Open pilot study of treatment with an antibiotic called vancomycin to children and adolescents with chronic inflammation of the bile ducts, called primary sclerosing cholangitis (PSC)

• Register: EUCTR
• Last refreshed on: 3 June 2013
• Main ID: EUCTR2009-018034-11-SE
• Date of registration: 21/06/2011
• Prospective Registration: Yes
• Primary sponsor: Karolinska Institutet
• Public title: Open pilot study of treatment with an antibiotic called vancomycin to children and adolescents with chronic inflammation of the bile ducts, called primary sclerosing cholangitis (PSC)
• Scientific title: Open pilot study of treatment with vancomycin to children and adolescents with primary sclerosing cholangitis - vanco-psc
• Date of first enrolment: 29/04/2013
• Target sample size: 20
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-018034-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Historical controls Number of treatment arms in the trial: 1

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
Children and adolescents > 1 year < 20 years who have MRC verified PSC and markers of disease which can easily be followed until normalisation:
- jaundice, itching and ascites
- increased liver function tests
- The initial liver biopsy consistent with PSC, not compulsory.
- Colonoscopy
The patients should be newly diagnosed or therapy resistant to commonly used therapy.


Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Known hypersensitivity towards vancomycin
Pregnancy
Chronic renal failure.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Primary Sclerosing Cholangitis (PSC) is a progressive disease of the biliary system which might lead to increased risk of cholangiocancer. PSC constitutes a common indication for adult liver transplantation (ltx). In 80% of cases PSC is associated with inflammatory bowel disease (IBD), while 3-5 % of patients with colonic IBD, suffer from the disease. The conservative treatment options are few. There is a relatively high risk of recurrency after ltx.

Intervention(s)

Trade Name: Vancomycin
Product Name: vancomycin
Pharmaceutical Form: Capsule

Trade Name: vancomycin
Product Name: Vancomycin
Pharmaceutical Form: Oral solution

Primary Outcome(s)

Primary end point(s): Clinical status of patients after 1 year
Improvement of symptoms after 1 year
Improvement of liver function tests after 1 year
Improvement of bile duct stenosis as measured by MRC after 1 year
Improvement of liver histology after 1 year

Secondary Objective: To study if oral vancomycin during 1 year may improve liver histology and magnetic resonance cholangiography (MRC)

Main Objective: To study if oral vancomycin during 1 year may improve liver- and gut function.

Timepoint(s) of evaluation of this end point: One year after treatment start

Secondary ID(s)

2010vanco.psc