NCT05919433 Detection Program for Patients With Primary Biliary Cholangitis Lost in the System
| NCT ID | NCT05919433 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Mutua de Terrassa |
| Condition | Primary Biliary Cholangitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2023-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2023-05-01 with a primary completion date of 2023-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Primary biliary cholangitis (PBC) has been considered a rare disease and its management has been limited by the lack of therapeutic alternatives. PBC is a slowly progressing chronic liver disease characterized by an immune-mediated destruction of the intrahepatic bile ducts, which leads to cholestasis, portal inflammation, and ultimately liver cirrhosis and its associated complications (ascites, portal hypertension, etc), if not treated effectively. Thus, early diagnosis and close management of these patients with PBC is essential. First-line treatment with ursodeoxycholic acid (UDCA) improves liver biochemical parameters, delays histological progression, and increases liver transplant-free survival and overall survival. However, up to 40% of patients are non-responders to UDCA. Obeticholic acid (OCA) is recommended as second-line therapy in combination with UDCA for patients with an inadequate response to UDCA or as monotherapy in cases of UDCA intolerance. According to current clinical guidelines, the diagnosis of PBC includes a combination of elevated alkaline phosphatase (ALP) levels and the presence of anti-mitochondrial antibodies (AMA) (titer \>1:40) and/or anti-nuclear antibodies (ANA) anti-gp210 or anti-sp100. AMA are highly sensitive and specific for PBC and are detected in nearly 95% of PBC patients. A liver biopsy is not necessary unless there is an elevation of ALP without the presence of specific AMA and/or anti-gp210 or anti-sp100 ANA or if coexistence with other liver diseases is suspected (autoimmune hepatitis, hepatic steatosis). The incidence of PBC has increased in recent years due to an increase in the diagnosis of cases in the initial phases, better awareness in the medical community and the development of more sensitive diagnostic tests. However, up to 31% of patients with PBC are lost without follow-up. The correct identification of patients with PBC is essential so that they can benefit from an adequate treatment and modify disease progression. To date, two studies (one Spanish and one Portuguese) showed that 27% and 45.5% of the patients lost with PBC presented advanced fibrosis, respectively. The objective of this study is to identify, through computerized data, patients with PBC who may be lost in the system and evaluate their clinical, analytical and demographic characteristics, and in a second phase, provide access to follow-up in specialized consultations.
Eligibility Criteria
Inclusion Criteria: * Patients with positive AMA and/or with positive ANA anti-gp210 or anti-sp100 identified in the computer databases of each of the participating centers. * Adults (≥18 years) Exclusion Criteria: * Patients with Overlap Syndrome (PBC overlap with Autoimmune Hepatitis (AIH))
Contact & Investigator
Diana Horta, MD, PhD
✉ diana.horta.s@gmail.comFrequently Asked Questions
Who can join the NCT05919433 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Biliary Cholangitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05919433 currently recruiting?
Yes, NCT05919433 is actively recruiting participants. Contact the research team at diana.horta.s@gmail.com for enrollment information.
Where is the NCT05919433 trial being conducted?
This trial is being conducted at Terrassa, Spain.
Who is sponsoring the NCT05919433 clinical trial?
NCT05919433 is sponsored by Hospital Mutua de Terrassa. The trial plans to enroll 500 participants.