Pyridoxine in primary sclerosing cholangitis

Phase 1

• Conditions: Primary sclerosing cholangitis; MedDRA version: 20.1Level: LLTClassification code: 10039717Term: Sclerosing cholangitis Class: 10019805; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2023-505155-47-00
• Lead Sponsor: Oslo University Hospital HF

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-08
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

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.

Exclusion Criteria

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. a1-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified