Vancomycin in Primary Sclerosing Cholangitis in Italy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age15-70
SponsorUniversity of Milano Bicocca
About this trial
Primary sclerosing cholangitis (PSC) is chronic fibroinflammatory disease of the liver. There is still no medical therapy proven to halt the progression of PSC or prevent its serious complications.
This is a Phase 2 randomized, double bind, placebo-controlled, monocentric study evaluating the safety and efficacy of two doses of oral vancomycin (i.e. 750 mg and 1500 mg/day) in subject between 15 - 70 years old with PSC.
Eligibility criteria
Qualifiers
Willing and able to give informed consent prior to any study specific procedure being performed;
Male and non-pregnant, non-lactating female subjects, including women of child bearing potential (WOCBP), between 15-70 years of age at the time of informed consent;
Diagnosis of large-duct PSC based on cholangiogram (at MRCP, ERCP, PTC) according to the most recent published guidelines (EASL);
Baseline ALP ≥1.5 times upper limit normal at screening;
Disqualifiers
Receiving an antibiotic or probiotic within 3 months prior to the study;
Expected to receive antibiotics within the weeks leading up to enrollment (such as patients with recurrent cholangitis, ongoing infectious illnesses, etc.);
Allergy to vancomycin or teicoplanin;
Biliary intervention within 3 months prior to study enrollment or planned;
Trial design
Treatments tested in this trial
- Oral Vancomycin
- Placebo
Treatment groups
84 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Milano Bicocca
Lead sponsor
Genetic s.p.a.
Collaborator
Source ClinicalTrials.gov