Trial · NCT05426733
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia
NCT05426733, Phase 3, Active not recruiting, Albireo, an Ipsen Company
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia. Trials, record NCT05426733. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05426733
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia
- NCT number
- NCT05426733
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 180 participants, estimated
- Lead sponsor
- Albireo, an Ipsen Company
- Conditions
- Biliary Atresia
- Interventions
- Odevixibat
- First posted
- 2022-06-22
- Last updated
- 2026-10-23
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients who are alive and have not undergone liver transplant | From baseline to Week 104 | |
| Secondary | Change in aspartate aminotransferase (AST) to platelet ratio index (APRI) score | From baseline to Week 104 | The APRI (aspartate aminotransferase to platelet ratio index) score estimates the severity of liver fibrosis. A higher score indicates a greater amount of scarring (fibrosis) in the liver. * A score ≤ 0.5 indicates a low likelihood of fibrosis * A score ≥ 1.5 indicates a higher probability of fibrosis |
| Secondary | Change in Fibrosis-4 (Fib-4) score | From baseline to Week 104 | The Fib-4 score provides an estimate of the amount of scarring (fibrosis) in the liver. A higher score indicates a greater amount of scarring in the liver. * A score \< 1.45 indicates a low likelihood of fibrosis * A score \> 3.25 indicates a higher probability of fibrosis |
| Secondary | Change in serum bile acids | From Baseline to Weeks 26, 52, 78, and 104 | |
| Secondary | Change in height | From Baseline to Weeks 26, 52, 78 and 104 | |
| Secondary | Change in weight | From Baseline to Weeks 26, 52, 78 and 104 | |
| Secondary | Change in mid-arm circumference | From Baseline to Weeks 26, 52, 78 and 104 | Measure of growth |
| Secondary | Time to onset of any sentinel events | From Baseline to Week 104 | |
| Secondary | Change in pediatric end-stage liver disease (PELD) score | From Baseline to Weeks 26, 52, 78 and 104 | The PELD (pediatric end-stage liver disease) score is a measure of disease severity. PELD scores can range from a negative value (such as -10) to high numbers (such as 45). A higher score indicates more severe disease. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05426733
GET https://conductscience.org/api/trials/v1/NCT05426733/registered