Study for Biliary Atresia

(BASIC Trial)

Recruiting at 9 trial locations

Overseen By Melissa Sexton, BBA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Arbor Research Collaborative for Health

Disqualifiers: ChiLDReN study PROBE, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

1265 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather insights into biliary atresia, a liver condition affecting bile ducts, by collecting genetic material and body fluid samples. Researchers seek to identify the genes involved and understand how the condition progresses in children who have not undergone a liver transplant. The trial suits children and young adults up to age 20 living with biliary atresia and their native liver. Participants must be willing to provide samples and attend all scheduled visits. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to improved understanding and treatment options for biliary atresia.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on collecting body fluid and genetic material samples to better understand biliary atresia in infants and children. Unlike current treatments, which primarily involve surgical procedures like the Kasai procedure or liver transplantation, this approach aims to uncover the underlying genetic and biological factors of the condition. By identifying specific biomarkers, this trial could lead to more targeted and effective treatments in the future, potentially reducing the need for invasive surgeries.

Who Is on the Research Team?

Sanjiv Harpavat, MD

Principal Investigator

Texas Children's/Baylor College of Medicine

Katrina Loh, MD

Principal Investigator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Lisa Henn, PhD

Principal Investigator

Arbor Research Collaborative for Health - Data Coordinating Center

Ed Doo, MD

Principal Investigator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

John C Magee, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

Inclusion Criteria

Participants need to have a confirmed diagnosis of BA determined by chart review including review of pertinent diagnostic biopsy reports, radiologic reports and surgical reports (if surgery was performed).

Participants need to be >6 months of age up to and equal to the age of 20 (participants enrolled at 20 years of age will have one visit).

Participants either have their native liver or have a confirmed liver transplantation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Collection of clinical information, genetic material, and body fluid samples

1 visit

1 visit (in-person)

Observational Follow-up

Participants are monitored for natural history and disease progression

Yearly follow-up visits

Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Body Fluid Sample Collection
• Genetic Material Collection

Who Is Running the Clinical Trial?

Arbor Research Collaborative for Health

Lead Sponsor

Trials

21

Recruited

35,500+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+