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New treatment option for Primary Sclerosing Cholangitis
Official title Vancomycin in Primary Sclerosing Cholangitis in Italy
ClinicalTrials.gov ID: NCT05876182
What this study is testing
What is Oral Vancomycin?
Oral Vancomycin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for primary sclerosing cholangitis.
Also referred to as OV.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 to 70
You may be able to join if
- Willing and able to give informed consent prior to any study specific procedure being performed;
- Male and non-pregnant, non-lactating female people, including women of child bearing potential (WOCBP), between 15-70 years of age at the time of...
- 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;
You likely can't join if
- 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...
- 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;
See the full eligibility criteria
- Willing and able to give informed consent prior to any study specific procedure being performed;
- Male and non-pregnant, non-lactating female people, 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...
- Female people 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 people with female partners of childbearing potential must use condoms during treatment and until the end of relevant systemic exposure.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Monza, Monza E Brianza, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Monza, Monza E Brianza, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.