NCT00345553 Biliary Atresia Study in Infants and Children
| NCT ID | NCT00345553 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Arbor Research Collaborative for Health |
| Condition | Biliary Atresia |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,265 participants |
| Start Date | 2006-05-16 |
| Primary Completion | 2029-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,265 participants in total. It began in 2006-05-16 with a primary completion date of 2029-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Little is known about the factors that cause biliary atresia nor the factors that influence disease progression. The purpose of this study is to collect the pertinent clinical information, genetic material and body fluid samples to enable investigators to address the following aims: To identify the gene or genes implicated in the etiology of BA; To characterize the natural history of the older, non-transplanted child with BA.
Eligibility Criteria
Inclusion Criteria: 1. 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). 2. 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). 3. Participants with their native liver. 4. Parent, guardian or participant (if 18 years of age or older) is willing to provide informed consent and, when appropriate, the participant is willing to assent. Exclusion Criteria: 1. Currently participating in the ChiLDReN study PROBE. 2. Inability to confirm original diagnostic evaluation of biliary atresia. 3. Inability or unwillingness of family or participant to participate in all scheduled visits. 4. History of liver transplantation.
Contact & Investigator
Sanjiv Harpavat, MD
STUDY CHAIR
Texas Children's/Baylor College of Medicine
Frequently Asked Questions
Who can join the NCT00345553 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 20 Years, studying Biliary Atresia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00345553 currently recruiting?
Yes, NCT00345553 is actively recruiting participants. Contact the research team at melissa.sexton@arborresearch.org for enrollment information.
Where is the NCT00345553 trial being conducted?
This trial is being conducted at Los Angeles, United States, San Francisco, United States, Aurora, United States, Atlanta, United States and 11 additional locations.
Who is sponsoring the NCT00345553 clinical trial?
NCT00345553 is sponsored by Arbor Research Collaborative for Health. The principal investigator is Sanjiv Harpavat, MD at Texas Children's/Baylor College of Medicine. The trial plans to enroll 1,265 participants.