Familial intrahepatic cholestasis

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5Active trials4Specialists8Treatment centers

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Overview

Familial intrahepatic cholestasis (FIC) is a group of inherited liver diseases where bile — a digestive fluid made by the liver — cannot flow properly out of liver cells. When bile builds up inside the liver, it causes damage over time and leads to a range of symptoms. The condition is sometimes called progressive familial intrahepatic cholestasis, or PFIC, and it covers several subtypes caused by different gene changes. The most well-known subtypes are PFIC1, PFIC2, and PFIC3, each caused by a fault in a different gene. The main symptoms include severe, persistent itching (called pruritus), yellowing of the skin and eyes (jaundice), and poor growth in children. Over time, the liver can become scarred (cirrhosis), which may lead to liver failure if not treated. Some forms also affect other organs, such as the pancreas or intestines. Treatment aims to improve bile flow and relieve symptoms. Medications such as ursodeoxycholic acid and, more recently, FDA-approved drugs like odevixibat (Bylvay) and maralixibat (Livmarli) can help reduce bile acid buildup and itching. In more severe cases, surgery to divert bile flow or a liver transplant may be needed. Early diagnosis and treatment are important to protect the liver and improve quality of life.

Key symptoms:

Severe, constant itching all over the bodyYellowing of the skin and whites of the eyes (jaundice)Dark urinePale or greasy stoolsPoor weight gain and slow growth in infants and childrenSwollen belly due to fluid buildup (ascites)Fatigue and low energyEnlarged liver or spleenVitamin deficiencies (especially vitamins A, D, E, and K)Easy bruising or bleedingBone pain or weak bonesDiarrhea (in some subtypes)Hearing loss (in PFIC1 subtype)

Inheritance

Autosomal recessive

Passed on when both parents carry the same gene change; often skips generations

Age of Onset

Infantile

Begins in infancy, roughly 1 month to 2 years old

Orphanet ↗NORD ↗

FDA & Trial Timeline

6 events
Apr 2026Retrospective Observational Study of Odevixibat Outcomes in Patients With PFIC Versus an External Control Cohort (OvEC-PFIC)

Ipsen

TrialNOT YET RECRUITING
Dec 2025A Study to Assess the Genetic Variations in Bile Flow Disorders: Linking Progressive Familial Intrahepatic Cholestasis (PFIC)-Related Genes to Symptoms in Adults With Recurrent Cholestasis in Spain

Ipsen

TrialRECRUITING
Oct 2025A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in South Korea

Ipsen

TrialRECRUITING
Oct 2024Familial Intrahepatic Cholestasis-related Genes Associated with Disease Susceptibility in Hepato-biliary Cancers

IRCCS Azienda Ospedaliero-Universitaria di Bologna

TrialRECRUITING
Feb 2023Prospective Analysis of the Treatment of Progressive Familial Intrahepatic Cholestasis (TreatFIC)

University Medical Center Groningen

TrialRECRUITING
Jan 2017NAtural Course and Prognosis of PFIC and Effect of Biliary Diversion

University Medical Center Groningen

TrialENROLLING BY INVITATION

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

Treatments

No FDA-approved treatments are currently listed for Familial intrahepatic cholestasis.

5 clinical trialsare actively recruiting — trials can provide access to cutting-edge therapies.

View clinical trials →

Clinical Trials

5 recruitingView all trials with filters →
Other5 trials
Prospective Analysis of the Treatment of Progressive Familial Intrahepatic Cholestasis (TreatFIC)
Actively Recruiting
· Sites: Groningen
A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in South Korea
Actively Recruiting
PI: Ipsen Medical Director (Ipsen) · Sites: Seoul; Seoul
Familial Intrahepatic Cholestasis-related Genes Associated with Disease Susceptibility in Hepato-biliary Cancers
Actively Recruiting
PI: Giovanni Vitale, MD (IRCCS Azienda Ospedaliero-Universitaria di Bologna) · Sites: Bologna, Bologna; Bologna, Bologna +3 more
NAtural Course and Prognosis of PFIC and Effect of Biliary Diversion
Enrolling by Invitation
· Sites: Groningen, Provincie Groningen · Age: 065 yrs
A Study to Assess the Genetic Variations in Bile Flow Disorders: Linking Progressive Familial Intrahepatic Cholestasis (PFIC)-Related Genes to Symptoms in Adults With Recurrent Cholestasis in Spain
Actively Recruiting
PI: Ipsen Medical Director (Ipsen) · Sites: Barcelona; Barcelona +8 more · Age: 1899 yrs

Specialists

4 foundView all specialists →
GM
Giovanni Vitale, MD
DEARBORN, MI
Specialist
PI on 2 active trials1 Familial intrahepatic cholestasis publication
RM
Robert H Squires, MD
JACKSONVILLE, FL
Specialist
PI on 2 active trials
BD
Bikrant B Lal, MD, DM
Specialist
PI on 1 active trial
AS
Ahmad M Sira
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 Familial intrahepatic cholestasis.

Search all travel grants →NORD Financial Assistance ↗

Community

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Latest news about Familial intrahepatic cholestasis

Disease timeline:

New recruiting trial: A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in South Korea

A new clinical trial is recruiting patients for Familial intrahepatic cholestasis

New recruiting trial: Prospective Analysis of the Treatment of Progressive Familial Intrahepatic Cholestasis (TreatFIC)

A new clinical trial is recruiting patients for Familial intrahepatic cholestasis

New recruiting trial: Familial Intrahepatic Cholestasis-related Genes Associated with Disease Susceptibility in Hepato-biliary Cancers

A new clinical trial is recruiting patients for Familial intrahepatic cholestasis

New recruiting trial: DEFINING THE GENETIC DRIVERS OF ADULT-ONSET CHOLESTATIC LIVER DISEASE

A new clinical trial is recruiting patients for Familial intrahepatic cholestasis

New recruiting trial: A Study to Assess the Genetic Variations in Bile Flow Disorders: Linking Progressive Familial Intrahepatic Cholestasis (PFIC)-Related Genes to Symptoms in Adults With Recurrent Cholestasis in Spain

A new clinical trial is recruiting patients for Familial intrahepatic cholestasis

Caregiver Resources

NORD Caregiver Resources

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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.Which subtype of familial intrahepatic cholestasis does my child have, and what does that mean for their outlook?,Should we do genetic testing for other family members, including siblings?,Is my child a candidate for odevixibat or maralixibat, and what are the expected benefits and side effects?,At what point would you recommend a biliary diversion surgery or a liver transplant?,What vitamins and dietary changes does my child need, and how do we monitor for deficiencies?,Are there clinical trials or new treatments we should consider?,What signs should prompt me to go to the emergency room immediately?

Common questions about Familial intrahepatic cholestasis

What is Familial intrahepatic cholestasis?

Familial intrahepatic cholestasis (FIC) is a group of inherited liver diseases where bile — a digestive fluid made by the liver — cannot flow properly out of liver cells. When bile builds up inside the liver, it causes damage over time and leads to a range of symptoms. The condition is sometimes called progressive familial intrahepatic cholestasis, or PFIC, and it covers several subtypes caused by different gene changes. The most well-known subtypes are PFIC1, PFIC2, and PFIC3, each caused by a fault in a different gene. The main symptoms include severe, persistent itching (called pruritus),

How is Familial intrahepatic cholestasis inherited?

Familial intrahepatic cholestasis follows a autosomal recessive inheritance pattern. Genetic counseling can help families understand recurrence risk and testing options.

At what age does Familial intrahepatic cholestasis typically begin?

Typical onset of Familial intrahepatic cholestasis is infantile. Age of onset can vary across affected individuals.

Are there clinical trials for Familial intrahepatic cholestasis?

Yes — 5 recruiting clinical trials are currently listed for Familial intrahepatic cholestasis on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.

Which specialists treat Familial intrahepatic cholestasis?

4 specialists and care centers treating Familial intrahepatic cholestasis are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.