Trials Sponsors Conditions Drugs Pricing

Conditions

Intestinal Failure-associated Liver Disease

Keywords

Intestinal failure-associated liver disease (IFALD)IFALDLiver diseaseParenteral nutritionCholine deficiencyHepatic steatosisCholestasisparenteral nutrition-associated liver disease

Outcome Measures

Primary Outcomes (2)

Percentage of patients with choline deficiency
Choline deficiency is defined as plasma-free choline concentration less than 7 nmol/mL.
Day 1
Percentage of patients with choline deficiency, elevated serum ALP liver isoenzyme level and MRI-PDFF ≥8%
Choline deficiency is defined as plasma-free choline concentration less than 7 nmol/mL. Elevated serum ALP liver isoenzyme level is defined as \>1.5x upper limit of normal. MRI-PDFF ≥8 %
Day 1

Secondary Outcomes (3)

Percentage of patients with MRI-PDFF ≥8%
Day 1
Percentage of patients with elevated serum ALP liver isoenzyme level (defined as ≥ 1.5x upper limit of normal)
Day 1
Percentage of patients with abnormal liver tests including serum direct bilirubin, AST, ALT and GGT
Day 1

Eligibility Criteria

Age12 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

This study will enroll male and female adults and adolescent participants 12 years and older who are dependent on PN (≥ 4 days a week) in the primary care clinic setting.

You may qualify if:

The participant and/or their parent/Legally Authorized Representative is willing and able to provide signed informed consent or assent as appropriate

Sponsors & Collaborators

Protara Therapeutics
Industrylead

Study Sites (15)

Ronald Reagan Medical Center of UCLA

Los Angeles, California, 90095, United States

IHS Health

Kissimmee, Florida, 34741, United States

The University of Chicago

Chicago, Illinois, 60637, United States

Mayo Clinic

Rochester, Minnesota, 55905, United States

Duke University Medical Center

Durham, North Carolina, 27710, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

MeSH Terms

Conditions

Liver DiseasesHyperphagiaCholine DeficiencyFatty LiverCholestasis

Condition Hierarchy (Ancestors)

Digestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsVitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

Chief Scientific Operations Officer
Protara Therapeutics
STUDY DIRECTOR

Enrollment

80 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 11, 2021

First Posted

August 18, 2021

Study Start

August 23, 2021

Actual (reported)

Prevalence of Liver Disease in Patients Dependent on Parenteral Nutrition

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (15)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (15)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations