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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Oral Vancomycin
DrugThe investigator will identify potential participants and confirm the diagnosis of PSC. Subjects will be screened within 10 weeks before randomization to determine the eligibility. Study participants will be consecutively randomized to oral vancomycin or placebo and investigational drug and placebo dispensed.
Placebo
Other interventionThe investigator will identify potential participants and confirm the diagnosis of PSC. Subjects will be screened within 10 weeks before randomization to determine the eligibility. Study participants will be consecutively randomized to oral vancomycin or placebo and investigational drug and placebo dispensed.
Treatment groups
84 Participants
are divided into 3 treatment groupsGroup A: Oral Vancomycin 750Experimental treatment 1 intervention
Group B: Oral Vancomycin 1500Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in alkaline phosphatase (ALP) levels
ALP levels at 6 months
Time frame
From baseline to 6 monthsSecondary outcomes
1
Safety and tolerability of OV in each treatment arm
Adverse events
Time frame
From baseline to 6 months2
Clinical hematology
White blood cells (10\^3/uL)
Time frame
From baseline to 6 months3
Clinical hematology
Hemoglobin (g/dl)
Time frame
From baseline to 6 months4
Clinical hematology
Hematocrit (%)
Time frame
From baseline to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Milano Bicocca
Lead sponsor
Genetic s.p.a.
Collaborator
Source ClinicalTrials.gov