BridgeMD
New treatment option for Intestinal Failure Associated Liver Disease
Official title A Study of NST-6179 in Subjects With Intestinal Failure-Associated Liver Disease (IFALD).
ClinicalTrials.gov ID: NCT05919680
What this study is testing
What is NST-6179 Part A?
NST-6179 Part A is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for intestinal failure associated liver disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NST-6179 in subjects with intestinal failure-associated liver disease (IFALD) receiving parenteral nutrition (PN). The study will be conducted in 2 sequential parts.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- Adult persons aged 16 years or older at the time of informed consent.
- Minimum of 6 months on Parenteral supplementation.
- Established clinical diagnosis of IFALD based on a persistent elevation of
- liver enzymes (ALP, AST, ALT, or GGT ≥1.5 × upper limit of normal [ULN]) for ≥6 months and/or
- total bilirubin \> ULN for ≥6 months.
You likely can't join if
- Clinical, laboratory, imaging, or histopathologic evidence of other causes of acute or chronic liver disease, including autoimmune, viral, metabolic...
- Clinical evidence of compensated or decompensated hepatic cirrhosis as assessed by historical liver histology, ultrasound-based and/or signs and...
- Presence of hepatic impairment, end-stage liver disease, and/or a model for end-stage liver disease (MELD) score \>12.
- Transient elastography read \>20.0 kPA within 3 months prior to or during the Screening Period.
- Estimated glomerular filtration rate \<45 mL/min based on the 2021 CKD-EPI creatinine equation.
- Poor nutritional status defined as body mass index (BMI) \<17 kg/m2.
See the full eligibility criteria
- Adult persons aged 16 years or older at the time of informed consent.
- Minimum of 6 months on Parenteral supplementation.
- Established clinical diagnosis of IFALD based on a persistent elevation of
- liver enzymes (ALP, AST, ALT, or GGT ≥1.5 × upper limit of normal [ULN]) for ≥6 months and/or
- total bilirubin \> ULN for ≥6 months.
- Laboratory parameters consistent with stable liver disease without cirrhosis as defined by:
- ALT and AST \<5 × ULN;
- Total bilirubin ≤2.5 mg/dL in the absence of Gilbert's Syndrome.
- Serum albumin ≥2.5 g/dL;
- International normalized ratio (INR) ≤1.3 in the absence of anticoagulant therapy;
- Platelet count ≥120,000/mm3. Key
- Clinical, laboratory, imaging, or histopathologic evidence of other causes of acute or chronic liver disease, including autoimmune, viral, metabolic, or alcoholic liver disease.
- Clinical evidence of compensated or decompensated hepatic cirrhosis as assessed by historical liver histology, ultrasound-based and/or signs and symptoms of hepatic decompensation (including, but not limited to...
- Presence of hepatic impairment, end-stage liver disease, and/or a model for end-stage liver disease (MELD) score \>12.
- Transient elastography read \>20.0 kPA within 3 months prior to or during the Screening Period.
- Estimated glomerular filtration rate \<45 mL/min based on the 2021 CKD-EPI creatinine equation.
- Poor nutritional status defined as body mass index (BMI) \<17 kg/m2.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- San Francisco, California, United States
- Washington D.C., District of Columbia, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
- Seattle, Washington, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; San Francisco, California, United States; Washington D.C., District of Columbia, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.