Trial · NCT05035030
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| 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 |
| Secondary | Change from baseline in sleep parameters. | Baseline to week 72 (cohort 1). | Assessed with the Albireo ObsRO/PRO instruments (e.g: tiredness and number of awakenings). |
| Secondary | Change from baseline in Pediatric Quality of Life Inventory (PedsQL) scores. | Baseline to week 72 (cohort 1). | The PedsQL instrument consists of 36 questions and uses a 5-point response scales, where higher scores indicates worst symptoms. |
| Secondary | Change from baseline in in Global Symptom Relief: Patient Global Impression of Improvement (PGIC) score. | Baseline to Weeks 4, 12, 24, 48 and 72 (cohort 1). | The Patient Global Impression of Change (PGIC) is a patient-reported instrument that measures change in overall status on a scale ranging from one ("very much improved") to seven ("very much worse"). |
| Secondary | Change from baseline in in Global Symptom Relief: Clinical Global Impression of Improvement (CGIC) score. | Baseline to Weeks 4, 12, 24, 48 and 72 (cohort 1). | The Clinical Global Impression of Change (CGIC) is a clinician-reported instrument that measures change in overall status on a scale ranging from one ("very much improved") to seven ("very much worse"). |
| Secondary | Change from baseline in in Global Symptom Relief: Caregiver Global Impression of Change (CaGIC) score | Baseline to Weeks 4, 12, 24, 48 and 72 (cohort 1). | The caregiver Global Impression of Change is a caregiver-reported instrument that measures change in overall status on a scale ranging from one ("very much improved") to seven ("very much worse"). |
| Secondary | Change from baseline in serum bile acid levels. | Baseline through week 72 (cohort 1). | |
| Secondary | Percentage of participants with Treatment Emergent Adverse Event (TEAEs) and Serious Adverse Events (SAEs) | Baseline to week 72 (cohort 1). | 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 resultes 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. |
| Secondary | Number of participants with change from baseline in physical examination | Baseline to week 72 (cohort 1). | |
| Secondary | Number of participants with change from baseline in vital signs | Baseline to week 72 (cohort 1). | |
| Secondary | Change from baseline in concomitant medications | Baseline to week 72 (cohort 1). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT05035030/registered