rsodeoxycholic Acid (UDCA) in Preventing Hepatobiliary and Colorectal Malignancy in Surveillance Patients with Primary Sclerosing Cholangitis (PSC)

Phase 1

• Conditions: Primary sclerosing cholangitis with or without concomitant inflammatory bowel disease included in an unlimited surveillance program for hepatobiliary and colorectal malignancy; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-003310-24-SE
• Lead Sponsor: Sahlgrenska Academy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-01
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1.Inclusion in the SILK PSC surveillance program
2.MRCP or ERCP confirmed large-duct PSC
3.ALP at screening >1.5x ULN (at =2 opportunities during =six months)
4.PSC-associated symptoms at ALP =1.5x ULN
5.Currently not taking UDCA for =3 months.
Ongoing medication with UDCA is withdrawn for three months. These patients have an additional visit (V-1) three months before V1 (start of UDCA)
6.Age = 18 years
7.Written informed consent
8.Women with childbearing potential may participate in the trial since UDCA is considered save in pregnancy according to EASL and Swedish guidelines, at least in the second and third trimester, and is the first-line treatment in women with intrahepatic cholestasis of pregnancy (ICP). Pregnant women are advised to temporarily stop treatment with UDCA in the first trimester.
9. If a woman with PSC who is a UDCA non-responder becomes pregnant, UDCA may be administered for the treatment of ICP according to EASL and Swedish guidelines. UDCA then is withdrawn after delivery.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Chronic liver disease other than PSC (PBC, viral hepatitis, autoimmune liver disease, hemochromatosis, homozygous alpha1-antitrypsin deficiency and Wilson disease)
2. Evidence of a secondary cause of sclerosing cholangitis
3. Presence of complications or clinically significant hepatic decompensation of PSC:
•History of liver transplantation, current placement on a liver transplant list or current MELD score = 15
•Portal hypertension with complications, including: known gastric or large esophageal varices, history of variceal bleeds, poorly controlled or diuretic resistant ascites, transjugular intrahepatic portosystemic shunt [TIPS]), or hepatic encephalopathy
•Cirrhosis with complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma
•Hepatorenal syndrome (type I or II)
4. Presence of cholangiocarcinoma or other malignancy
5. Alcohol abuse (as assessed by the investigator)
6. Documented intolerance of UDCA, e.g., severe diarrhoea
7. Suggested non-compliance with the protocol.

Study & Design

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