An observational study in Primary Biliary Cholangitis, sponsored by Hospital Mutua de Terrassa. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-26.
Sponsored by Hospital Mutua de Terrassa · Observational
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Among 32 studies in Liver Cirrhosis, Biliary with a site in Spain — 7 open to participants now, 13 under way, 5 of them phase 3. Liver Cirrhosis, Biliary · Spain.
Among the 32 studies in Liver Cirrhosis, Biliary with a site in Spain, this one is one of 4 that started in 2023, is one of 6 observational ones, reaches primary completion later than 1 of the 12 other live ones, and was the 21st registered.
214 studies on the registry are indexed under Liver Cirrhosis, Biliary; 48 are open to participants now.
Browse Liver Cirrhosis, Biliary studies →7 of the 32 studies in Liver Cirrhosis, Biliary with a site in Spain are open now. Recruiting first, the newest first:
Hospital Universitario La Paz · Sites in Spain
Ages 18–80
Hospital Clinic of Barcelona · Sites in Spain
Ages 18–80 · Healthy volunteers
Assistance Publique - Hôpitaux de Paris · Sites in Spain, Austria, Belgium and 4 more countries
Ages 18–70
Gilead Sciences · Sites in Spain, United States, Argentina and 26 more countries
Ages 18+
Ipsen · Sites in Spain, United States, Argentina and 25 more countries
Ages 18+
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 34 Liver Cirrhosis, Biliary studies recruiting now, 16 (47%) set no upper age limit and 11 (32%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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32 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 11 · Phase 3 11 · Phase 4 2
First in 2007; this study’s year is marked. 4 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 500 is above the median of 380 across 54 observational studies indexed under Liver Cirrhosis, Biliary.
Median enrollment 129 across the 26 interventional studies, 1,750 across the 6 observational. Of the 18 that completed or were terminated, 16 (89%) have results posted.
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25 of 32 have an industry lead sponsor. The 10 most frequent:
Hospital Mutua de Terrassa is the lead sponsor of 35 studies on the registry; 12 are open to participants now.
Hospital Mutua de Terrassa has 1 study filed under Liver Cirrhosis, Biliary — fewer than ten, so there is no comparison to draw.
2 of the studies in Liver Cirrhosis, Biliary with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05050136Mirum Pharmaceuticals, Inc.A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis | 2027-01 |
| NCT07821463Fundacio Privada Mon Clinic BarcelonaEpidemiology of PrImary Biliary Cholangitis in Spain | 2027-08 |
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Among the 32 studies in Liver Cirrhosis, Biliary with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Patients identified in the database of the participating hospitals
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Percentage of patients correctly diagnosed with PBC and monitored in specialized health care compared to lost to follow-up PBC patients
Time frame: at inclusion
Started May 2023 (actual). Primary completion is estimated for Dec 2023, 7 months after the start.
How these figures are worked out, and which studies are left out of them.
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Hospital Mutua de Terrassa