Back to resultsStudy to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis (PACIFIC)
Primary Purpose
Pruritus
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
EP547
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pruritus focused on measuring Pruritus, Itch, Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, PACIFIC, EP547
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 80 years
- Documented primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC)
- Presence of consistent moderate to severe pruritus
- Use of anti-pruritic and anti-cholestatic (including UDCA and obeticholic acid) medication allowed if meeting additional criteria
- Individuals with concomitant inflammatory bowel disease must meet additional relevant criteria
Exclusion Criteria:
- Pruritus associated with an etiology other than PBC or PSC
- Prior or planned liver transplantation
- Evidence of compensated or decompensated cirrhosis
- Alternative causes of liver disease
- Presence of documented secondary sclerosing cholangitis
- Current evidence of clinically significant high-grade strictures or presence of biliary stent
- History of significant small bowel resection or short bowel syndrome
- Has exclusionary laboratory or biochemical results at Screening
Sites / Locations
- University of Alabama Birmingham HospitalRecruiting
- Dignity Health Center for Clinical Research at St. Joseph HospitalRecruiting
- Southern California Research CenterRecruiting
- Science 37Recruiting
- California Liver Research InstituteRecruiting
- University of Miami - Schiff Center for Liver DiseasesRecruiting
- University of Iowa Hospitals & ClinicsRecruiting
- Tulane University Health Sciences CenterRecruiting
- Massachusetts General HospitalRecruiting
- University of MinnesotaRecruiting
- Southern Therapy and Advanced Research
- Montefiore Medical CenterRecruiting
- NYU Grossman School of Medicine Gastroenterology and HepatologyRecruiting
- Gastro Health ResearchRecruiting
- University Hospitals Cleveland Medical CenterRecruiting
- UPMC Center for Liver DiseaseRecruiting
- The Liver Institute at Methodist Dallas Medical CenterRecruiting
- Liver Associates of Texas, PARecruiting
- Gastro Health & NutritionRecruiting
- Bon Secours Liver Institute of VirginiaRecruiting
- UZ AntwerpenRecruiting
- UZ GentRecruiting
- UZ LeuvenRecruiting
- (G.I.R.I.) GI Research InstituteRecruiting
- Toronto Centre for Liver Disease Toronto General HospitalRecruiting
- Centre hospitalier de l'Université de Montréal (CHUM)Recruiting
- APHP AvicenneRecruiting
- CHU Grenoble- Alpes- Site NordRecruiting
- CHU de LilleRecruiting
- Saint Antoine HospitalRecruiting
- Hospital RangueilRecruiting
- Paul Brousse HospitalRecruiting
- Carmel Medical CenterRecruiting
- Rambam Medical Center- Keriat Eliezer Family Health CenterRecruiting
- Hadassah Medical Center (Ein-Karem)Recruiting
- Chaim Sheba Medical CenterRecruiting
- Academic Medical Center- University of AmsterdamRecruiting
- Hospital General Universitario AlicanteRecruiting
- Hospital Clinic BarcelonaRecruiting
- Hospital de MonteceloRecruiting
- Campus Hospital Universitario Virgen del RocioRecruiting
- La Fe University and Polytechnic HospitalRecruiting
- Hospital Universitario Miguel ServetRecruiting
- University Hospitals Birmingham NHS Foundation TrustRecruiting
- Glasgow Royal InfirmaryRecruiting
- King's College Hospital NHS Foundation TrustRecruiting
- Institute of Cellular Medicine, Newcastle UniversityRecruiting
- Norfolk and Norwich University Hospitals NHS Foundation TrustRecruiting
- University of Nottingham - Nottingham Digestive Diseases Centre Biomedical Research UnitRecruiting
- University Hospitals Plymouth NHS Trust - Derriford HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
EP547 100 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in Worst Itch Numeric Rating Scale (WI-NRS)
Pruritus will be measured using a WI-NRS scale to indicate the intensity of itch in the past 24 hours from 0 (No Itching) to 10 (Worst Itching Imaginable)
Secondary Outcome Measures
Change in 5-D Itch Scale
The 5-D Itch Scale will be used to measure change in pruritus covering five dimensions: degree, duration, direction, disability, and distribution. The total 5-D Itch Scale score ranges from 5 to 25, with higher scores indicating worse quality of life
Proportion of subjects with improvement in pruritus as defined by PGI-C
Change in pruritus will be measured using the PGI-C scale to indicate overall change in pruritus in the past 7 days compared to before treatment using a 7-point scale from much improved to much worse
Proportion of subjects with improvement in pruritus severity from baseline as defined by PGI-S
Pruritus will be measured using the PGI-S scale to indicate severity of itch in the past 7 days using a 4-point scale from none to severe
Proportion of subjects with a reduction in WI-NRS ≥2 from baseline
Pruritus will be measured using a WI-NRS scale to indicate the intensity of itch in the past 24 hours from 0 (No Itching) to 10 (Worst Itching Imaginable)
Proportion of subjects with a reduction in WI-NRS ≥3 from baseline
Pruritus will be measured using a WI-NRS scale to indicate the intensity of itch in the past 24 hours from 0 (No Itching) to 10 (Worst Itching Imaginable)
Proportion of subjects with a reduction in WI-NRS ≥4 from baseline
Pruritus will be measured using a WI-NRS scale to indicate the intensity of itch in the past 24 hours from 0 (No Itching) to 10 (Worst Itching Imaginable)
Proportion of subjects with WI-NRS <4
Pruritus will be measured using a WI-NRS scale to indicate the intensity of itch in the past 24 hours from 0 (No Itching) to 10 (Worst Itching Imaginable)
The incidence of adverse events
Safety and tolerability of EP547 measured through reporting of adverse events
Maximum Plasma Concentration [Cmax]
To evaluate the pharmacokinetics of EP547
Full Information
NCT ID
NCT05525520
First Posted
August 30, 2022
Last Updated
October 19, 2023
Sponsor
Escient Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT05525520
Brief Title
Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
Acronym
PACIFIC
Official Title
Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Escient Pharmaceuticals, Inc
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
This phase 2 trial will evaluate the effects of EP547 in subjects with cholestatic pruritus due to Primary Biliary Cholangitis (PBC) or Primary Sclerosing Cholangitis (PSC)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus
Keywords
Pruritus, Itch, Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, PACIFIC, EP547
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EP547 100 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
EP547
Intervention Description
Once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once daily
Primary Outcome Measure Information:
Title
Change in Worst Itch Numeric Rating Scale (WI-NRS)
Description
Pruritus will be measured using a WI-NRS scale to indicate the intensity of itch in the past 24 hours from 0 (No Itching) to 10 (Worst Itching Imaginable)
Time Frame
Measured from Baseline to Week 6
Secondary Outcome Measure Information:
Title
Change in 5-D Itch Scale
Description
The 5-D Itch Scale will be used to measure change in pruritus covering five dimensions: degree, duration, direction, disability, and distribution. The total 5-D Itch Scale score ranges from 5 to 25, with higher scores indicating worse quality of life
Time Frame
Measured from Baseline to Week 6
Title
Proportion of subjects with improvement in pruritus as defined by PGI-C
Description
Change in pruritus will be measured using the PGI-C scale to indicate overall change in pruritus in the past 7 days compared to before treatment using a 7-point scale from much improved to much worse
Time Frame
Measured at Week 6
Title
Proportion of subjects with improvement in pruritus severity from baseline as defined by PGI-S
Description
Pruritus will be measured using the PGI-S scale to indicate severity of itch in the past 7 days using a 4-point scale from none to severe
Time Frame
Measured from Baseline to Week 6
Title
Proportion of subjects with a reduction in WI-NRS ≥2 from baseline
Description
Pruritus will be measured using a WI-NRS scale to indicate the intensity of itch in the past 24 hours from 0 (No Itching) to 10 (Worst Itching Imaginable)
Time Frame
Measured from Baseline to Week 6
Title
Proportion of subjects with a reduction in WI-NRS ≥3 from baseline
Description
Pruritus will be measured using a WI-NRS scale to indicate the intensity of itch in the past 24 hours from 0 (No Itching) to 10 (Worst Itching Imaginable)
Time Frame
Measured from Baseline to Week 6
Title
Proportion of subjects with a reduction in WI-NRS ≥4 from baseline
Description
Pruritus will be measured using a WI-NRS scale to indicate the intensity of itch in the past 24 hours from 0 (No Itching) to 10 (Worst Itching Imaginable)
Time Frame
Measured from Baseline to Week 6
Title
Proportion of subjects with WI-NRS <4
Description
Pruritus will be measured using a WI-NRS scale to indicate the intensity of itch in the past 24 hours from 0 (No Itching) to 10 (Worst Itching Imaginable)
Time Frame
Measured from Baseline to Week 6
Title
The incidence of adverse events
Description
Safety and tolerability of EP547 measured through reporting of adverse events
Time Frame
Measured from Day 1 to End of Study or Early Termination (up to Week 6)
Title
Maximum Plasma Concentration [Cmax]
Description
To evaluate the pharmacokinetics of EP547
Time Frame
Measured from Day 1 to Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 to 80 years
Documented primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC)
Presence of consistent moderate to severe pruritus
Use of anti-pruritic and anti-cholestatic (including UDCA and obeticholic acid) medication allowed if meeting additional criteria
Individuals with concomitant inflammatory bowel disease must meet additional relevant criteria
Exclusion Criteria:
Pruritus associated with an etiology other than PBC or PSC
Prior or planned liver transplantation
Evidence of compensated or decompensated cirrhosis
Alternative causes of liver disease
Presence of documented secondary sclerosing cholangitis
Current evidence of clinically significant high-grade strictures or presence of biliary stent
History of significant small bowel resection or short bowel syndrome
Has exclusionary laboratory or biochemical results at Screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Escient Clinical Trials
Phone
858-617-8220
Email
clinicaltrials@escientpharma.com
Facility Information:
Facility Name
University of Alabama Birmingham Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alesha Matthews
Phone
205-996-4744
Email
aleshamatthews@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Sujan Ravi, MD
Facility Name
Dignity Health Center for Clinical Research at St. Joseph Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serena Stewart
Phone
602-406-3109
Email
serena.stewart@commonspirit.org
First Name & Middle Initial & Last Name & Degree
Justin Reynolds, MD
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
619-826-8767
Email
kasey@researchscrc.com
First Name & Middle Initial & Last Name & Degree
Tarek Hassanein, MD
Facility Name
Science 37
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patient Experience Coordinator (PEC)
Phone
855-235-3143
Email
pruritus@science37.com
First Name & Middle Initial & Last Name & Degree
Emily Crockett, MD
Facility Name
California Liver Research Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Tang
Phone
626-795-5769
Email
stephanie.tang@caliverresearch.org
First Name & Middle Initial & Last Name & Degree
Edward Mena, MD
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
Felisa Carmen Padila
Phone
305-243-4615
Email
fcp25@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Cynthia Levy, MD
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 Neuhaus
Phone
319-335-0123
Email
jena-neuhaus@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Antonio Sanchez, MD
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elaine Boos
Phone
504-988-1346
Email
eboos@tulane.edu
First Name & Middle Initial & Last Name & Degree
Fredrick Regenstein, MD
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duru Cosar
Phone
617-726-2000
Email
dcosar@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Daniel Pratt, MD
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Rajala
Phone
612-624-8511
Email
srajala@umn.edu
First Name & Middle Initial & Last Name & Degree
John Lake, MD
Facility Name
Southern Therapy and Advanced Research
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Withdrawn
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harith Raees
Phone
614-425-7407
Email
hraees@montefiore.org
First Name & Middle Initial & Last Name & Degree
Brett Fortune, MD
Facility Name
NYU Grossman School of Medicine Gastroenterology and Hepatology
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
Abigail Moses
Phone
646-501-8469
Email
abigail.moses@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Ira Jacobson, MD
Facility Name
Gastro Health Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Pairan
Phone
513-872-4549
Email
jpairan@gastrohealth.com
First Name & Middle Initial & Last Name & Degree
Ravi Ravinuthala, MD
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Northcutt
Phone
855-282-8997
Email
katherine.northcutt@uhhospitals.org
First Name & Middle Initial & Last Name & Degree
Seth Sclair, MD
Facility Name
UPMC Center for Liver Disease
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
Mary Beth Luce
Phone
412-647-1461
Email
lucem@upmc.edu
First Name & Middle Initial & Last Name & Degree
Mordechai Rabinovitz, 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
Lainne Carey
Phone
214-947-4400
Email
Lainnecarey@mhd.com
First Name & Middle Initial & Last Name & Degree
Parvez Mantry, MD
Facility Name
Liver Associates of Texas, PA
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
Muhammad Bilal Zia
Phone
713-799-2667
Email
research@liverassoctx.com
First Name & Middle Initial & Last Name & Degree
Victor Ankoma-Sey, MD
Facility Name
Gastro Health & Nutrition
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Ghouse
Phone
713-429-4550
Email
perceptivepharmaresearch@gmail.com
First Name & Middle Initial & Last Name & Degree
Dharmendra Verma, MD
Facility Name
Bon Secours Liver Institute of Virginia
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
UZ Antwerpen
City
Antwerpen
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sven V Franque
Email
studies.hepatologie@uza.be
First Name & Middle Initial & Last Name & Degree
Sven V Franque, MD
Facility Name
UZ Gent
City
Gent
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Roels
Phone
+32 09 33 20333
Email
karen.roels@uzgent.be
First Name & Middle Initial & Last Name & Degree
Xavier Verhelst, MD
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lesley Cockmartin
Phone
+32 16 341690
Email
lesley.cockmartin@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Jef Verbeek, MD
Facility Name
(G.I.R.I.) GI Research Institute
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leo Yammaoto
Phone
604-688-6332
Email
leoy@giribc.com
First Name & Middle Initial & Last Name & Degree
Hin Hin Ko, MD
Facility Name
Toronto Centre for Liver Disease Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ambreen Syeda
Phone
416-480-4800
Email
ambreen.syeda@uhnresearch.ca
First Name & Middle Initial & Last Name & Degree
Gideon Hirschfield, MD
Facility Name
Centre hospitalier de l'Université de Montréal (CHUM)
City
Montreal
State/Province
Quebeck
ZIP/Postal Code
H2X 0A9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cassandra Ouellet-Deneault
Phone
514 890-8000
Email
cassandra.ouellet.deneault.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Julian Hercun, MD
Facility Name
APHP Avicenne
City
Bobigny
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
accueil.hepato.avc@aphp.fr
First Name & Middle Initial & Last Name & Degree
Nathalie Ganne-Carrie, MD
Facility Name
CHU Grenoble- Alpes- Site Nord
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Vigé
Phone
04 76 76 67 45
Email
evige@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Marie-Noelle Hilleret, MD
Facility Name
CHU de Lille
City
Lille
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@chu-lille.fr
First Name & Middle Initial & Last Name & Degree
Alexandre Louvet, MD
Facility Name
Saint Antoine Hospital
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Corpechot, MD
Phone
33 1 49 28 28 36
Email
christophe.corpechot@aphp.fr
First Name & Middle Initial & Last Name & Degree
Christophe Corpechot, MD
Facility Name
Hospital Rangueil
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Alric, MD
Phone
33 5 61 32 36 66
Email
alric.l@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Laurent Alric, MD
Facility Name
Paul Brousse Hospital
City
Villejuif
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roua Ben Hassine
Phone
01 45 59 64 23
Email
roua.benhassine-ext@aphp.fr
First Name & Middle Initial & Last Name & Degree
Audrey Coilly, MD
Facility Name
Carmel Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azulay Orly
Phone
+97248250053
Email
orlyaz@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Eli Zuckerman, MD
Facility Name
Rambam Medical Center- Keriat Eliezer Family Health Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vered Hakoon
Phone
+97247771415
Email
v_ben-hakoon@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Ella Veitsman, MD
Facility Name
Hadassah Medical Center (Ein-Karem)
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suha Sandouka
Phone
+9720587497939
Email
Shuha@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Rifaat Safadi, MD
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziv Ben-Ari, MD
Phone
+97235307177
Email
Ziv.Ben-Ari@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Ziv Ben-Ari, MD
Facility Name
Academic Medical Center- University of Amsterdam
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diedrick van Doorn
Phone
+31 20 566 8468
Email
d.j.vandoorn@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Ulrich Beuers, MD
Facility Name
Hospital General Universitario Alicante
City
Alicante
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Bellot Garcia
Phone
+34965933464
Email
pablobellot.garcia@gmail.com
First Name & Middle Initial & Last Name & Degree
Pablo Bellot Garcia, MD
Facility Name
Hospital Clinic Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Carlota Londono
Phone
+34932275400
Email
mlondono@clinic.cat
First Name & Middle Initial & Last Name & Degree
Maria Carlota Londono, MD
Facility Name
Hospital de Montecelo
City
Pontevedra
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Indhira Perez Medrano
Phone
+34986800907
Email
indhira.miosotis.perez.medrano@sergas.es
First Name & Middle Initial & Last Name & Degree
Indhira Perez Medrano, MD
Facility Name
Campus Hospital Universitario Virgen del Rocio
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Arques Mascort
Phone
+34955012065
Email
sara.mascort@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
Javier Ampuero, MD
Facility Name
La Fe University and Polytechnic Hospital
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Berenguer
Phone
+34961245856
Email
marina.berenguer@uv.es
First Name & Middle Initial & Last Name & Degree
Marina Berenguer, MD
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanesa Bernal Monterde
Phone
+34 610 913 521
Email
vbernalm@gmail.com
First Name & Middle Initial & Last Name & Degree
Vanesa Bernal Monterde, MD
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Palak Trivedi, MD
Phone
+44 0121 371 4188
Email
palak.trivedi@uhb.nhs.uk
First Name & Middle Initial & Last Name & Degree
Palak Trivedi, MD
Facility Name
Glasgow Royal Infirmary
City
Glasgow
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Barclay, MD
Phone
+44 1412016383
Email
stephen.barclay@ggc.scot.nhs.uk
First Name & Middle Initial & Last Name & Degree
Stephen Barclay, MD
Facility Name
King's College Hospital NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deepak Joshi, MD
Phone
+44 2032997615
Email
d.joshi@nhs.net
First Name & Middle Initial & Last Name & Degree
Deepak Joshi, MD
Facility Name
Institute of Cellular Medicine, Newcastle University
City
Newcastle
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Jones, MD
Phone
+44 1912087572
Email
david.jones@ncl.ac.uk
First Name & Middle Initial & Last Name & Degree
David Jones, MD
Facility Name
Norfolk and Norwich University Hospitals NHS Foundation Trust
City
Norwich
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Rushbrook
Phone
+44 160 328 7725
Email
simon.rushbrook@nnuh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Simon Rushbrook, MD
Facility Name
University of Nottingham - Nottingham Digestive Diseases Centre Biomedical Research Unit
City
Nottingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suresh Venkatachalapath
Phone
+44(0)115 924 9924
Email
suresh.venkatachalapathy@nuh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Suresh Venkatachalapath, MD
Facility Name
University Hospitals Plymouth NHS Trust - Derriford Hospital
City
Plymouth
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Sheridan, MD
Phone
+44 1752432722
Email
david.sheridan2@nhs.net
First Name & Middle Initial & Last Name & Degree
David Sheridan, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
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