Back to resultsA Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC) (VISTAS)
Primary Purpose
Primary Sclerosing Cholangitis
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Volixibat
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Primary Sclerosing Cholangitis focused on measuring Pruritus, PSC, Itch, Itching, Cholestasis
Eligibility Criteria
Inclusion Criteria:
- Provide freely signed informed consent and assent (as applicable) and be willing to comply with all study visits and requirements through end of study, including the follow-up period.
- Subjects aged ≥16 years for eligible regions
- Confirmed diagnosis of large duct or small duct PSC based on American Association for the Study of Liver Disease (AASLD) guidelines.
- Qualified pruritus associated with PSC as assessed by Adult ItchRO.
- Ursodeoxycholic acid (UDCA) and anti-pruritic medication use will be allowed if meeting additional criteria.
- Concomitant Inflammatory Bowel Disease (IBD) is allowed if meeting additional criteria.
Exclusion Criteria:
- Pruritus associated with an etiology other than PSC
- Evidence or clinical suspicion of decompensated cirrhosis, or a history of decompensation events
- History of ileostomy or small bowel surgery/resection or other surgeries that may have disrupted the enterohepatic circulation
- Evidence, history, or suspicion of other liver diseases
- Bile duct stent or percutaneous bile duct drain placement, or balloon dilatation procedure of a stricture within 12 weeks of Screening
- Exceeding pre-defined biochemical values for alanine aminotransferase/aspartate aminotransferase (ALT/AST), estimated glomerular filtration rate (eGFR),serum creatinine (sCr), platelet count, international normalized ratio (INR) and total bilirubin
- History of liver transplantation
Sites / Locations
- Southern California Research CenterRecruiting
- Cedars Sinai Medical CenterRecruiting
- University of California, DavisRecruiting
- California Pacific Medical Center Research InstituteRecruiting
- University of Colorado - Anschutz Medical CampusRecruiting
- MedStar Georgetown University HospitalRecruiting
- Florida Research InstituteRecruiting
- University of Miami - Schiff Center for Liver DiseasesRecruiting
- Tampa General HospitalRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- Henry Ford HospitalRecruiting
- Mayo ClinicRecruiting
- Southern Therapy and Advanced Research LLC
- Northwell Health
- New York University Langone HealthRecruiting
- Weill Cornell Medical CollegeRecruiting
- Columbia University Irving Medical Center - Research PharmacyRecruiting
- University of Rochester Medical Center - Strong Memorial Hospital
- Duke Health - Duke University Medical CenterRecruiting
- Cleveland ClinicRecruiting
- Einstein Healthcare Network - Einstein Medical CenterRecruiting
- University of Pittsburgh Medical CenterRecruiting
- Galen Medical GroupRecruiting
- Vanderbilt University Medical CenterRecruiting
- The Liver Institute At Methodist Dallas Medical CenterRecruiting
- University of Texas Southwestern Medical CenterRecruiting
- Houston Methodist HospitalRecruiting
- Liver Associates of TexasRecruiting
- University of Utah Health CareRecruiting
- Bon Secours Liver Institution of Hampton Roads Mary Immaculate Hospital OfficeRecruiting
- Richmond Community Hospital LLCRecruiting
- University of Washington - Harborview Medical Center
- Liver Institute NorthwestRecruiting
- The Ottawa Hospital - General Campus
- University Health Network - Toronto General HospitalRecruiting
- Hannover Medical SchoolRecruiting
- Universitaetsklinikum BonnRecruiting
- Charité Universtitätsmedizin - Campus Virchow-KlinikumRecruiting
- Universitaetsklinikum Erlangen
- Universitätsklinikum Schleswig-Holstein - Campus KielRecruiting
- Universitatsklinikum LeipzigRecruiting
- University Hospital Tubingen Medical ClinicRecruiting
- St. Josefs-Hospital WiesbadenRecruiting
- Rambam Medical CenterRecruiting
- Carmel Medical CenterRecruiting
- Shaare Zedek Medical CenterRecruiting
- Hadassah Medical Center - Ein KaremRecruiting
- Galilee Medical CenterRecruiting
- Rabin Medical CenterRecruiting
- Sheba Medical CenterRecruiting
- Tel Aviv Sourasky Medical CenterRecruiting
- Royal Free HospitalRecruiting
- John Radcliffe HospitalRecruiting
- Royal Victoria HospitalRecruiting
- University Hospitals Birmingham NHS Foundation Trust - Wellcome Trust Birmingham Clinical Research FacilityRecruiting
- Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's HospitalRecruiting
- Lothian NHS BoardRecruiting
- St James' University Hospital Leeds Teaching Hospitals NHS Trust
- King's College Hospital NHS Foundation TrustRecruiting
- University Hospital Southampton NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Volixibat 20mg
Volixibat 80mg
Placebo
Arm Description
Participants randomized to this arm will receive volixibat 20mg twice daily.
Participants randomized to this arm will receive volixibat 80mg twice daily.
Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily.
Outcomes
Primary Outcome Measures
Mean change in the daily itch scores using the Adult Itch Reported Outcome (Adult ItchRO) questionnaire
The Adult ItchRO is an 11-point NRS measurement of itch severity ranging from 0=no itch to 10=worst possible itch.
Secondary Outcome Measures
Proportion of participants with itch response using the Adult ItchRO
The incidence of adverse events
Changes in fasting serum bile acid levels
Changes in alanine transaminase
Changes in aspartate transaminase
Changes in alkaline phosphatase
Changes in bilirubin levels
Change in Primary Sclerosing Cholangitis-Specific Patient-Reported Outcome
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) fatigue questionnaire
The PROMIS® Fatigue questionnaire is a 5-point response scale. Respondents endorse each item using a 5-point response scale: Never, Rarely, Sometimes, Often, and Always.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) sleep disturbance questionnaire
The PROMIS® Sleep Disturbance in an 8-item measure that assesses quality of sleep, sleep depth, and restoration associated with sleep. It is a 5-point response scale, the specific response options vary by items. The first 4 items use response options that range from Not at all to Very much. The next 3 items use response options that range from Never to Always. The final item assesses sleep quality ranging from Very poor to Very good.
Full Information
NCT ID
NCT04663308
First Posted
November 17, 2020
Last Updated
September 5, 2023
Sponsor
Mirum Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04663308
Brief Title
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
Acronym
VISTAS
Official Title
A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients With Primary Sclerosing Cholangitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2020 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mirum Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease progression of PSC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sclerosing Cholangitis
Keywords
Pruritus, PSC, Itch, Itching, Cholestasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Volixibat 20mg
Arm Type
Experimental
Arm Description
Participants randomized to this arm will receive volixibat 20mg twice daily.
Arm Title
Volixibat 80mg
Arm Type
Experimental
Arm Description
Participants randomized to this arm will receive volixibat 80mg twice daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily.
Intervention Type
Drug
Intervention Name(s)
Volixibat
Other Intervention Name(s)
SHP626
Intervention Description
Oral capsules, administered twice daily. Volixibat is an Ileal Bile Acid Transporter (IBAT) inhibitor.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules matched to study drug minus active substance
Primary Outcome Measure Information:
Title
Mean change in the daily itch scores using the Adult Itch Reported Outcome (Adult ItchRO) questionnaire
Description
The Adult ItchRO is an 11-point NRS measurement of itch severity ranging from 0=no itch to 10=worst possible itch.
Time Frame
Baseline through to Week 28
Secondary Outcome Measure Information:
Title
Proportion of participants with itch response using the Adult ItchRO
Time Frame
Baseline through to Week 28
Title
The incidence of adverse events
Time Frame
Baseline through to Week 28
Title
Changes in fasting serum bile acid levels
Time Frame
Baseline through to Week 28
Title
Changes in alanine transaminase
Time Frame
Baseline through to Week 28
Title
Changes in aspartate transaminase
Time Frame
Baseline through to Week 28
Title
Changes in alkaline phosphatase
Time Frame
Baseline through to Week 28
Title
Changes in bilirubin levels
Time Frame
Baseline through to Week 28
Title
Change in Primary Sclerosing Cholangitis-Specific Patient-Reported Outcome
Time Frame
Baseline through to Week 28
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) fatigue questionnaire
Description
The PROMIS® Fatigue questionnaire is a 5-point response scale. Respondents endorse each item using a 5-point response scale: Never, Rarely, Sometimes, Often, and Always.
Time Frame
Baseline through to Week 28
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) sleep disturbance questionnaire
Description
The PROMIS® Sleep Disturbance in an 8-item measure that assesses quality of sleep, sleep depth, and restoration associated with sleep. It is a 5-point response scale, the specific response options vary by items. The first 4 items use response options that range from Not at all to Very much. The next 3 items use response options that range from Never to Always. The final item assesses sleep quality ranging from Very poor to Very good.
Time Frame
Baseline through to Week 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provide freely signed informed consent and assent (as applicable) and be willing to comply with all study visits and requirements through end of study, including the follow-up period.
Subjects aged ≥16 years for eligible regions
Confirmed diagnosis of large duct or small duct PSC based on American Association for the Study of Liver Disease (AASLD) guidelines.
Qualified pruritus associated with PSC as assessed by Adult ItchRO.
Ursodeoxycholic acid (UDCA) and anti-pruritic medication use will be allowed if meeting additional criteria.
Concomitant Inflammatory Bowel Disease (IBD) is allowed if meeting additional criteria.
Exclusion Criteria:
Pruritus associated with an etiology other than PSC
Evidence or clinical suspicion of decompensated cirrhosis, or a history of decompensation events
History of ileostomy or small bowel surgery/resection or other surgeries that may have disrupted the enterohepatic circulation
Evidence, history, or suspicion of other liver diseases
Bile duct stent or percutaneous bile duct drain placement, or balloon dilatation procedure of a stricture within 12 weeks of Screening
Exceeding pre-defined biochemical values for alanine aminotransferase/aspartate aminotransferase (ALT/AST), estimated glomerular filtration rate (eGFR),serum creatinine (sCr), platelet count, international normalized ratio (INR) and total bilirubin
History of liver transplantation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials Mirum
Phone
+16506674085
Email
clinicaltrials@mirumpharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Medinfo Mirum
Email
medinfo@mirumpharma.com
Facility Information:
Facility Name
Southern California Research Center
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kasey Seyer
Phone
619-522-0330
Email
kseyer@researchscrc.com
First Name & Middle Initial & Last Name & Degree
Tarek Hassanein, MD
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walid Ayoub, MD
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Ruiz
Phone
916-734-2911
Email
mmruiz@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Christopher Bowlus, MD
Facility Name
California Pacific Medical Center Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Nguyen
Phone
415-600-5708
Email
nguyel18@sutterhealth.org
First Name & Middle Initial & Last Name & Degree
Kidist Yimam, MD
Facility Name
University of Colorado - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Forman, MD
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noor Matar
Email
Noor.N.Matar@medstar.net
First Name & Middle Initial & Last Name & Degree
Coleman Smith
Facility Name
Florida Research Institute
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Murphy
Email
ana.murphy@fdhs.com
First Name & Middle Initial & Last Name & Degree
Souvik Sarkar, MD, PhD
Facility Name
University of Miami - Schiff Center for Liver Diseases
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katheryn Dae
Email
kqd1@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Cynthia Levy, MD
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Schmidt
Phone
813-347-2878
Email
jenniferanilsen@tgh.org
First Name & Middle Initial & Last Name & Degree
Nyingi Kemmer
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Shea
Phone
617-632-1129
Email
jmshea@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Alan Bonder, MD
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelley Tamburo
Phone
313-916-1967
Email
ktambur2@hfhs.org
First Name & Middle Initial & Last Name & Degree
Stuart Gordon, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clayton Mitchell
Phone
507-284-2698
Email
clayton.mitchell@mayo.edu
First Name & Middle Initial & Last Name & Degree
John Eaton, MD
Facility Name
Southern Therapy and Advanced Research LLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Terminated
Facility Name
Northwell Health
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Terminated
Facility Name
New York University Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Surjya Bhattacharrya
Email
surjya.bhattacharyya@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Ira M. Jacobson, MD
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jhané Phanor
Phone
646-962-5370
Email
jhp4004@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Emily Schonfeld, MD
Facility Name
Columbia University Irving Medical Center - Research Pharmacy
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliva Woodford-Berry
Phone
212-305-3839
Email
ow2191@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Mercedes Martinez
Facility Name
University of Rochester Medical Center - Strong Memorial Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Terminated
Facility Name
Duke Health - Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adele Gaskin
Phone
919-684-0742
Email
adele.gaskin@duke.edu
First Name & Middle Initial & Last Name & Degree
Julius Wilder, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Kruszewski
Phone
216-636-5555
Email
kruszek@ccf.org
First Name & Middle Initial & Last Name & Degree
Olumuyiwa Awoniyi, MD
Facility Name
Einstein Healthcare Network - Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manish Thapar, MD
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Grubich
Phone
412-647-1461
Email
grubichhl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Mordechai Rabinovitz, MD
Facility Name
Galen Medical Group
City
Hixson
State/Province
Tennessee
ZIP/Postal Code
37343
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sydney Boles
Phone
423-308-0280
Email
Sydney.Boles@galenmedical.com
First Name & Middle Initial & Last Name & Degree
Chirag Patel
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn Campbell
Phone
615-343-5683
Email
kathryn.e.campbell@vumc.org
First Name & Middle Initial & Last Name & Degree
Roman Perri, MD
Facility Name
The Liver Institute At Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uyen Pham
Phone
219-947-1287
Email
UyenPham@mhd.com
First Name & Middle Initial & Last Name & Degree
Parvez Mantry, MD
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marlyn Mayo, MD
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Hinton
Phone
346-238-4460
Email
nhinton@houstonmethodist.org
First Name & Middle Initial & Last Name & Degree
David Victor III, MD
Facility Name
Liver Associates of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Ankoma-Sey
Facility Name
University of Utah Health Care
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie McDonough
Email
Stephanie.Mcdonough@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Juan Gallegos-Orozco, MD
Facility Name
Bon Secours Liver Institution of Hampton Roads Mary Immaculate Hospital Office
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23603
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Rhodes
Phone
757-947-3191
Email
Sarah_rhodes@bshsi.org
First Name & Middle Initial & Last Name & Degree
Mitchell Shiffman, MD
Facility Name
Richmond Community Hospital LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Joines
Phone
804-977-8921
Email
Laura_Joines@bshsi.org
First Name & Middle Initial & Last Name & Degree
Mitchell Shiffman, MD
Facility Name
University of Washington - Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Terminated
Facility Name
Liver Institute Northwest
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inga Avagyan
Email
iavagyan@liverinstitutenw.org
First Name & Middle Initial & Last Name & Degree
Kris Kowdley, MD
Facility Name
The Ottawa Hospital - General Campus
City
Ottawa
State/Province
Ontario
Country
Canada
Individual Site Status
Terminated
Facility Name
University Health Network - Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ambreen Syeda
Phone
416-480-4800
Ext
2654
Email
Ambreen.Syeda@uhnresearch.ca
First Name & Middle Initial & Last Name & Degree
Gideon Hirschfield, MD
Facility Name
Hannover Medical School
City
Hannover
State/Province
Lower Saxony
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heiner Wedemeyer, Prof.
Email
Wedemeyer.Heiner@mh-hannover.de
First Name & Middle Initial & Last Name & Degree
Heiner Wedemeyer, Prof.
Facility Name
Universitaetsklinikum Bonn
City
Bonn
State/Province
Nordrhine-Westphalia
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadine Köstlmeier
Phone
49(0)228 28715260
Email
Nadine.Koestlmeier@ukbonn.de
First Name & Middle Initial & Last Name & Degree
Leona Dold, MD
Facility Name
Charité Universtitätsmedizin - Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Kanter
Phone
030450630074
Email
marco.kanter@charite.de
First Name & Middle Initial & Last Name & Degree
Münevver Demir
Facility Name
Universitaetsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Terminated
Facility Name
Universitätsklinikum Schleswig-Holstein - Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rainer Günther, MD
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tony Herta
Facility Name
University Hospital Tubingen Medical Clinic
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Berg, Prof. Dr. med.
Facility Name
St. Josefs-Hospital Wiesbaden
City
Wiesbaden
ZIP/Postal Code
65189
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Durmashkina
Email
edurmashkina@joho.de
First Name & Middle Initial & Last Name & Degree
Christoph Sarrazin, Prof.
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rimma Kramskay
Email
rimma_k@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Ella Veitsman, MD
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
3434104
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eli Zuckerman, MD
Phone
+97248250053
Email
EliZuc@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Eli Zuckerman, MD
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gadi Lalazar, MD
Phone
972507484591
Email
gadil@szmc.org.il
First Name & Middle Initial & Last Name & Degree
Gadi Lalazar, MD
Facility Name
Hadassah Medical Center - Ein Karem
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reem Dakkak
Phone
972-2-6777451
Email
Reemk@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Rifaat Safadi
Facility Name
Galilee Medical Center
City
Nahariyya
ZIP/Postal Code
2210001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nimer Assy, MD
Phone
+972 (0) 4-6828442
Email
nimera@gmc.gov.il
First Name & Middle Initial & Last Name & Degree
Nimer Assy, MD
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marius Braun, Dr.
Phone
97239377252
Email
mariusa@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Marius Braun, Dr.
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziv Ben-Ari, Prof.
Phone
+972 3 5307177
Email
ziv.ben-ari@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Ziv Ben-Ari, Prof.
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ehud Zigmond, Dr.
Phone
972-36973984
Email
zigmond@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Ehud Zigmond, Dr.
Facility Name
Royal Free Hospital
City
London
State/Province
Hampstead
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
General Email
Email
rt-tr.hepatologyresearch@nhs.net
First Name & Middle Initial & Last Name & Degree
Douglas Thorburn
Facility Name
John Radcliffe Hospital
City
Oxford
State/Province
Headington
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Sennett
Phone
01865 221575
Email
Christine.Sennett@ouh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Emma Culver, MD
Facility Name
Royal Victoria Hospital
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roger McCorry, MD
Phone
02896156199
Email
roger.mccorry@belfasttrust.hscni.net
First Name & Middle Initial & Last Name & Degree
Roger McCorry, MD
Facility Name
University Hospitals Birmingham NHS Foundation Trust - Wellcome Trust Birmingham Clinical Research Facility
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Hull
Phone
+44 121 371 8463
Email
Diana.Hull@uhb.nhs.uk
First Name & Middle Initial & Last Name & Degree
Palak Trivedi
Facility Name
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abigail Ford
Phone
01223 274604
Email
abigail.ford4@nhs.net
First Name & Middle Initial & Last Name & Degree
George Mells
Facility Name
Lothian NHS Board
City
Edinburgh
ZIP/Postal Code
EH164SA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Hayes, Prof
Email
Peter.Hayes@nhslothian.scot.nhs.uk
First Name & Middle Initial & Last Name & Degree
Peter Hayes, Prof.
Facility Name
St James' University Hospital Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Suspended
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Ayers
Phone
02032997615
Email
andrew.ayers@nhs.net
First Name & Middle Initial & Last Name & Degree
Deepask Joshi, MD
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
General Email
Email
HepatologyResearch@uhs.nhs.uk
First Name & Middle Initial & Last Name & Degree
Janisha Patel, MD
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
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