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Vancomycin in Primary Sclerosing Cholangitis in Italy (VanC-IT)

Primary Purpose

Primary Sclerosing Cholangitis, Liver and Intrahepatic Bile Duct Disorder, IBD

Status
Recruiting
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Oral Vancomycin
Placebo
Sponsored by
University of Milano Bicocca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Sclerosing Cholangitis focused on measuring liver, oral vancomycin, primary sclerosing cholangitis, Inflammatory bowel disease

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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; Absence of biliary obstruction and/or malignancy within 6-12 months of entry into the study; If a patient is on ursodeoxycholic acid (UDCA) or 5-aminosalicylic acid he or she is expected to remain on the same daily dose during the study period; Patients who received antibiotics or probiotics may participate if they had a washout period of at least 3-month prior to study entry; If a patient has been on obeticholic acid or other experimental therapies (e.g. cilofexor and norUDCA) for PSC, they must complete a 3-month washout period before study entry; PSC with or without IBD. IBD diagnosis should be documented and with a minimum disease duration of 6 months, as determined by endoscopic and histopathology assessment. IBD should be in clinical remission or mildly active according to CDAI and partial Mayo score for CD and UC, respectively (i.e. patients with CDAI score < 220 and pMayo score <5). Patients without documented IBD need a colonoscopy with segmental biopsies within 12 months prior to baseline visit; Female subjects of childbearing potential must test negative for pregnancy at screening, baseline and follow-up visits and if engage in sexual intercourse must agree to use specific methods of contraception. Male subjects with female partners of childbearing potential must use condoms during treatment and until the end of relevant systemic exposure. Exclusion Criteria: 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; Alcohol abuse (defined as greater than 14 standard drinks units per week in men; greater than 7 standard drinks units per week); Pregnancy and lactation; Advanced renal disease (GFR< 70); Active hepatitis B and/or C infection; Other chronic or cholestatic liver diseases such as PBC, autoimmune hepatitis, nonalcoholic steatohepatitis, alcoholic liver disease, Wilson's disease, hemochromatosis, α-1 antitrypsin deficiency, IgG4-related sclerosing cholangitis, and liver cancer; History of CCA; Advanced liver disease (history of variceal bleeding, ascites, hepatic encephalopathy, and/or bilirubine >4 mg/dL); On active transplantation list; IBD with uncontrolled moderate to severe activity; Active treatment or within the previous four weeks (washout period) with any immunosuppressive medication for controlling IBD (i.e. azathioprine, 6-mercaptopurine, tacrolimus, methotrexate, infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, ozanimod). Treatment with corticosteroids (including budesonide, budesonide MMX and beclomethasone) in the previous four weeks Active treatment with rifampicin or within the previous three months (washout period); Dose change within last 3 months prior to baseline of concomitant treatment with vitamin D or fibrates; Treatment with any experimental drug within the previous three months; Any known relevant infectious disease (e.g. active tuberculosis, AIDS defining disease); History or active hearing problems; Any active malignant disease; Well found doubt about patient's cooperation, e.g. addiction to alcohol or drugs; Imprisoned person, person admitted to nursing homes, persons under legal guardianship, and persons not able to express their consent.

Sites / Locations

  • Fondazione IRCCS San Gerardo dei TintoriRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Oral Vancomycin 750

Oral Vancomycin 1500

Placebo

Arm Description

28 subjects with PSC will be randomized to this arm. They will take 2 tablet (1 of vancomycin 250 mg and 1 of placebo), three times a day administered orally (total dose 750 mg/daily).

28 subjects with PSC will be randomized to this arm.They will take 2 tablet of 250 mg of vancomycin three times a day administered orally (total dose 1500mg/daily)

28 subjects with PSC will be randomized to this arm. They will take 2 tablet (placebo-to-match oral vancomycin) administered orally three times a day.

Outcomes

Primary Outcome Measures

Change from baseline in alkaline phosphatase (ALP) levels
ALP levels at 6 months

Secondary Outcome Measures

Safety and tolerability of OV in each treatment arm
Adverse events
Clinical hematology
White blood cells (10^3/uL)
Clinical hematology
Hemoglobin (g/dl)
Clinical hematology
Hematocrit (%)
Clinical hematology
MCV (Mean Corpuscular Volume) (fL)
Clinical hematology
Platelets (10^3/uL)
Clinical hematology
Absolute neutrophils (10^3/uL)
Clinical hematology
Absolute lymphocytes (10^3/uL)
Clinical hematology
PT (Prothrombin Time, Ratio)
Clinical hematology
INR
Clinical chemistry
Total proteins (g/dl)
Clinical chemistry
Albumin (g/dl)
Clinical chemistry
Gamma (g/dl)
Clinical chemistry
Sodium (mmol/l)
Clinical chemistry
Creatinine (mg/dl)
Clinical chemistry
Potassium (mmol/l)
Clinical chemistry
Urea (mg/dl)
Clinical chemistry
Glucose (mg/dl)
Clinical chemistry
Total bilirubin (mg/dl)
Clinical chemistry
Direct bilirubin (mg/dl)
Clinical chemistry
GGT (U/l)
Clinical chemistry
AST (U/l)
Clinical chemistry
ALT (U/l)
Clinical chemistry
Triglycerides (mg/dl)
Clinical chemistry
Cholesterol (Total) (mg/dl)
Clinical chemistry
High Density Lipoprotein (HDL Cholesterol) (mg/dl)
Clinical chemistry
PCR (C Reactive Protein) (mg/dl)
Clinical chemistry
IgG (mg/dl)
Clinical chemistry
IgA (mg/dl)
Clinical chemistry
IgM (mg/dl)
Clinical chemistry
Ferritin (ng/ml)
Single 12-lead electrocardiograms
Sinus rhythm
Single 12-lead electrocardiograms
QTc (msec)
Urine analysis
pH
Urine analysis
Specific gravity
Urine analysis
Hemoglobin
Urine analysis
ACR (mg/g)
Urine analysis
PCR (mg/g)
Vital sign measurements
Body weight (kg)
Vital sign measurements
Systolic blood pressure (mmHg)
Vital sign measurements
Diastolic blood pressure (mmHg)
Vital sign measurements
Heart Rate (bpm)
Vital sign measurements
Temperature (°C)
Changes in the PSC score
Revised Mayo Risk Score (Calculation formula = 0.03 (age [y]) + 0.54 loge (bilirubin [mg/dL]) + 0.54 loge (aspartate aminotransferase [U/L]) + 1.24 (variceal bleeding [0/1]) - 0.84 (albumin [g/dL]) (Higher scores indicate greater disease severity)
Changes in the IBD score
Clinical Mayo Score (Partial Mayo Score) -(0-1=Remission; 2-4 = Mild activity; 5-7 = Moderate activity; 7-9 = Severe activity)
Liver stiffness measurements
Stiffness (kPa/s)
Liver stiffness measurements
Stiffness IQR/median (%)
Liver stiffness measurements
CAP (dB/m)
Liver stiffness measurements
CAP IQR/median (%)
MRCP (Magnetic Resonance Cholangiopancreatography)
Disease localisation
MRCP (Magnetic Resonance Cholangiopancreatography)
Presence of dominant stenosis
MRCP (Magnetic Resonance Cholangiopancreatography)
Radiological signs of cirrhosis
Cytokines changes
TGF-β levels
Cytokines changes
IL-4 levels
Cytokines changes
IL-13 levels
Cytokines changes
IL-10 levels
Changes in the peripheral blood mononuclear cells
Th1 and Th17 subsets isolation and analyses
Patients quality of life
Visual analogue scale (VAS) score for itch
Patients quality of life
Chronic Liver Disease Questionnaire (CLDQ)
Patients quality of life
EQ-5D-5L questionnaire
Patients quality of life
PSC patient reported outcome (PSC-PRO) questionnaire
Patients quality of life
Inflammatory Bowel Disease Questionnaire (IBDQ)

Full Information

First Posted
March 10, 2023
Last Updated
June 29, 2023
Sponsor
University of Milano Bicocca
Collaborators
Genetic s.p.a.
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1. Study Identification

Unique Protocol Identification Number
NCT05876182
Brief Title
Vancomycin in Primary Sclerosing Cholangitis in Italy
Acronym
VanC-IT
Official Title
A Prospective, Randomized, Placebo-controlled Clinical Trial of Oral Vancomycin in Adults and Young Adults (15-17 Years Old) Affected by Primary Sclerosing Cholangitis With or Without Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Milano Bicocca
Collaborators
Genetic s.p.a.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
Primary sclerosing cholangitis (PSC) is chronic fibroinflammatory disease of the liver characterized by chronic inflammation and sclerosis of the intrahepatic and/or extrahepatic bile ducts, and a risk for progression to liver failure and development of colorectal and hepatobiliary cancer. Both children and adults are affected. Patients with PSC have a diminished life expectancy with a median survival of 17 years after diagnosis. Despite the high mortality associated with PSC and the efforts to optimize its management, there is no medical therapy proven to halt the progression of PSC or prevent its serious complications. There is a strong yet poorly understood relationship between PSC and inflammatory bowel disease (IBD); nearly 70%-80% of PSC patients have IBD, mainly ulcerative colitis (UC). Increasing evidence is pointing out the role of gut microbiota in the pathogenesis of PSC. The 'leaky gut' theory implies that either bacteria or their toxic metabolites translocate from the inflamed intestinal mucosa into the portal circulation and into the liver causing liver and biliary injury. The gut microbiota of PSC patients, compared to IBD patients and healthy controls, showed decreased microbial diversity, and over-represented intestinal pathobionts (i.e., organisms which, under normal circumstances, lives as a non-harming symbiont). Several antibiotics, including vancomycin and metronidazole, have been investigated in PSC. The use of oral vancomycin (OV), a glycopeptide antibiotic has been reported to be associated with improvement in clinical symptoms and laboratory abnormalities in patients with PSC; however, prospective studies in adult and young adult patients in Europe are lacking. Our scientific community therefore seeks to examine the safety and efficacy of OV in patients with PSC in a randomized placebo-controlled clinical trial. 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 with or without IBD. The study will consist of 10-week screening period (including a run-in phase), 24 weeks of treatment, and follow-up visits at 4 and 12 weeks after completion of treatment to evaluate what happens after treatment stop. Subjects will be randomized to placebo or treatment and stratifying by baseline presence of fibrosis by fibroscan value at baseline (< or ≥14.4 kPa corresponding to F4 fibrosis), as this parameter could affect the likelihood of reaching the primary composite outcome measure. The knowledge gained from our proposed clinical trial will help us determine if OV should be considered as a treatment option in patients with PSC. Furthermore, the use of state-of-the art technology applied in this study will shed light on the relationship between the gut microbiome, bile acids, immune-mediators, including cytokines, and PSC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sclerosing Cholangitis, Liver and Intrahepatic Bile Duct Disorder, IBD
Keywords
liver, oral vancomycin, primary sclerosing cholangitis, Inflammatory bowel disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Group A: vancomycin 750 mg daily Group B: vancomycin1500mg daily Group C: placebo
Masking
ParticipantInvestigator
Masking Description
During the randomization phase, subjects and all personnel directly involved in the conduct of the study will be blinded to the treatment assignment.
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral Vancomycin 750
Arm Type
Experimental
Arm Description
28 subjects with PSC will be randomized to this arm. They will take 2 tablet (1 of vancomycin 250 mg and 1 of placebo), three times a day administered orally (total dose 750 mg/daily).
Arm Title
Oral Vancomycin 1500
Arm Type
Experimental
Arm Description
28 subjects with PSC will be randomized to this arm.They will take 2 tablet of 250 mg of vancomycin three times a day administered orally (total dose 1500mg/daily)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
28 subjects with PSC will be randomized to this arm. They will take 2 tablet (placebo-to-match oral vancomycin) administered orally three times a day.
Intervention Type
Drug
Intervention Name(s)
Oral Vancomycin
Other Intervention Name(s)
OV
Intervention Description
The 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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The 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.
Primary Outcome Measure Information:
Title
Change from baseline in alkaline phosphatase (ALP) levels
Description
ALP levels at 6 months
Time Frame
From baseline to 6 months
Secondary Outcome Measure Information:
Title
Safety and tolerability of OV in each treatment arm
Description
Adverse events
Time Frame
From baseline to 6 months
Title
Clinical hematology
Description
White blood cells (10^3/uL)
Time Frame
From baseline to 6 months
Title
Clinical hematology
Description
Hemoglobin (g/dl)
Time Frame
From baseline to 6 months
Title
Clinical hematology
Description
Hematocrit (%)
Time Frame
From baseline to 6 months
Title
Clinical hematology
Description
MCV (Mean Corpuscular Volume) (fL)
Time Frame
From baseline to 6 months
Title
Clinical hematology
Description
Platelets (10^3/uL)
Time Frame
From baseline to 6 months
Title
Clinical hematology
Description
Absolute neutrophils (10^3/uL)
Time Frame
From baseline to 6 months
Title
Clinical hematology
Description
Absolute lymphocytes (10^3/uL)
Time Frame
From baseline to 6 months
Title
Clinical hematology
Description
PT (Prothrombin Time, Ratio)
Time Frame
From baseline to 6 months
Title
Clinical hematology
Description
INR
Time Frame
From baseline to 6 months
Title
Clinical chemistry
Description
Total proteins (g/dl)
Time Frame
From baseline to 6 months
Title
Clinical chemistry
Description
Albumin (g/dl)
Time Frame
From baseline to 6 months
Title
Clinical chemistry
Description
Gamma (g/dl)
Time Frame
From baseline to 6 months
Title
Clinical chemistry
Description
Sodium (mmol/l)
Time Frame
From baseline to 6 months
Title
Clinical chemistry
Description
Creatinine (mg/dl)
Time Frame
From baseline to 6 months
Title
Clinical chemistry
Description
Potassium (mmol/l)
Time Frame
From baseline to 6 months
Title
Clinical chemistry
Description
Urea (mg/dl)
Time Frame
From baseline to 6 months
Title
Clinical chemistry
Description
Glucose (mg/dl)
Time Frame
From baseline to 6 months
Title
Clinical chemistry
Description
Total bilirubin (mg/dl)
Time Frame
From baseline to 6 months
Title
Clinical chemistry
Description
Direct bilirubin (mg/dl)
Time Frame
From baseline to 6 months
Title
Clinical chemistry
Description
GGT (U/l)
Time Frame
From baseline to 6 months
Title
Clinical chemistry
Description
AST (U/l)
Time Frame
From baseline to 6 months
Title
Clinical chemistry
Description
ALT (U/l)
Time Frame
From baseline to 6 months
Title
Clinical chemistry
Description
Triglycerides (mg/dl)
Time Frame
From baseline to 6 months
Title
Clinical chemistry
Description
Cholesterol (Total) (mg/dl)
Time Frame
From baseline to 6 months
Title
Clinical chemistry
Description
High Density Lipoprotein (HDL Cholesterol) (mg/dl)
Time Frame
From baseline to 6 months
Title
Clinical chemistry
Description
PCR (C Reactive Protein) (mg/dl)
Time Frame
From baseline to 6 months
Title
Clinical chemistry
Description
IgG (mg/dl)
Time Frame
From baseline to 6 months
Title
Clinical chemistry
Description
IgA (mg/dl)
Time Frame
From baseline to 6 months
Title
Clinical chemistry
Description
IgM (mg/dl)
Time Frame
From baseline to 6 months
Title
Clinical chemistry
Description
Ferritin (ng/ml)
Time Frame
From baseline to 6 months
Title
Single 12-lead electrocardiograms
Description
Sinus rhythm
Time Frame
From baseline to 6 months
Title
Single 12-lead electrocardiograms
Description
QTc (msec)
Time Frame
From baseline to 6 months
Title
Urine analysis
Description
pH
Time Frame
From baseline to 6 months
Title
Urine analysis
Description
Specific gravity
Time Frame
From baseline to 6 months
Title
Urine analysis
Description
Hemoglobin
Time Frame
From baseline to 6 months
Title
Urine analysis
Description
ACR (mg/g)
Time Frame
From baseline to 6 months
Title
Urine analysis
Description
PCR (mg/g)
Time Frame
From baseline to 6 months
Title
Vital sign measurements
Description
Body weight (kg)
Time Frame
From baseline to 6 months
Title
Vital sign measurements
Description
Systolic blood pressure (mmHg)
Time Frame
From baseline to 6 months
Title
Vital sign measurements
Description
Diastolic blood pressure (mmHg)
Time Frame
From baseline to 6 months
Title
Vital sign measurements
Description
Heart Rate (bpm)
Time Frame
From baseline to 6 months
Title
Vital sign measurements
Description
Temperature (°C)
Time Frame
From baseline to 6 months
Title
Changes in the PSC score
Description
Revised Mayo Risk Score (Calculation formula = 0.03 (age [y]) + 0.54 loge (bilirubin [mg/dL]) + 0.54 loge (aspartate aminotransferase [U/L]) + 1.24 (variceal bleeding [0/1]) - 0.84 (albumin [g/dL]) (Higher scores indicate greater disease severity)
Time Frame
From baseline to 6 months
Title
Changes in the IBD score
Description
Clinical Mayo Score (Partial Mayo Score) -(0-1=Remission; 2-4 = Mild activity; 5-7 = Moderate activity; 7-9 = Severe activity)
Time Frame
From baseline to 6 months
Title
Liver stiffness measurements
Description
Stiffness (kPa/s)
Time Frame
From baseline to 6 months
Title
Liver stiffness measurements
Description
Stiffness IQR/median (%)
Time Frame
From baseline to 6 months
Title
Liver stiffness measurements
Description
CAP (dB/m)
Time Frame
From baseline to 6 months
Title
Liver stiffness measurements
Description
CAP IQR/median (%)
Time Frame
From baseline to 6 months
Title
MRCP (Magnetic Resonance Cholangiopancreatography)
Description
Disease localisation
Time Frame
From baseline to 6 months
Title
MRCP (Magnetic Resonance Cholangiopancreatography)
Description
Presence of dominant stenosis
Time Frame
From baseline to 6 months
Title
MRCP (Magnetic Resonance Cholangiopancreatography)
Description
Radiological signs of cirrhosis
Time Frame
From baseline to 6 months
Title
Cytokines changes
Description
TGF-β levels
Time Frame
From baseline to 6 months
Title
Cytokines changes
Description
IL-4 levels
Time Frame
From baseline to 6 months
Title
Cytokines changes
Description
IL-13 levels
Time Frame
From baseline to 6 months
Title
Cytokines changes
Description
IL-10 levels
Time Frame
From baseline to 6 months
Title
Changes in the peripheral blood mononuclear cells
Description
Th1 and Th17 subsets isolation and analyses
Time Frame
From baseline to 6 months
Title
Patients quality of life
Description
Visual analogue scale (VAS) score for itch
Time Frame
From baseline to 6 months
Title
Patients quality of life
Description
Chronic Liver Disease Questionnaire (CLDQ)
Time Frame
From baseline to 6 months
Title
Patients quality of life
Description
EQ-5D-5L questionnaire
Time Frame
From baseline to 6 months
Title
Patients quality of life
Description
PSC patient reported outcome (PSC-PRO) questionnaire
Time Frame
From baseline to 6 months
Title
Patients quality of life
Description
Inflammatory Bowel Disease Questionnaire (IBDQ)
Time Frame
From baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Absence of biliary obstruction and/or malignancy within 6-12 months of entry into the study; If a patient is on ursodeoxycholic acid (UDCA) or 5-aminosalicylic acid he or she is expected to remain on the same daily dose during the study period; Patients who received antibiotics or probiotics may participate if they had a washout period of at least 3-month prior to study entry; If a patient has been on obeticholic acid or other experimental therapies (e.g. cilofexor and norUDCA) for PSC, they must complete a 3-month washout period before study entry; PSC with or without IBD. IBD diagnosis should be documented and with a minimum disease duration of 6 months, as determined by endoscopic and histopathology assessment. IBD should be in clinical remission or mildly active according to CDAI and partial Mayo score for CD and UC, respectively (i.e. patients with CDAI score < 220 and pMayo score <5). Patients without documented IBD need a colonoscopy with segmental biopsies within 12 months prior to baseline visit; Female subjects of childbearing potential must test negative for pregnancy at screening, baseline and follow-up visits and if engage in sexual intercourse must agree to use specific methods of contraception. Male subjects with female partners of childbearing potential must use condoms during treatment and until the end of relevant systemic exposure. Exclusion Criteria: 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; Alcohol abuse (defined as greater than 14 standard drinks units per week in men; greater than 7 standard drinks units per week); Pregnancy and lactation; Advanced renal disease (GFR< 70); Active hepatitis B and/or C infection; Other chronic or cholestatic liver diseases such as PBC, autoimmune hepatitis, nonalcoholic steatohepatitis, alcoholic liver disease, Wilson's disease, hemochromatosis, α-1 antitrypsin deficiency, IgG4-related sclerosing cholangitis, and liver cancer; History of CCA; Advanced liver disease (history of variceal bleeding, ascites, hepatic encephalopathy, and/or bilirubine >4 mg/dL); On active transplantation list; IBD with uncontrolled moderate to severe activity; Active treatment or within the previous four weeks (washout period) with any immunosuppressive medication for controlling IBD (i.e. azathioprine, 6-mercaptopurine, tacrolimus, methotrexate, infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, ozanimod). Treatment with corticosteroids (including budesonide, budesonide MMX and beclomethasone) in the previous four weeks Active treatment with rifampicin or within the previous three months (washout period); Dose change within last 3 months prior to baseline of concomitant treatment with vitamin D or fibrates; Treatment with any experimental drug within the previous three months; Any known relevant infectious disease (e.g. active tuberculosis, AIDS defining disease); History or active hearing problems; Any active malignant disease; Well found doubt about patient's cooperation, e.g. addiction to alcohol or drugs; Imprisoned person, person admitted to nursing homes, persons under legal guardianship, and persons not able to express their consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Carbone, MD
Phone
0392334515
Email
marco.carbone@unimib.it
First Name & Middle Initial & Last Name or Official Title & Degree
Pietro Invernizzi, MD
Phone
039 233 2187
Email
pietro.invernizzi@unimib.it
Facility Information:
Facility Name
Fondazione IRCCS San Gerardo dei Tintori
City
Monza
State/Province
Monza E Brianza
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Carbone, MD
Phone
0392334515
Email
marco.carbone@unimib.it

12. IPD Sharing Statement

Plan to Share IPD
No

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Vancomycin in Primary Sclerosing Cholangitis in Italy

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