Efficacy of Different Doses of Bezafibrate in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cholangitis
NCT07926087, Phase 4, Completed, Instituto de Biotecnologia de Misiones
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Efficacy of Different Doses of Bezafibrate in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cholangitis | ClinicalTrials.gov |
| NCT number | NCT07926087 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 60 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Instituto de Biotecnologia de Misiones | ClinicalTrials.gov |
| Conditions | Primary Biliary Cholangitis (PBC) | ClinicalTrials.gov |
| Interventions | UDCA 13-15 mg/kg/day, UDCA 13-15 mg/kg/day + Bezafibrate 400 mg/day, UDCA 13-15 mg/kg/day + Bezafibrate 800 mg/day | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Normalization of alkaline phosphatase (ALP) levels | 24 weeks | Evaluation of the proportion of patient who achieve normal values in the cholestatic marker ALP | ClinicalTrials.gov |
| Secondary | Biochemical Response Rate | Week 24 | Proportion of patients achieving normalization of biochemical markers including GGT, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Total Bilirubin. | ClinicalTrials.gov |
| Secondary | Deep response rate | 24 weeks | Proportion of patients achieving normalization of biochemical markers ALP and Total Bilirubin below 0.6 mg/dL. | ClinicalTrials.gov |
| Secondary | Change in Serum Alkaline Phosphatase (ALP) Levels | Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Evaluation of the reduction in cholestatic marker ALP from baseline | ClinicalTrials.gov |
| Secondary | Change in Pruritus Severity (Visual Analog Scale) | 24 weeks | Pruritus assessed using a Visual Analog Scale (VAS). The scale ranges from 0 to 10 cm, where 0 represents "no itching" and 10 represents "worst itching imaginable". Lower scores indicate a better outcome. | ClinicalTrials.gov |
| Secondary | Incidence of Treatment-Emergent Adverse Events | Baseline and every 4 weeks up to Week 24 | Incidence of treatment-emergent adverse events, including muscle pain (myopathy) and renal function changes (Creatinine, Urea). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)