Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01456468 · ClinicalTrials.gov registry record · Phase 1
Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis
A Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT01456468: Completed Phase 1 study, sponsored by Yale University.
NCT01456468 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01456468, a Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine whether the combination of UDCA and ATRA taken for 3 months will improve laboratory tests of liver and bile duct inflammation in patients with Primary Sclerosing Cholangitis (PSC). Our hypothesis is that a combination of these medications will improve the liver inflammatory tests in these patients, specifically a reduction in alkaline phosphatase (AP) by at least 30%.
Primary Outcome
The primary outcome measure is a 30% improvement in serum alkaline phosphatase in subjects, comparing pre- and post-treatment values for each individual.
Interventions
- DRUG Oral all-trans retinoic acid (ATRA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2011-10 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT01456468 record still lists
NCT01456468 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which Oral all-trans retinoic acid (ATRA) is the first listed.
NCT01456468 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01456468 about?
NCT01456468 is a clinical study titled "Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis". The purpose of this research study is to determine whether the combination of UDCA and ATRA taken for 3 months will improve laboratory tests of liver and bile duct inflammation in patients with Primary Sclerosing Cholangitis (PSC). Our hypothesis is that a combination of these medications will impro...
What is the current status of trial NCT01456468?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2011-10. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01456468?
The interventions under investigation include: Oral all-trans retinoic acid (ATRA) (DRUG).
Who is sponsoring clinical trial NCT01456468?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01456468's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03207464 · 19 participants · Phase 1
Molecular Imaging of NET Using [C-11]MRB-PET in MS
- NCT04318717 · 19 participants · Phase 2
Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma
- NCT05103904 · 19 participants · Phase 2
Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant
- NCT05607407 · 19 participants · Phase 2
Methimazole in Patients With Progressive Glioblastoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia