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    Summary
    EudraCT Number:2015-003310-24
    Sponsor's Protocol Code Number:UDCAPSCSURV
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-09-01
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2015-003310-24
    A.3Full title of the trial
    A Phase 3, Open-label, Randomized, Prospective Clinical Trial Evaluating the Efficacy of Stratified Treatment with Ursodeoxycholic Acid (UDCA) in Preventing Hepatobiliary and Colorectal Malignancy in Surveillance Patients with Primary Sclerosing Cholangitis (PSC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ursodeoxycholic Acid (UDCA) in Preventing Hepatobiliary and Colorectal Malignancy in Surveillance Patients with Primary Sclerosing Cholangitis (PSC)
    A.3.2Name or abbreviated title of the trial where available
    UDCAPSCSURV
    A.4.1Sponsor's protocol code numberUDCAPSCSURV
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSahlgrenska Academy
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportALF Västra Götaland Regional Council
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSahlgrenska Acaedmy
    B.5.2Functional name of contact pointHanns-Ulrich Marschall
    B.5.3 Address:
    B.5.3.1Street AddressBlå Stråket 5
    B.5.3.2Town/ cityGöteborg
    B.5.3.3Post code41345
    B.5.3.4CountrySweden
    B.5.4Telephone number46708774073
    B.5.5Fax number4631827458
    B.5.6E-mailhanns-ulrich.marschall@gu.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ursofalk
    D.2.1.1.2Name of the Marketing Authorisation holderDr Falk Pharma GmbH Leinenweberstrasse 5 79108 Freiburg Germany
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameUrsofalk
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary sclerosing cholangitis with or without concomitant inflammatory bowel disease included in an unlimited surveillance program for hepatobiliary and colorectal malignancy
    E.1.1.1Medical condition in easily understood language
    Primary sclerosing cholangitis with or without concomitant inflammatory bowel disease
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    (i) To assess in incidence of biliary malignancy as assessed by surveillance MR/MRCP in patients with PSC with and without response to UDCA
    (ii) To assess in incidence of colorectal malignancy as assessed by surveillance colonoscopy in patients with PSC with and without response to UDCA
    E.2.2Secondary objectives of the trial
    (i) To assess safety and tolerability of 17-23 mg/kg/d of UDCA
    (ii) To assess the effect of UDCA on progression of liver failure (MELD score)
    (iii) To assess the effect of UDCA on development of complications of liver cirrhosis
    (iv) To assess the effect of UDCA on liver transplant-free survival
    (v) To assess the effect of UDCA on liver biochemistry (ALP, bilirubin, ALT, AST)
    (vi) To assess the effect of UDCA on inflammation markers CRP, TNFα, IL-6
    (vii) To assess the effect of UDCA on tumor markers CA19-9 and CEA
    (viii)To assess the effect of UDCA on inflammatory bowel disease activity (MAYO scores)
    (ix) To assess the effect of UDCA on pruritus as assessed by visible analogue scale (VAS)
    (x) To assess the effect of UDCA on serum and fecal bile acids
    (xi) To assess the effect of UDCA on gut microbiota diversity
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary end point(s)
    - any hepatobiliary malignancy including low-grade dysplasia detected by surveillance MRCP
    - any colorectal malignancy including low-grade dysplasia detected by surveillance colonoscopy
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every year after annual MRCP and colonoscopy
    E.5.2Secondary end point(s)
    - any incidental hepatobiliary malignancy including high-grade dysplasia
    - any incidental colorectal malignancy including high-grade dysplasia
    - progress to Child C liver cirrhosis
    - pruritus refractory to anion exchange raisins
    - liver transplantation
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every year after annual MRCP and colonoscopy
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state500
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Continous surveillance in any subject included
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-10-11
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