (PNALD) or intestinal failure-associated liver disease (IFALD), is a serious liver condition that develops in people who receive nutrition through an intravenous (IV) line — called parenteral nutrition or total parenteral nutrition (TPN) — instead of eating normally. When the gut cannot absorb food properly, nutrients must be delivered directly into the bloodstream. Over time, this can cause bile to build up in the liver, leading to liver damage and scarring. The condition most common

How is Parenteral nutrition-associated cholestasis inherited?

Parenteral nutrition-associated cholestasis follows a sporadic inheritance pattern. Genetic counseling can help families understand recurrence risk and testing options.

Are there clinical trials for Parenteral nutrition-associated cholestasis?

Yes — 2 recruiting clinical trials are currently listed for Parenteral nutrition-associated cholestasis on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.

Which specialists treat Parenteral nutrition-associated cholestasis?

24 specialists and care centers treating Parenteral nutrition-associated cholestasis are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.

What treatment and support options exist for Parenteral nutrition-associated cholestasis?

1 patient support program are currently tracked on UniteRare for Parenteral nutrition-associated cholestasis. See the treatments and support programs sections for copay assistance, eligibility, and contact details.