Back to resultsA Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis (VANTAGE)
Primary Purpose
Primary Biliary Cholangitis, PBC
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 Biliary Cholangitis focused on measuring Pruritus, PBC, Itching, Cholangitis, Primary Biliary Cholangitis, Hepatobiliary disorders
Eligibility Criteria
Inclusion Criteria:
- Provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study
- Male or female, age ≥18 years at the screening visit
- Confirmed diagnosis of PBC in line with the AASLD guidelines
- UDCA and anti-pruritic medication use will be allowed if meeting additional criteria
- Qualified pruritus associated with PBC as assessed by Adult ItchRO
Exclusion Criteria:
- Pruritus associated with an etiology other than PBC
- Evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events
- Current symptomatic cholelithiasis or inflammatory gallbladder disease
- History of small bowel surgery/resection impacting the terminal ileum that may disrupt the enterohepatic circulation.
- Evidence, history, or suspicion of other liver diseases
Sites / Locations
- Southern California Research CenterRecruiting
- Cedars Sinai Medical CenterRecruiting
- University of ColoradoRecruiting
- Covenant Metabolic SpecialistsRecruiting
- UF Hepatology Research at CTRBRecruiting
- UF Health Gastroenterology- EmersonRecruiting
- IHS HealthRecruiting
- Schiff Center for Liver DiseasesRecruiting
- Advanced Research Institute, IncRecruiting
- Covenant Research and Clinics, LLCRecruiting
- Tampa General HospitalRecruiting
- Southeast Clinical Research CenterRecruiting
- Northwestern UniversityRecruiting
- Loyola University Health System - Loyola Outpatient CenterRecruiting
- University of Iowa Hospitals & ClinicsRecruiting
- Ochsner Clinic Foundation-Baton RougeRecruiting
- LSU Health Science Center ShreveportRecruiting
- Beth Israel DeaconessRecruiting
- Mayo ClinicRecruiting
- Jackson Liver and GI SpecialistsRecruiting
- CHI Health Clinic (Alegent Creighton Clinic)- Gastroenterology-BerganRecruiting
- Cleveland Clinic - Main CampusRecruiting
- Einstein Healthcare Network - Einstein Medical CenterRecruiting
- Methodist Le Bonheur HealthcareRecruiting
- Galen Medical Group, P.CRecruiting
- Amel Med LLCRecruiting
- Soma Clinical TrialsRecruiting
- Liver Associates of TexasRecruiting
- Impact ResearchRecruiting
- University of Utah Health CareRecruiting
- MedStar Health Research InstituteRecruiting
- Bon Secours Liver Institute of Hampton Roads Mary Immaculate HospitalRecruiting
- Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of RichmondRecruiting
- Liver Institute NorthwestRecruiting
- CHU Grenoble - Hôpital MICHALLONRecruiting
- Hopital Claude Huriez-Digestive system disease clinicRecruiting
- CHU de NICE- Hospital L'Archet 2Recruiting
- Hospital Saint AntoineRecruiting
- Nouvel Hospital CivilRecruiting
- Hospital Paul Brousse- APHPRecruiting
- Klinikum Chemnitz gGmbHRecruiting
- Universitätsklinikum Frankfurt am MainRecruiting
- Universitätsklinikum Schleswig-HolsteinRecruiting
- University Hospital Tübingen Medical clinicRecruiting
- St. Josefs-Hospital WiesbadenRecruiting
- Rambam Medical CenterRecruiting
- Carmel Medical CenterRecruiting
- Shaare Zedek Medical CenterRecruiting
- Hadassah Medical Center - Ein Karem, Liver Institute Kiryat Hadassah POB 12000Recruiting
- Galilee Medical CenterRecruiting
- Rabin Medical CenterRecruiting
- Sheba Medical CenterRecruiting
- The Tel Aviv Sourasky Medical CenterRecruiting
- Fondazione Ca GrandaRecruiting
- Istituto Clinico HumanitasRecruiting
- Belfast Health & Social Care Trust (BHSCT) Royal Victoria HospitalRecruiting
- King's College Hospital NHS Foundation TrustRecruiting
- Nottingham University Hospitals NHS 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
Incidence of adverse events
Changes in aspartate aminotransferase
Changes in alanine aminotransferase
Changes in alkaline phosphatase
Changes in total bilirubin
Changes in direct bilirubin
Changes in fasting serum bile acid levels
Change in Primary Biliary Cholangitis Quality of Life Measure (PBC-40)
PBC-40 questionnaire is scored on a scale of 40 to 200, with higher scores indicating poorer quality of life
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
NCT05050136
First Posted
September 9, 2021
Last Updated
October 3, 2023
Sponsor
Mirum Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05050136
Brief Title
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
Acronym
VANTAGE
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 Biliary Cholangitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2021 (Actual)
Primary Completion Date
December 2023 (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 Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cholangitis, PBC
Keywords
Pruritus, PBC, Itching, Cholangitis, Primary Biliary Cholangitis, Hepatobiliary disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
260 (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 without the active pharmaceutical ingredient
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 to week 28
Secondary Outcome Measure Information:
Title
Proportion of participants with itch response using the Adult ItchRO
Time Frame
Baseline to week 28
Title
Incidence of adverse events
Time Frame
Baseline to week 28
Title
Changes in aspartate aminotransferase
Time Frame
Baseline to week 28
Title
Changes in alanine aminotransferase
Time Frame
Baseline to week 28
Title
Changes in alkaline phosphatase
Time Frame
Baseline to week 28
Title
Changes in total bilirubin
Time Frame
Baseline to week 28
Title
Changes in direct bilirubin
Time Frame
Baseline to week 28
Title
Changes in fasting serum bile acid levels
Time Frame
Baseline to week 28
Title
Change in Primary Biliary Cholangitis Quality of Life Measure (PBC-40)
Description
PBC-40 questionnaire is scored on a scale of 40 to 200, with higher scores indicating poorer quality of life
Time Frame
Baseline 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 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 to week 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study
Male or female, age ≥18 years at the screening visit
Confirmed diagnosis of PBC in line with the AASLD guidelines
UDCA and anti-pruritic medication use will be allowed if meeting additional criteria
Qualified pruritus associated with PBC as assessed by Adult ItchRO
Exclusion Criteria:
Pruritus associated with an etiology other than PBC
Evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events
Current symptomatic cholelithiasis or inflammatory gallbladder disease
History of small bowel surgery/resection impacting the terminal ileum that may disrupt the enterohepatic circulation.
Evidence, history, or suspicion of other liver diseases
Facility Information:
Facility Name
Southern California Research Center
City
Coronado
State/Province
California
ZIP/Postal Code
92218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kasey Seyer
Phone
619-522-0330
Ext
122
Email
kasey@researchscrc.com
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
Nirosha Tilakaratna
Phone
310-423-1269
Email
Nirosha.Tilakaratna@cshs.org
First Name & Middle Initial & Last Name & Degree
Kevin Yashar
Phone
310-423-2743
Email
Kevin.Yashar@cshs.org
Facility Name
University of Colorado
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
Charles Stasa
Phone
303-724-6875
Email
Charles.stasa@cuanschutx.edu
Facility Name
Covenant Metabolic Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy Neff, MD
Phone
941-500-3200
Email
Guy.neff@covresearch.com
First Name & Middle Initial & Last Name & Degree
Julia Surow
Phone
941-500-3200
Email
Julia.surow@covresearch.com
Facility Name
UF Hepatology Research at CTRB
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lasheaka McClellan
Phone
352-273-7285
Email
Lasheaka.mcclellan@medicine.ufl.edu
Facility Name
UF Health Gastroenterology- Emerson
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maged Ghali, MD
Phone
904-633-0070
Email
Maged.ghali@jax.ufl.edu
First Name & Middle Initial & Last Name & Degree
Kelly Jackman
Phone
904-633-0070
Email
Kelly.jackman@jax.ufl.edu
Facility Name
IHS Health
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natasha Contreras
Phone
407-530-4370
Email
ncontreras@ihshealths.com
Facility Name
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
Edisson Jesus Aguilera
Phone
305-243-4648
Email
eja103@med.miami.edu
Facility Name
Advanced Research Institute, Inc
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Tyson
Phone
727-835-3261
Email
christina.arel@ariclinical.com
Facility Name
Covenant Research and Clinics, LLC
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronica Valle
Phone
941-500-3200
Email
veronica.valle@covresearch.com
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, RN, BSN
Phone
813-347-2878
Email
Jenniferanilsen@tgh.org
Facility Name
Southeast Clinical Research Center
City
Dalton
State/Province
Georgia
ZIP/Postal Code
30720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alma Carmona
Phone
706-913-1779
Email
acarmona@scresearchcenter.com
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanne Gottstein
Phone
312-694-0264
Email
j-gottstein@northwestern.edu
Facility Name
Loyola University Health System - Loyola Outpatient Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vira Boichuk
Phone
708-216-3268
Email
vboichuk@luc.edu
First Name & Middle Initial & Last Name & Degree
Michelle Kudulis
Phone
708-216-0291
Email
mkudulis@luc.edu
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jena Valestin, RN, BSN
Phone
319-353-4574
Email
jessica-valestin@uiowa.edu
Facility Name
Ochsner Clinic Foundation-Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70836
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magen Parker
Phone
225-791-5278
Email
Magen.parker@ochsner.org
Facility Name
LSU Health Science Center Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robyne Champagne
Phone
318-675-5803
Email
Robyne.champagne@lsuhs.edu
Facility Name
Beth Israel Deaconess
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
617-632-1125
Email
jmshea@bidmc.harvard.edu
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
Mitchell Clayton
Phone
507-284-2698
Email
clayton.mitchell@mayo.edu
Facility Name
Jackson Liver and GI Specialists
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Seals
Phone
769-251-5674
Ext
18
Email
nseals@jacksonliverandgi.com
Facility Name
CHI Health Clinic (Alegent Creighton Clinic)- Gastroenterology-Bergan
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madeline Esch
Phone
402-343-8511
Email
Maddie.esch@commonspirit.org
Facility Name
Cleveland Clinic - Main Campus
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
Erin McMullen
Phone
216-636-5555
Email
mcmulle@ccf.org
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
Laura Clark
Phone
215-456-8721
Email
laura.clark@jefferson.edu
Facility Name
Methodist Le Bonheur Healthcare
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol Jones, RN,B.S.N
Phone
901-516-8078
Email
carol.jones@mlh.org
Facility Name
Galen Medical Group, P.C
City
Tennessee
State/Province
Tennessee
ZIP/Postal Code
37343
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Norwood
Phone
423-954-9015
Email
kim.norwood@galenmedical.com
First Name & Middle Initial & Last Name & Degree
Sydney Boles
Phone
423-954-9015
Facility Name
Amel Med LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan Smith, MD
Phone
512-718-7415
Email
msmith@mkhccs.com
Facility Name
Soma Clinical Trials
City
Denison
State/Province
Texas
ZIP/Postal Code
75020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Hassan
Phone
469-819-0228
Email
admin@somaclinicaltrials.com
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
Quynh-An Phan
Phone
713-799-2667
Email
aphan@liverassoctx.com
Facility Name
Impact Research
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Canada Canada
Phone
254-294-4780
Email
ncanada@impactresearchtx.com
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
Amy Holman
Phone
801-538-0689
Email
amy.holman@hsc.utah.edu
Facility Name
MedStar Health Research Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Jin
Phone
202-877-6501
Email
joohyun.g.jin@medstar.net
Facility Name
Bon Secours Liver Institute of Hampton Roads Mary Immaculate Hospital
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naketa Bartlett
Phone
757-947-3197
Email
Naketa_bartlett@bshsi.org
Facility Name
Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond
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
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
Theresa Dorrian
Phone
206-536-3030
Email
tdorrian@liverinstitutenw.org
Facility Name
CHU Grenoble - Hôpital MICHALLON
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Vige
Phone
33 4 76 76 67 45
Email
evige@chu-grenoble.fr
Facility Name
Hopital Claude Huriez-Digestive system disease clinic
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chadly Charron
Phone
03.20.44.57.42
Email
chadly.charron@chru-lille.fr
Facility Name
CHU de NICE- Hospital L'Archet 2
City
Nice
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katia De Cuyper
Phone
33 4 92 03 66 31
Email
de-cuyper.k@chu-nice.fr
Facility Name
Hospital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farid Gaouar
Phone
33-1-71-97-01-17
Email
farid.gaouar@aphp.fr
Facility Name
Nouvel Hospital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline Simo-Noumbissie
Phone
33-3 69 55 16 80
Email
pauline.simo-noumbissie@chru-strasbourg.fr
Facility Name
Hospital Paul Brousse- APHP
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roua Ben Hassine
Phone
33 1 45 59 64 23
Email
roua.benhassine-ext@aphp.fr
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacqueline Uhle
Phone
+49 (0)371-333 35631
Email
juhle@skc.de
Phone
+49 (0)371-333 33236
Facility Name
Universitätsklinikum Frankfurt am Main
City
Frankfurt
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Gesell
Phone
069-6301-87769
Email
Laura.Gesell@kgu.de
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonja Rohweder
Phone
+4943150022406
Email
Sonja.Rohweder@uksh.de
First Name & Middle Initial & Last Name & Degree
Vanessa Maerz
Phone
+4943150022406
Email
vanessa.maerz@uksh.de
Facility Name
University Hospital Tübingen Medical clinic
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petra Janke-Maier
Phone
+ 49 7071 29-82130
Email
Petra.Janke-Maier@med.uni-tuebingen.de
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
Johanna Bedford
Phone
+49 611 177 4271
Email
jbedford@joho.de
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 Kramsky
Phone
+972-50-2063188
Email
rimma_k@rmc.gov.il
First Name & Middle Initial & Last Name & Degree
Vered Ben-Hakoon
Phone
+972-50-2061650
Email
v_ben-hakoon@rambam.health.gov.il
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
Hen Biton
Phone
+972-4-8250052
Email
LiverAll1@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Orly Azulay
Phone
+972-4-8250685
Email
orlyaz@clalit.org.il
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
Laura Atlan
Phone
+972-2-6555467
Email
lauraat@szmc.org.il
First Name & Middle Initial & Last Name & Degree
Johanna Fitusi
Phone
+972-2-6555467
Email
johannafi@szmc.org.il
Facility Name
Hadassah Medical Center - Ein Karem, Liver Institute Kiryat Hadassah POB 12000
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rana Marzeeq
Phone
972-52-5128438
Email
ranama@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Reem Kaloti Dakkak
Phone
972-54-3059284
Email
reemk@hadassah.org.il
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
Nelly Bar Guy
Phone
+972-527476202
Email
nellyb@gmc.gov.il
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
Daniel Ofri
Phone
+972-3-652-5104
Email
danielof@clalit.org.il
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
Hadar Jenin
Phone
+972-35307179
Email
Hadar.Jenin@sheba.health.gov.il
Facility Name
The 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
Ayelet Sela
Phone
+972-509033371
Email
ayeletse@tlvmc.gov.il
Facility Name
Fondazione Ca Granda
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberta Soffredini
Phone
0250320378
Email
Roberta.soffredini@policlinico.mi.it
Facility Name
Istituto Clinico Humanitas
City
Rozzano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilaria Sogno
Phone
00390282247319
Email
Ilaria.sogno@humanitas.it
Facility Name
Belfast Health & Social Care Trust (BHSCT) 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
Heather Lawther
Phone
02896150497
Email
Heather.lawther@belfasttrust.hscni.net
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
020322997148
Email
andrew.ayers@nhs.net
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Henry
Phone
+44 1159249924
Ext
83711
Email
Suzanne.Henry2@nuh.nhs.uk
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 Biliary Cholangitis
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