Trial · NCT05035030
Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome
NCT05035030, Phase 3, Active not recruiting, Albireo, an Ipsen Company
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome. Trials, record NCT05035030. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05035030
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome
- NCT number
- NCT05035030
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 62 participants, actual
- Lead sponsor
- Albireo, an Ipsen Company
- Conditions
- Alagille Syndrome
- Interventions
- Odevixibat
- First posted
- 2021-09-05
- Last updated
- 2026-10-23
- Other registries' IDs
- eudract:2021-000996-36
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in pruritus | Baseline to week 72 (cohort 1). | Assessed as change in scratching score as measured by measured by the Albireo Observer-Reported Outcome Caregiver Instrument. |
| Primary | Percentage of participants with Treatment Emergent Adverse Event (TEAEs) and Serious Adverse Events (SAEs) | Baseline to week 12 (cohort 2). | An Adverse event (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. A serious adverse event (SAE) is an AE that results in any of following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent adverse events. TEAEs included both Serious TEAEs and non-serious TEAEs. |
| Primary | Percentage of participants with clinically significant changes from baseline in Physical Examination | Baseline to week 12 (cohort 2). | The clinical significance will be graded by the investigator. |
| Primary | Percentage of participants with clinically significant changes in Laboratory Parameters | Baseline to week 12 (cohort 2). | The following laboratory parameters will be reported: blood chemistry, hematology and coagulation. The clinical significance will be graded by the investigator. |
| Primary | Percentage of participants with clinically significant changes from baseline in Vital Signs. | Baseline to week 12 (cohort 2). | The clinical significance will be graded by the investigator. |
| Primary | Change from baseline in concomitant medications. | Baseline to week 12 (cohort 2). | |
| Primary | Change from baseline in fat-soluble vitamin levels. | Baseline to week 12 (cohort 2). | |
| Secondary | Change from baseline in serum bile acids levels | Baseline to week 72 (cohort 1). | |
| Secondary | Change from baseline in patient reported and observer reported itching and scratching severity scores | Baseline to week 72 (cohort 1). | Assessed by the the Albireo ObsRO/ Patient Reported Outcomes (PRO) instruments. The Albireo ObsRO/PRO scratching and itch severity items use 0 to 4 response scales, where each response is distinguished by a unique facial expression, verbal anchor, number, and color code. |
| Secondary | Percentage of participants achieving a clinically meaningful decrease in pruritus (pruritus responders) | Baseline to week 72 (cohort 1). | Assessed by the Albireo ObsRO/patient reported outcomes (PRO) instruments |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes0
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/NCT05035030
GET https://conductscience.org/api/trials/v1/NCT05035030/registered?page=2