Trial · NCT04336722
Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)
NCT04336722, Phase 3, Completed, Albireo, an Ipsen Company
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD). Trials, record NCT04336722. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04336722
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)
- NCT number
- NCT04336722
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 254 participants, actual
- Lead sponsor
- Albireo, an Ipsen Company
- Conditions
- Biliary Atresia
- Interventions
- Odevixibat, Placebo
- First posted
- 2020-04-07
- Last updated
- 2026-07-02
- Other registries' IDs
- eudract:2019-003807-37
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time from randomization to first occurrence of liver transplant, or death | From baseline to Week 104 | |
| Secondary | Proportion of patients with liver transplant | From baseline to Week 104 | Proportion of patients who are alive and have not undergone a liver transplant |
| Secondary | Time to onset of any sentinel events | From baseline to Week 104 | Time to onset of any sentinel events |
| Secondary | Total bilirubin levels | From baseline to Weeks 13, 26, 52 and 104 | Total bilirubin level after 13, 26, 52, and 104 weeks of study treatment |
| Secondary | Serum bile acid levels | From baseline to Weeks 13, 26, 52 and 104 | Serum bile acid level after 13, 26, 52, and 104 weeks of study treatment |
| Secondary | Time to pediatric end-stage liver disease (PELD) score >15 | From baseline to Week 104 | Time to pediatric end-stage liver disease (PELD) score \>15 |
| Secondary | Percentage of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | From baseline to Week 104 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Secondary | Percentage of participants with clinically significant changes in Physical Examination | From baseline to Week 104 | Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be graded by the investigator. |
| Secondary | Percentage of participants with clinically significant changes in Laboratory Parameters (blood chemistry, hematology and coagulation) | From baseline to Week 104 | Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will be decided by the investigator. |
| Secondary | Percentage of participants with clinically significant changes in Abdominal Ultrasound findings | From baseline to Week 26 and Week 104 | Percentage of participants with clinically significant change in Abdominal Ultrasound findings will be reported. The clinical significance will be decided by the investigator. |
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/NCT04336722
GET https://conductscience.org/api/trials/v1/NCT04336722/registered