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A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness (TRANSFORM)

Primary Purpose

Primary Biliary Cholangitis, Liver Stiffness

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Setanaxib
Placebo
Sponsored by
Calliditas Therapeutics Suisse SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Biliary Cholangitis focused on measuring Setanaxib, Primary Biliary Cholangitis, Elevated Liver Stiffness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female participant aged ≥18 years, inclusive at the time of informed consent.
  • Willing and able to give written informed consent and to comply with the requirements of the study.
  • Definite or probable primary biliary cholangitis (PBC) diagnosis as demonstrated by the presence of ≥2 of the following 3 diagnostic factors:

    • Documented history of elevated alkaline phsopatase (ALP) levels ≥1.67×upper limit of normal (ULN) of the local reference range.
    • Documented history of positive antimitochondrial antibodies (AMA) titer or positive PBC-specific antibodies (anti-GP210 or anti-SP100 or antibodies against the major M2 components [PDC-E2, 2-oxo-glutaric acid dehydrogenase complex]).
    • Historical liver biopsy consistent with PBC.
  • Serum ALP ≥1.67×ULN at Screening.
  • Liver stiffness measured by transient elastography (FibroScan®) of ≥8.8 kilopascals (kPa) and an interquartile range over median ratio (IQR/med) of ≤30% at Screening, are taken with the results expressed in kilopascals).
  • Ursodeoxycholic acid (UDCA) prescriptional dose use for the past 6 months (at a stable dose for >3 months prior to Screening) OR intolerant to UDCA (last dose of UDCA >3 months prior to Screening). Intolerance to UDCA is defined as participants unable to tolerate the full-labelled dose of UDCA in PBC (13-15 mg/kg) due to frequently reported gastrointestinal symptoms such as diarrhea and abdominal pain.
  • For participants receiving obeticholic acid (OCA), fenofibrate, or bezafibrate treatment for at least 6 months and stable dose for >3 months prior to Screening.
  • For participants intolerant to OCA, OCA must have been discontinued >3 months prior to Screening.
  • For participants previously treated with bezafibrate or fenofibrate, and these agents were discontinued prior to screening, they must have been discontinued >3 months prior to Screening.
  • Female participants of childbearing potential must use a highly effective method of contraception to prevent pregnancy for ≥4 weeks before Randomization and must agree to continue strict contraception up to 90 days after the last dose of investigational medicinal product (IMP).

    • For the purposes of this trial, women of childbearing potential are defined as "Fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy."
    • Postmenopausal state is defined as no menses for 12 months without an alternative medical cause. In female participants who are not using hormonal contraception or hormonal replacement therapy but with suspected menopause and less than 12 months of amenorrhea, a high follicle stimulating hormone (FSH) level in the postmenopausal range will be required at Screening to confirm a postmenopausal state. Confirmation with more than one FSH measurement is required.
    • Highly effective contraception is defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly. These methods are:

      • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)
      • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable)
      • Intrauterine device
      • Intrauterine hormone-releasing system
      • Bilateral tubal occlusion
      • Vasectomized partner
      • Sexual abstinence (refraining from heterosexual intercourse during the entire period of risk associate with the study treatments). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together.
  • Female participants of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline/Randomization before dosing.
  • Male participants with female partners of childbearing potential must be willing to use a condom and require their partner to use a highly effective contraceptive method. This requirement begins at the time of informed consent and ends 90 days after receiving the last dose of IMP.
  • Male participants must be willing not to donate sperm, and female study participants must be willing not to donate eggs, from Baseline until 90 days after the last dose of IMP.

Exclusion Criteria:

  • A positive pregnancy test or breastfeeding for female participants.
  • Any historical or current hepatic decompensation event defined as variceal/portal hypertension bleed and/or hepatic encephalopathy, spontaneous bacterial peritonitis, ascites requiring treatment, or liver transplantation list inclusion.
  • History of liver transplantation, current placement on a liver transplant list or current model for end stage liver disease (MELD) score of ≥12 unless the participant is on anticoagulant therapy, or a Child-Pugh Score of ≥6.
  • Cirrhosis with complications, including history or presence of hepatocellular carcinoma.
  • Total bilirubin >2×ULN. In case of total bilirubin elevation >ULN the Screening serum albumin must be within the reference range.
  • Plasma alanine aminotransferase (ALT) >3×ULN and/or aspartate aminotransferase (AST) >3×ULN.
  • International normalized ratio (INR) >1.2 unless participant is on anticoagulant therapy. One repeat blood sampling (with analysis by the central laboratory) can be performed at the discretion of the Investigator at Screening Visit 2 for participants who meet this exclusion criterion at Screening Visit 1. If this exclusion criterion is not met at Screening Visit 2, the participant may be eligible for the study.
  • Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m^2, as calculated by the central laboratory using the chronic kidney disease-epidemiology collaboration (CKD- EPI) equation.
  • Thyroid-stimulating hormone >ULN at Screening. One repeat blood sampling (with analysis by the central laboratory) can be performed at the discretion of the Investigator at Screening Visit 2 for participants who meet this exclusion criterion at Screening Visit 1. If this exclusion criterion is not met at Screening Visit 2, the participant may be eligible for the study.
  • Competing etiology for liver disease (eg, hepatitis C [unless effectively cured of hepatitis C, with a sustained virologic response for at least 6 months prior to Screening], active hepatitis B [HBsAg positive], nonalcoholic steatohepatitis [NASH], alcoholic liver disease, autoimmune hepatitis, autoimmune hepatitis-PBC overlap syndrome, primary sclerosing cholangitis, Gilbert's Syndrome).
  • Medical conditions that could cause nonhepatic increases in ALP (eg, Paget's disease).
  • Known history of human immunodeficiency virus (HIV) infection.
  • Surgery (eg, stomach bypass) or medical condition that might significantly affect absorption of medicines (as judged by the Investigator).
  • Positive urine drug screen (if not due to prescriptional use of a concomitant medication, as confirmed by the Investigator) at Screening. Participants on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to Screening Visit 1 may be included in the study. Medicinal cannabis and cannabidiol products are not exclusionary and may be allowed if the prescription and diagnosis are reviewed and approved by the Investigator.
  • Participants receiving prohibited medications within 3 months of Screening Visit 1.
  • Treatment with any investigational agent within 12 weeks of Screening Visit 1 or 5 half-lives of the IMP (if known) (whichever is longer) or current enrollment in an interventional clinical trial.
  • Evidence of any of the following cardiac conduction abnormalities: A QTc Fridericia interval >450 milliseconds for males or >470 milliseconds for females, as calculated by the central reader. Participants with a second- or third-degree atrioventricular block are to be excluded.
  • For participants in the US, in participants treated with or for planned treatment with a pacemaker, implanted cardioverter-difibrillator, or other implanted electronic device, FibroScan® assessments will be prohibited.
  • History of a malignancy within 5 years of Screening with the following exceptions:

    • Adequately treated carcinoma in situ of the cervix
    • Adequately treated basal or squamous cell cancer or other localized nonmelanoma skin cancer.
  • The occurrence of any acute infection requiring systemic antibiotic therapy within the 2 weeks prior to Screening Visit 1.
  • A history of bone marrow disorder including aplastic anemia, or any current marked anemia defined as hemoglobin <10.0 g/dL.
  • Prior treatment with setanaxib or participation in a previous setanaxib clinical trial.
  • Unstable cardiovascular disease.
  • Presence of any laboratory abnormality or condition that, in the opinion of the Investigator, could interfere with or compromise a participant's treatment, assessment, or compliance with the protocol and/or study procedures.
  • Any other condition which, in the opinion of the Investigator, constitutes a risk or contraindication for the participation of the participant in the study, or that could interfere with the study objectives, conduct, or evaluation.
  • Hypersensitivity or intolerance to setanaxib or to any of its excipients or placebo compounds.

Sites / Locations

  • UA Thomas D. Boyer Liver InstituteRecruiting
  • Cedars-Sinai Medical CenterRecruiting
  • California Liver Research InstituteRecruiting
  • University of California Davis Medical CenterRecruiting
  • Gastroenterology Associates - Crystal RiverRecruiting
  • University of Miami Leonard M. Miller School of MedicineRecruiting
  • AdventHealth Transplant InstituteRecruiting
  • Advanced Research Institute, Inc.Recruiting
  • Tampa General HospitalRecruiting
  • Northwestern UniversityRecruiting
  • Springfield ClinicRecruiting
  • Kansas Medical Clinic - GastroenterologyRecruiting
  • Tulane Medical CenterRecruiting
  • A. Alfred Taubman Health Care CenterRecruiting
  • Henry Ford HospitalRecruiting
  • Summit - Southern Therapy and Advanced Research
  • Northwell Health
  • New York University Hepatology AssociatesRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting
  • Wake Forest University Baptist Medical CenterRecruiting
  • University of CincinnatiRecruiting
  • Einstein Medical CenterRecruiting
  • Rapid City Medical CenterRecruiting
  • Vanderbilt Digestive Disease CenterRecruiting
  • Liver Specialists of TexasRecruiting
  • Pioneer Research SolutionsRecruiting
  • University of Utah HospitalRecruiting
  • Froedtert and Medical College of WisconsinRecruiting
  • Royal Prince Alfred HospitalRecruiting
  • John Hunter HospitalRecruiting
  • Mater Misericordiae - Hospital BrisbaneRecruiting
  • Flinders Medical CentreRecruiting
  • Eastern Health - AustraliaRecruiting
  • Monash Medical CentreRecruiting
  • Fiona Stanley HospitalRecruiting
  • Nepean HospitalRecruiting
  • Liverpool HospitalRecruiting
  • The Alfred HospitalRecruiting
  • Ordensklinikum Linz GmbH Barmherzige SchwesternRecruiting
  • Klinikum Wels-GrieskirchenRecruiting
  • Universitaetsklinikum Graz - Universitätsklinik für Innere MedizinRecruiting
  • Medizinische Universität InnsbruckRecruiting
  • Hôpital ErasmeRecruiting
  • Centre Hospitalier Universitaire Brugmann - Site Victor HortaRecruiting
  • Universitair Ziekenhuis Leuven - Campus GasthuisbergRecruiting
  • Universitair Ziekenhuis GentRecruiting
  • University of CalgaryRecruiting
  • Queen Elizabeth II Health Sciences Centre - Victoria GeneralRecruiting
  • St. Joseph's Healthcare Hamilton - Charlton CampusRecruiting
  • Centricity Research (LMC Manna Research) - LondonRecruiting
  • Office Of Stephane M. GauthierRecruiting
  • University Health NetworkRecruiting
  • Toronto Liver CenterRecruiting
  • Centre Hospitalier de l'Université de Montréal (CHUM)Recruiting
  • William Osler Health System - Brampton Civic HospitalRecruiting
  • Ústřední Vojenská Nemocnice PrahaRecruiting
  • Hepato-Gastroenterologie HKRecruiting
  • Hôpital Claude HuriezRecruiting
  • Hôpitaux Universitaires Henri MondorRecruiting
  • Centre Hospitalier Universitaire Grenoble AlpesRecruiting
  • Hopital DupuytrenRecruiting
  • Hôpitaux de BraboisRecruiting
  • Hôpital RangueilRecruiting
  • Clinique Pasteur - ToulouseRecruiting
  • Centre Hosptitalier Universitaire d'AngersRecruiting
  • Centre Hospitalier Universitaire Amiens-Picardie - Site SudRecruiting
  • Hôpital de la Croix RousseRecruiting
  • Hôpital Claude HuriezRecruiting
  • Hôpital Saint Joseph MarseilleRecruiting
  • Hôpital l'ArchetRecruiting
  • Hôpital Saint-AntoineRecruiting
  • Klinikum rechts der Isar der Technischen Universität MünchenRecruiting
  • Universitätsklinikum FrankfurtRecruiting
  • St. Josefs-Hospital WiesbadenRecruiting
  • Medizinische Hochschule HannoverRecruiting
  • EugastroRecruiting
  • Universitätsklinikum des SaarlandesRecruiting
  • University General Hospital of Heraklion (PAGNI)Recruiting
  • University General Hospital of LarissaRecruiting
  • Semmelweis Egyetem - I. Sz. Sebészeti és Intervenciós Gasztroenterológiai KlinikaRecruiting
  • Carmel Medical CenterRecruiting
  • Western Galilee Hospital-NahariyaRecruiting
  • Soroka Medical CenterRecruiting
  • Rabin Medical Center - Beilinson HospitalRecruiting
  • Rambam Health Care CampusRecruiting
  • Hadassah University Hospital Ein KeremRecruiting
  • Tel Aviv Sourasky Medical CenterRecruiting
  • Ospedale San GiuseppeRecruiting
  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico HumanitasRecruiting
  • Azienda Socio Sanitaria Territoriale Monza - Ospedale San GerardoRecruiting
  • Azienda Ospedaliero Universitaria Ospedali Riuniti di AnconaRecruiting
  • Azienda Ospedaliera Universitaria Policlinico Gaetano MartinoRecruiting
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoRecruiting
  • Università degli Studi di Napoli Federico IIRecruiting
  • Azienda Ospedaliero-Universitaria Maggiore della Carità di NovaraRecruiting
  • Auckland City HospitalRecruiting
  • Wellington Regional HospitalRecruiting
  • Dunedin HospitalRecruiting
  • Waikato HospitalRecruiting
  • Szpital Specjalistyczny Nr 1 w BytomiuRecruiting
  • ID ClinicRecruiting
  • Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.Recruiting
  • Hospital Germans Trias i PujolRecruiting
  • Hospital de SabadellRecruiting
  • Hospital Universitario de CanariasRecruiting
  • Hospital General Universitari d'AlicanteRecruiting
  • Complejo Hospitalario TorrecárdenasRecruiting
  • Hospital del Mar - Parc de Salut MarRecruiting
  • Hospital Clínic de BarcelonaRecruiting
  • Hospital Universitario Reina SofíaRecruiting
  • Hospital Universitario de La PrincesaRecruiting
  • Hospital General Universitario Gregorio MarañónRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital Universitario Virgen de la VictoriaRecruiting
  • Hospital Clínico Universitario de SantiagoRecruiting
  • Hospital Universitario Virgen del RocíoRecruiting
  • Consorci Hospital General Universitari de ValènciaRecruiting
  • Hospital Universitario Miguel ServetRecruiting
  • Akademiska Sjukhuset - UppsalaRecruiting
  • Fondazione Epatocentro TicinoRecruiting
  • Kantonsspital Sankt GallenRecruiting
  • Gloucestershire Hospitals NHS Foundation TrustRecruiting
  • King's College Hospital NHS Foundation TrustRecruiting
  • The Newcastle Upon Tyne Hospitals NHS Foundation TrustRecruiting
  • Nottingham University Hospitals NHS TrustRecruiting
  • Sheffield Teaching Hospitals NHS Foundation TrustRecruiting
  • University Hospital Southampton NHS Foundation TrustRecruiting
  • NHS Greater Glasgow and ClydeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Setanaxib 1200 mg/day

Setanaxib 1600 mg/day

Placebo

Arm Description

Participants will be administered setanaxib at a dose of 1200 mg/day for the 52-week double-blind treatment period and the 52-week extension period. The interim analysis outcome will determine if the setanaxib dose level for participants receiving 1200 mg/day will be escalated to 1600 mg/day for the continued extension period.

Participants will be administered setanaxib at a dose of 1600 mg/day for the 52-week double-blind treatment period and the 52-week extension period. The interim analysis outcome will determine if the setanaxib dose level for participants receiving 1600 mg/day will be reduced to 1200 mg/day for the continued extension period.

Participants will be administered a placebo for the 52-week double-blind treatment period. During the 52-week extension period, participants will switch from placebo to setanaxib at a dose of either 1200 or 1600 mg/day depending on interim analysis outcome.

Outcomes

Primary Outcome Measures

Proportion of Participants Achieving a Biochemical Response to Setanaxib
Biochemical response defined as alkaline phosphatase (ALP) reduction to <1.67x upper limit of normal (ULN), ALP reduction ≥15% from baseline and total bilirubin ≤1xULN.

Secondary Outcome Measures

Change from Baseline in Fatigue
Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) short form-Fatigue 7b Daily.
Change from Screening in Liver Stiffness
Assessed by transient elastography (FibroScan®).
Change from Baseline in Primary Biliary Cirrhosis (PBC)-40 Fatigue Domain
Change from Baseline in Patient's Global Impression of Severity (PGIS) Fatigue
PGIS is measured on a 5-point scale, with 1 indicating symptoms are not present and 5 indicating very severe symptoms.
Change from Baseline in Patient's Global Impression of Change (PGIC) Fatigue
PGIC is measured on a 7-point scale, with 1 indicating symptoms are much better and 7 indicating symptoms are much worse.
Change from Baseline in Worst Itch Numerical Scale Rating Scale (WI-NRS)
WI-NRS is measured on a 11-point scale, with 0 indicating no itch and 10 indicating worst possible itch.
Change from Baseline in Primary Biliary Cirrhosis (PBC)-40 Itch Domain
Change from Baseline in Patient's Global Impression of Severity (PGIS) Pruritus
PGIS is measured on a 5-point scale, with 1 indicating symptoms are not present and 5 indicating very severe symptoms.
Change from Baseline in Patient's Global Impression of Change (PGIC) Pruritus
PGIC is measured on a 7-point scale, with 1 indicating symptoms are much better and 7 indicating symptoms are much worse.
Proportion of Participants with Treatment-Emergent Adverse Events (TEAEs)
A TEAE is defined as any untoward medical occurrence in participants that happens after study drug administration. Any clinically significant abnormalities in vital signs, clinical laboratory tests (including biochemistry, hematology, urinalysis, and thyroid function), or 12- lead electrocardiogram (ECG) results will be recorded as Adverse Events (AEs). AEs will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE); Version 4.03.
Proportion of Participants Who Experience Adverse Events of Special Interest (AESIs)
AESIs include drug-induced liver injury (DILI), anemia and hypothyroidism.

Full Information

First Posted
August 10, 2021
Last Updated
October 17, 2023
Sponsor
Calliditas Therapeutics Suisse SA
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1. Study Identification

Unique Protocol Identification Number
NCT05014672
Brief Title
A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness
Acronym
TRANSFORM
Official Title
TRANSFORM: A 52-week, Randomized, Placebo-controlled, Double-blind, Adaptive Phase 2b/3 Trial of Setanaxib With a 52-week Extension Phase in Patients With Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
September 16, 2024 (Anticipated)
Study Completion Date
September 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Calliditas Therapeutics Suisse SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the effect of setanaxib on biochemical response at Week 52 in participants with primary biliary cholangitis (PBC) and with elevated liver stiffness and intolerance or inadequate response to ursodeoxycholic acid (UDCA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cholangitis, Liver Stiffness
Keywords
Setanaxib, Primary Biliary Cholangitis, Elevated Liver Stiffness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Placebo-controlled 1:1:1 in double blind treatment period with 1:1 reassignment to setanaxib in extension period
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
318 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Setanaxib 1200 mg/day
Arm Type
Experimental
Arm Description
Participants will be administered setanaxib at a dose of 1200 mg/day for the 52-week double-blind treatment period and the 52-week extension period. The interim analysis outcome will determine if the setanaxib dose level for participants receiving 1200 mg/day will be escalated to 1600 mg/day for the continued extension period.
Arm Title
Setanaxib 1600 mg/day
Arm Type
Experimental
Arm Description
Participants will be administered setanaxib at a dose of 1600 mg/day for the 52-week double-blind treatment period and the 52-week extension period. The interim analysis outcome will determine if the setanaxib dose level for participants receiving 1600 mg/day will be reduced to 1200 mg/day for the continued extension period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be administered a placebo for the 52-week double-blind treatment period. During the 52-week extension period, participants will switch from placebo to setanaxib at a dose of either 1200 or 1600 mg/day depending on interim analysis outcome.
Intervention Type
Drug
Intervention Name(s)
Setanaxib
Intervention Description
Oral tablets, 400mg per tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablets
Primary Outcome Measure Information:
Title
Proportion of Participants Achieving a Biochemical Response to Setanaxib
Description
Biochemical response defined as alkaline phosphatase (ALP) reduction to <1.67x upper limit of normal (ULN), ALP reduction ≥15% from baseline and total bilirubin ≤1xULN.
Time Frame
Baseline (Day 1) up to Week 52
Secondary Outcome Measure Information:
Title
Change from Baseline in Fatigue
Description
Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) short form-Fatigue 7b Daily.
Time Frame
Baseline (Day 1) and Week 52
Title
Change from Screening in Liver Stiffness
Description
Assessed by transient elastography (FibroScan®).
Time Frame
Screening (Day -28) and Week 52
Title
Change from Baseline in Primary Biliary Cirrhosis (PBC)-40 Fatigue Domain
Time Frame
Baseline (Day 1) and Week 52
Title
Change from Baseline in Patient's Global Impression of Severity (PGIS) Fatigue
Description
PGIS is measured on a 5-point scale, with 1 indicating symptoms are not present and 5 indicating very severe symptoms.
Time Frame
Baseline (Day 1) and Week 52
Title
Change from Baseline in Patient's Global Impression of Change (PGIC) Fatigue
Description
PGIC is measured on a 7-point scale, with 1 indicating symptoms are much better and 7 indicating symptoms are much worse.
Time Frame
Baseline (Day 1) and Week 52
Title
Change from Baseline in Worst Itch Numerical Scale Rating Scale (WI-NRS)
Description
WI-NRS is measured on a 11-point scale, with 0 indicating no itch and 10 indicating worst possible itch.
Time Frame
Baseline (Day 1) and Week 52
Title
Change from Baseline in Primary Biliary Cirrhosis (PBC)-40 Itch Domain
Time Frame
Baseline (Day 1) and Week 52
Title
Change from Baseline in Patient's Global Impression of Severity (PGIS) Pruritus
Description
PGIS is measured on a 5-point scale, with 1 indicating symptoms are not present and 5 indicating very severe symptoms.
Time Frame
Baseline (Day 1) and Week 52
Title
Change from Baseline in Patient's Global Impression of Change (PGIC) Pruritus
Description
PGIC is measured on a 7-point scale, with 1 indicating symptoms are much better and 7 indicating symptoms are much worse.
Time Frame
Baseline (Day 1) and Week 52
Title
Proportion of Participants with Treatment-Emergent Adverse Events (TEAEs)
Description
A TEAE is defined as any untoward medical occurrence in participants that happens after study drug administration. Any clinically significant abnormalities in vital signs, clinical laboratory tests (including biochemistry, hematology, urinalysis, and thyroid function), or 12- lead electrocardiogram (ECG) results will be recorded as Adverse Events (AEs). AEs will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE); Version 4.03.
Time Frame
Up to Week 52
Title
Proportion of Participants Who Experience Adverse Events of Special Interest (AESIs)
Description
AESIs include drug-induced liver injury (DILI), anemia and hypothyroidism.
Time Frame
Up to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female participant aged ≥18 years, inclusive at the time of informed consent. Willing and able to give written informed consent and to comply with the requirements of the study. Definite or probable primary biliary cholangitis (PBC) diagnosis as demonstrated by the presence of ≥2 of the following 3 diagnostic factors: Documented history of elevated alkaline phosphatase (ALP) levels ≥1.67×upper limit of normal (ULN) of the local reference range. Documented history of positive antimitochondrial antibodies (AMA) titer or positive PBC-specific antibodies (anti-GP210 or anti-SP100 or antibodies against the major M2 components [PDC-E2, 2-oxo-glutaric acid dehydrogenase complex]). Historical liver biopsy consistent with PBC. Serum ALP ≥1.67×ULN at Screening. Liver stiffness measured by transient elastography (FibroScan®) of ≥8.8 kilopascals (kPa) and an interquartile range over median ratio (IQR/med) of ≤30% at Screening, are taken with the results expressed in kilopascals). Ursodeoxycholic acid (UDCA) prescriptional dose use for the past 6 months (at a stable dose for >3 months prior to Screening) OR intolerant to UDCA (last dose of UDCA >3 months prior to Screening). Intolerance to UDCA is defined as participants unable to tolerate the full-labelled dose of UDCA in PBC (13-15 mg/kg) due to frequently reported gastrointestinal symptoms such as diarrhea and abdominal pain. For participants receiving obeticholic acid (OCA), fenofibrate, or bezafibrate treatment for at least 6 months and stable dose for >3 months prior to Screening. For participants intolerant to OCA, OCA must have been discontinued >3 months prior to Screening. For participants previously treated with bezafibrate or fenofibrate, and these agents were discontinued prior to screening, they must have been discontinued >3 months prior to Screening. Female participants of childbearing potential must use a highly effective method of contraception to prevent pregnancy for ≥4 weeks before Randomization and must agree to continue strict contraception up to 90 days after the last dose of investigational medicinal product (IMP). For the purposes of this trial, women of childbearing potential are defined as "Fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy." Postmenopausal state is defined as no menses for 12 months without an alternative medical cause. In female participants who are not using hormonal contraception or hormonal replacement therapy but with suspected menopause and less than 12 months of amenorrhea, a high follicle stimulating hormone (FSH) level in the postmenopausal range will be required at Screening to confirm a postmenopausal state. Confirmation with more than one FSH measurement is required. Highly effective contraception is defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly. These methods are: Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal) Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable) Intrauterine device Intrauterine hormone-releasing system Bilateral tubal occlusion Vasectomized partner Sexual abstinence (refraining from heterosexual intercourse during the entire period of risk associate with the study treatments). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together. Female participants of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline/Randomization before dosing. Male participants with female partners of childbearing potential must be willing to use a condom and require their partner to use a highly effective contraceptive method. This requirement begins at the time of informed consent and ends 90 days after receiving the last dose of IMP. Male participants must be willing not to donate sperm, and female study participants must be willing not to donate eggs, from Baseline until 90 days after the last dose of IMP. Exclusion Criteria: A positive pregnancy test or breastfeeding for female participants. Any historical or current hepatic decompensation event defined as variceal/portal hypertension bleed and/or hepatic encephalopathy, spontaneous bacterial peritonitis, ascites requiring treatment, or liver transplantation list inclusion. History of liver transplantation, current placement on a liver transplant list or current model for end stage liver disease (MELD) score of ≥12 unless the participant is on anticoagulant therapy, or a Child-Pugh Score of ≥6. Cirrhosis with complications, including history or presence of hepatocellular carcinoma. Total bilirubin >2×ULN. In case of total bilirubin elevation >ULN the Screening serum albumin must be within the reference range. Plasma alanine aminotransferase (ALT) >3×ULN and/or aspartate aminotransferase (AST) >3×ULN. International normalized ratio (INR) >1.2 unless participant is on anticoagulant therapy. One repeat blood sampling (with analysis by the central laboratory) can be performed at the discretion of the Investigator at Screening Visit 2 for participants who meet this exclusion criterion at Screening Visit 1. If this exclusion criterion is not met at Screening Visit 2, the participant may be eligible for the study. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m^2, as calculated by the central laboratory using the chronic kidney disease-epidemiology collaboration (CKD- EPI) equation. Thyroid-stimulating hormone >ULN at Screening. One repeat blood sampling (with analysis by the central laboratory) can be performed at the discretion of the Investigator at Screening Visit 2 for participants who meet this exclusion criterion at Screening Visit 1. If this exclusion criterion is not met at Screening Visit 2, the participant may be eligible for the study. Competing etiology for liver disease (eg, hepatitis C [unless effectively cured of hepatitis C, with a sustained virologic response for at least 6 months prior to Screening], active hepatitis B [HBsAg positive], nonalcoholic steatohepatitis [NASH], alcoholic liver disease, autoimmune hepatitis, autoimmune hepatitis-PBC overlap syndrome, primary sclerosing cholangitis, Gilbert's Syndrome). Medical conditions that could cause nonhepatic increases in ALP (eg, Paget's disease). Known history of human immunodeficiency virus (HIV) infection. Surgery (eg, stomach bypass) or medical condition that might significantly affect absorption of medicines (as judged by the Investigator). Positive urine drug screen (if not due to prescriptional use of a concomitant medication, as confirmed by the Investigator) at Screening. Participants on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to Screening Visit 1 may be included in the study. Medicinal cannabis and cannabidiol products are not exclusionary and may be allowed if the prescription and diagnosis are reviewed and approved by the Investigator. Participants receiving prohibited medications within 3 months of Screening Visit 1. Treatment with any investigational agent within 12 weeks of Screening Visit 1 or 5 half-lives of the IMP (if known) (whichever is longer) or current enrollment in an interventional clinical trial. Evidence of any of the following cardiac conduction abnormalities: A QTc Fridericia interval >450 milliseconds for males or >470 milliseconds for females, as calculated by the central reader. Participants with a second- or third-degree atrioventricular block are to be excluded. For participants in the US, in participants treated with or for planned treatment with a pacemaker, implanted cardioverter-defibrillator, or other implanted electronic device, FibroScan® assessments will be prohibited. History of a malignancy within 5 years of Screening with the following exceptions: Adequately treated carcinoma in situ of the cervix Adequately treated basal or squamous cell cancer or other localized nonmelanoma skin cancer. The occurrence of any acute infection requiring systemic antibiotic therapy within the 2 weeks prior to Screening Visit 1. A history of bone marrow disorder including aplastic anemia, or any current marked anemia defined as hemoglobin <10.0 g/dL. Prior treatment with setanaxib or participation in a previous setanaxib clinical trial. Unstable cardiovascular disease. Presence of any laboratory abnormality or condition that, in the opinion of the Investigator, could interfere with or compromise a participant's treatment, assessment, or compliance with the protocol and/or study procedures. Any other condition which, in the opinion of the Investigator, constitutes a risk or contraindication for the participation of the participant in the study, or that could interfere with the study objectives, conduct, or evaluation. Hypersensitivity or intolerance to setanaxib or to any of its excipients or placebo compounds.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Carlsson
Phone
+46 8 411 3005
Email
Stefan.carlsson@calliditas.com
Facility Information:
Facility Name
UA Thomas D. Boyer Liver Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Name
California Liver Research Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Name
Gastroenterology Associates - Crystal River
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Miami Leonard M. Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
AdventHealth Transplant Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Research Institute, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Individual Site Status
Recruiting
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9248
Country
United States
Individual Site Status
Recruiting
Facility Name
Kansas Medical Clinic - Gastroenterology
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Individual Site Status
Recruiting
Facility Name
Tulane Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Name
A. Alfred Taubman Health Care Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Summit - Southern Therapy and Advanced Research
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Northwell Health
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
New York University Hepatology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0595
Country
United States
Individual Site Status
Recruiting
Facility Name
Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Individual Site Status
Recruiting
Facility Name
Rapid City Medical Center
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt Digestive Disease Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
Liver Specialists of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Pioneer Research Solutions
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Name
Froedtert and Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Name
John Hunter Hospital
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Individual Site Status
Recruiting
Facility Name
Mater Misericordiae - Hospital Brisbane
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Recruiting
Facility Name
Eastern Health - Australia
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Recruiting
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Name
Nepean Hospital
City
Kingswood
ZIP/Postal Code
2747
Country
Australia
Individual Site Status
Recruiting
Facility Name
Liverpool Hospital
City
Liverpool
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Alfred Hospital
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Ordensklinikum Linz GmbH Barmherzige Schwestern
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4010
Country
Austria
Individual Site Status
Recruiting
Facility Name
Klinikum Wels-Grieskirchen
City
Wels
State/Province
Oberösterreich
ZIP/Postal Code
4600
Country
Austria
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Graz - Universitätsklinik für Innere Medizin
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Hôpital Erasme
City
Bruxelles
State/Province
Brussels
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Brugmann - Site Victor Horta
City
Laeken
State/Province
Brussels
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
City
Leuven
State/Province
Flemish Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Queen Elizabeth II Health Sciences Centre - Victoria General
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Individual Site Status
Recruiting
Facility Name
St. Joseph's Healthcare Hamilton - Charlton Campus
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centricity Research (LMC Manna Research) - London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 2C2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Office Of Stephane M. Gauthier
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 2H3
Country
Canada
Individual Site Status
Recruiting
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Toronto Liver Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Individual Site Status
Recruiting
Facility Name
William Osler Health System - Brampton Civic Hospital
City
Brampton
ZIP/Postal Code
L6R 3J7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Ústřední Vojenská Nemocnice Praha
City
Praha
State/Province
Prague
ZIP/Postal Code
169 02
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Hepato-Gastroenterologie HK
City
Hradec Králové
ZIP/Postal Code
500 12
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Hôpital Claude Huriez
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpitaux Universitaires Henri Mondor
City
Créteil
State/Province
Ile-de-France
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Grenoble Alpes
City
Grenoble
State/Province
Isère
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Dupuytren
City
Limoges
State/Province
Limousin
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpitaux de Brabois
City
Vandœuvre-lès-Nancy
State/Province
Lorraine
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Rangueil
City
Toulouse
State/Province
Occitanie
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Clinique Pasteur - Toulouse
City
Toulouse
State/Province
Occitanie
ZIP/Postal Code
31076
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hosptitalier Universitaire d'Angers
City
Angers
State/Province
Pays De La Loire
ZIP/Postal Code
49 933
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Amiens-Picardie - Site Sud
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital de la Croix Rousse
City
Lyon
State/Province
Rhone-alpes
ZIP/Postal Code
69317
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Saint Joseph Marseille
City
Marseille
ZIP/Postal Code
13008
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital l'Archet
City
Nice
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Name
Klinikum rechts der Isar der Technischen Universität München
City
Munich
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
St. Josefs-Hospital Wiesbaden
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65189
Country
Germany
Individual Site Status
Recruiting
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Eugastro
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Individual Site Status
Recruiting
Facility Name
University General Hospital of Heraklion (PAGNI)
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Individual Site Status
Recruiting
Facility Name
University General Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem - I. Sz. Sebészeti és Intervenciós Gasztroenterológiai Klinika
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Carmel Medical Center
City
Haifa
State/Province
Haifa District
ZIP/Postal Code
3436212
Country
Israel
Individual Site Status
Recruiting
Facility Name
Western Galilee Hospital-Nahariya
City
Nahariya
State/Province
Northern District
ZIP/Postal Code
22100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Soroka Medical Center
City
Be'er Sheva
State/Province
Southern District
ZIP/Postal Code
84101
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center - Beilinson Hospital
City
Petah Tikva
State/Province
Tel Aviv
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah University Hospital Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Name
Ospedale San Giuseppe
City
Milan
State/Province
Milano
ZIP/Postal Code
20123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo
City
Monza
State/Province
Monza And Brianza
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
City
Ancona
ZIP/Postal Code
60020
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Policlinico Gaetano Martino
City
Messina
ZIP/Postal Code
98124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Università degli Studi di Napoli Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
City
Novara
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Auckland City Hospital
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Wellington Regional Hospital
City
Crofton Downs
State/Province
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Dunedin Hospital
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Szpital Specjalistyczny Nr 1 w Bytomiu
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Individual Site Status
Recruiting
Facility Name
ID Clinic
City
Myslowice
ZIP/Postal Code
41-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
City
Wrocław
ZIP/Postal Code
51-162
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de Sabadell
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Canarias
City
La Laguna
State/Province
Santa Cruz De Tenerife
ZIP/Postal Code
38320
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitari d'Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Torrecárdenas
City
Almería
ZIP/Postal Code
04009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital del Mar - Parc de Salut Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínico Universitario de Santiago
City
Santiago
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Consorci Hospital General Universitari de València
City
València
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Akademiska Sjukhuset - Uppsala
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Fondazione Epatocentro Ticino
City
Lugano
State/Province
Ticino
ZIP/Postal Code
6900
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Kantonsspital Sankt Gallen
City
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Gloucestershire Hospitals NHS Foundation Trust
City
Gloucester
State/Province
England
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
King's College Hospital NHS Foundation Trust
City
London
State/Province
England
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
City
Newcastle upon Tyne
State/Province
England
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
State/Province
England
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness

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