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Pyridoxine in primary sclerosing cholangitis
EU CTIS ID: 2023-505155-47-00
What this study is testing
To show the superiority of pyridoxine compared to placebo in the treatment of PSC as assessed by reduction of alkaline phosphatase levels
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant must be > 18 years of age and < 75 years of age at the time of signing the informed consent.
- Capable of responding to patient questionnaires
- Must be able to understand Norwegian
- Participants with a confirmed diagnosis of large-duct PSC, verified by retrograde, operative, percutaneous or magnetic resonance cholangiography demonstrating intrahepatic and/or extrahepatic biliary duct changes such as beading or narrowing consistent with PSC.
- Alkaline phosphatase > upper limit of normal reference (105 U/L) at screening.
- All patients must have been investigated by colonoscopy at least once. Patients with concomitant IBD must have colonoscopy available within the last 24 months prior to screening.
You likely can't join if
- History or presence of other competing liver diseases including a. Positive hepatitis B or C serology b. Primary biliary cholangitis c. Wilson’ disease d. Hemochromatosis e. Biopsy verified non-alcoholic steatohepatitis (NASH) f. Cholangiocarcinoma g. Chronic alcohol consumption defined as a daily consumption of 3 units/day (36 gr/d) for males and 2 units/day (24gr/day) for females h. α1-antitrypsin deficiency i. congenital biliary disease
- Secondary causes of sclerosing cholangitis such as iatrogenic bile duct injury, IgG4- associated cholangitis, sepsis, and burns.
- Small duct cholangitis in the absence of large duct disease.
- Liver cirrhosis with a Child-Pugh B or C classification as defined by; history of variceal bleeding, hepatic encephalopathy, or resistant ascites.
- History of bacterial cholangitis with hospitalization within 12 weeks prior to screening.
- Colectomy or any other colorectal resections.
See the full eligibility criteria
Who can join
- Participant must be > 18 years of age and < 75 years of age at the time of signing the informed consent.
- Capable of responding to patient questionnaires
- Must be able to understand Norwegian
- Participants with a confirmed diagnosis of large-duct PSC, verified by retrograde, operative, percutaneous or magnetic resonance cholangiography demonstrating intrahepatic and/or extrahepatic biliary duct changes such as beading or narrowing consistent with PSC.
- Alkaline phosphatase > upper limit of normal reference (105 U/L) at screening.
- All patients must have been investigated by colonoscopy at least once. Patients with concomitant IBD must have colonoscopy available within the last 24 months prior to screening.
- If concomitant IBD, any colitis should be in remission or show mild activity over 12 weeks prior to screening.
- Participants on treatment with biologics, immunosuppressives or corticosteroids must be taking a stable dose for at least 12 weeks prior to screening and expected to remain on the same medication for the duration of the study.
- Participants with ursodeoxycholic acid or bezafibrate treatment on a stable dose for at least 12 weeks prior to screening
- If concomitant autoimmune hepatitis, a stable dose of immunosuppression over the last 12 months is required (e.g., prednisone, budesonide, azathioprine).
- Capable of giving written informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
What rules you out
- History or presence of other competing liver diseases including a. Positive hepatitis B or C serology b. Primary biliary cholangitis c. Wilson’ disease d. Hemochromatosis e. Biopsy verified non-alcoholic steatohepatitis (NASH) f. Cholangiocarcinoma g. Chronic alcohol consumption defined as a daily consumption of 3 units/day (36 gr/d) for males and 2 units/day (24gr/day) for females h. α1-antitrypsin deficiency i. congenital biliary disease
- Secondary causes of sclerosing cholangitis such as iatrogenic bile duct injury, IgG4- associated cholangitis, sepsis, and burns.
- Small duct cholangitis in the absence of large duct disease.
- Liver cirrhosis with a Child-Pugh B or C classification as defined by; history of variceal bleeding, hepatic encephalopathy, or resistant ascites.
- History of bacterial cholangitis with hospitalization within 12 weeks prior to screening.
- Colectomy or any other colorectal resections.
- Breastfeeding or pregnancy.
- Diagnosis of HIV.
- Hepatocellular carcinoma or other hepatobiliary malignancy.
- 18. Participants concurrently, or within last 12 weeks, receiving study medication while included in other clinical trials.
- Current or history of colonic cancer or all-grade dysplasia described at the last colonoscopy.
- History of other malignancy of extra-hepatic origin within the last 3 years (recent localized treatment of squamous or non-invasive basal skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to screening).
- Any severe competing cardiovascular, renal, endocrine, or psychiatric disorder, which of the opinion of the investigator might have an influence on the patient’s compliance or the interpretation of the results.
- Drug abuse, regular use of recreational drugs within the last year, or any conditions associated with poor compliance.
- Vitamin B6 supplementation, any form or dose including standard multivitamins, previous 12 weeks to inclusion.
- Ongoing therapy with levodopa, isoniazid, hydralazine or penicillamine due to drug interactions
- Previous liver transplantation or anticipated need for liver transplantation within 6 months or listing for liver transplantation.
- Endoscopic treatment for bile duct stenosis 12 weeks prior to screening or planned within 12 weeks after inclusion.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.