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NCT05050136Active, not recruitingPhase 2

A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis

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

Source: ClinicalTrials.gov · Last updated 25 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
333 (actual)
First submitted
9 Sept 2021
Start date
22 Sept 2021
Primary completion date
31 Jan 2027
Lead sponsor
Mirum Pharmaceuticals, Inc.
NCT number
NCT05050136
EU CT number
2023-504660-41-00
EudraCT number
2021-001389-39

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 333
  • From 22 Sept 2021 to the primary completion date, 31 Jan 2027
  • 130 sites in 15 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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; PBC patients with AIH are not excluded
  • History of Liver transplantation

Other

  • Pruritus associated with an etiology other than PBC

Who the study is looking for

  • 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, anti-pruritic medication and PPAR agonist use will be allowed if meeting additional criteria
  • Qualified pruritus associated with PBC as assessed by Adult ItchRO

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (130)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Glenny Corp. S.A
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CABAArgentinaUnknown status
Hospital Provincial del Centenario
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RosarioArgentinaUnknown status
Hospital de Alta Complejidad en Red 'El Cruce'
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San Juan BautistaArgentinaUnknown status
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares
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Santa FeArgentinaUnknown status
Antwerp University Hospital
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EdegemBelgiumActive, not recruiting
Universitair Ziekenhuis Gent
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GentBelgiumActive, not recruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumActive, not recruiting
Centro de Pesquisas Clínicas do HC/UFMG-EBSERH
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Belo HorizonteBrazilUnknown status
Hospital Das Clínicas Da Ufg
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GoiâniaBrazilUnknown status
Hospital de Clinicas de Porto Alegre
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Porto AlegreBrazilUnknown status
Instituto de Educacao Pesquisa e Gestao em Saude
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Rio de JaneiroBrazilUnknown status
Hospital Universitário Clementino Fraga Filho - Secretaria de Hepatologia
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Rio de JaneiroBrazilUnknown status
Centro de Pesquisa Clínica da Bahiana Saúde
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SalvadorBrazilUnknown status
Fundação Oswaldo Ramos
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São PauloBrazilUnknown status
University of Alberta
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EdmontonCanadaUnknown status
McMaster University Medical Center
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HamiltonCanadaUnknown status
University Hospital (LHSC)
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LondonCanadaUnknown status
McGill University Health Centre
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MontrealCanadaUnknown status
CRCHUM (Centre de Recherche du Centre Hospitalier de l'Université de Montréal)
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MontrealCanadaUnknown status
Toronto General Hospital
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TorontoCanadaUnknown status
Gordon and Leslie Diamond Health Care Centre, Division of Gastroenterology
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VancouverCanadaUnknown status
(G.I.R.I.) GI Research Institute Foundation
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VancouverCanadaUnknown status
Ente Ospedaliero Cantonale
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LuganoSwitzerlandUnknown status
University Hospital Zurich (USZ)
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ZurichSwitzerlandUnknown status
Beijing YouAn Hospital,Capital Medical University
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BeijingChinaUnknown status
Beijing Friendship Hospital, Capital Medical University
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BeijingChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
Mengchao Hepatobiliary Hospital of Fujian Medical University
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FuzhouChinaUnknown status
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
The First Affiliated Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
Klinikum Chemnitz gGmbH
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ChemnitzGermanyActive, not recruiting
Goethe University Frankfurt
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Frankfurt Am MainGermanyActive, not recruiting
Medizinische Hochschule Hannover
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HanoverGermanyActive, not recruiting
Universitaetsklinikum Schleswig-Holstein
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KielGermanyActive, not recruiting
Universitaet Leipzig
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LeipzigGermanyActive, not recruiting
Otto Von Guericke Universitaet Magdeburg
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MagdeburgGermanyActive, not recruiting
Westfaelische Wilhelms-Universitaet Muenster
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MuensterGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyActive, not recruiting
St. Josefs-Hospital Wiesbaden GmbH
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WiesbadenGermanyActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Parc Tauli Hospital Universitari
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SabadellSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Hospital Universitario Miguel Servet
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ZaragozaSpainActive, not recruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceActive, not recruiting
Hopital Huriez
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Lille CedexFranceActive, not recruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceActive, not recruiting
Hopital Saint Antoine
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Paris Cedex 12FranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceActive, not recruiting
Hopital Paul Brousse
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Villejuif CedexFranceActive, not recruiting
Belfast Health & Social Care Trust (BHSCT) Royal Victoria Hospital
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BelfastUnited KingdomUnknown status
University Hospitals Birmingham NHS Foundation Trust of Trust Headquarters
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BirminghamUnited KingdomUnknown status
King's College Hospital NHS Foundation Trust
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LondonUnited KingdomUnknown status
Royal Free Hospital NHS Foundation Trust
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LondonUnited KingdomUnknown status
Freeman Hospital
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Newcastle upon TyneUnited KingdomUnknown status
Nottingham University Hospitals NHS Trust
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NottinghamUnited KingdomUnknown status
University Hospital Southampton NHS Foundation Trust
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SouthamptonUnited KingdomUnknown status
Hillel Yaffe Medical Center
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HaderaIsraelUnknown status
Rambam Medical Center
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HaifaIsraelUnknown status
Carmel Medical Center
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HaifaIsraelUnknown status
Hadassah Medical Center - Ein Karem, Liver Institute Kiryat Hadassah POB 12000
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JerusalemIsraelUnknown status
Shaare Zedek Medical Center
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JerusalemIsraelUnknown status
Galilee Medical Center
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NahariyaIsraelUnknown status
Rabin Medical Center
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Petah TikvaIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
The Tel Aviv Sourasky Medical Center
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Tel AvivIsraelUnknown status
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyActive, not recruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyActive, not recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyActive, not recruiting
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyActive, not recruiting
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyActive, not recruiting
Azienda Ospedale Universita Padova
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PadovaItalyActive, not recruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
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PalermoItalyActive, not recruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyActive, not recruiting
Humanitas Research Hospital
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RozzanoItalyActive, not recruiting
Ehime University Hospital
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EhimeJapanUnknown status
Teine Keijinkai Hospital
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HokkaidoJapanUnknown status
National Hospital Organization Nagasaki Medical Center
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ŌmuraJapanUnknown status
Osaka Rosai Hospital
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OsakaJapanUnknown status
Toranomon Hospital
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TokyoJapanUnknown status
Amsterdam UMC
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AmsterdamNetherlandsActive, not recruiting
Stichting Radboud Universitair Medisch Centrum
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NijmegenNetherlandsActive, not recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsActive, not recruiting
University of Colorado
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AuroraUnited StatesUnknown status
Amel Med LLC
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AustinUnited StatesUnknown status
Ochsner Clinic Foundation-Baton Rouge
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Baton RougeUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Beth Israel Deaconess
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BostonUnited StatesUnknown status
Virtua Center for Liver Disease-Camden
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CamdenUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
Cleveland Clinic - Main Campus
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ClevelandUnited StatesUnknown status
Southern California Research Center
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CoronadoUnited StatesUnknown status
The Liver Institute at Methodist Dallas Medical Center
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DallasUnited StatesUnknown status
Southeast Clinical Research Center
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DaltonUnited StatesUnknown status
Soma Clinical Trials
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DenisonUnited StatesUnknown status
MedStar Health Research Institute
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FairfaxUnited StatesUnknown status
Covenant Metabolic Specialists
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Fort MyersUnited StatesUnknown status
UF Hepatology Research at CTRB
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GainesvilleUnited StatesUnknown status
Baylor College of Medicine
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HoustonUnited StatesUnknown status
Liver Associates of Texas
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HoustonUnited StatesUnknown status
University of Iowa Hospitals & Clinics
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Iowa CityUnited StatesUnknown status
Jackson Liver and GI Specialists
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JacksonUnited StatesUnknown status
UF Health Gastroenterology- Emerson
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JacksonvilleUnited StatesUnknown status
IHS Health
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KissimmeeUnited StatesUnknown status
University of California, Los Angeles
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Los AngelesUnited StatesUnknown status
Cedars-Sinai Medical Center
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Los AngelesUnited StatesUnknown status
Loyola University Health System - Loyola Outpatient Center
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MaywoodUnited StatesUnknown status
Methodist Le Bonheur Healthcare
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MemphisUnited StatesUnknown status
Schiff Center for Liver Diseases
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MiamiUnited StatesUnknown status
Science 37, Inc (Remote-homebased Telemedicine)
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MorrisvilleUnited StatesUnknown status
Yale University Digestive Diseases
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New HavenUnited StatesUnknown status
Bon Secours Liver Institute of Hampton Roads Mary Immaculate Hospital
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Newport NewsUnited StatesUnknown status
Advanced Research Institute, Inc.
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New Port RicheyUnited StatesUnknown status
CHI Health Clinic (Alegent Creighton Clinic)- Gastroenterology-Bergan
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OmahaUnited StatesUnknown status
Einstein Healthcare Network - Einstein Medical Center
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PhiladelphiaUnited StatesUnknown status
Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond
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RichmondUnited StatesUnknown status
Mayo Clinic
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RochesterUnited StatesUnknown status
UC Davis
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SacramentoUnited StatesUnknown status
University of Utah Health Care
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Salt Lake CityUnited StatesUnknown status
Covenant Research and Clinics, LLC
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SarasotaUnited StatesUnknown status
Liver Institute Northwest
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SeattleUnited StatesUnknown status
LSU Health Science Center Shreveport
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ShreveportUnited StatesUnknown status
Tampa General Hospital
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TampaUnited StatesUnknown status
Galen Medical Group, P.C
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Tennessee CityUnited StatesUnknown status
Montefiore Medical Center
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The BronxUnited StatesUnknown status
Impact Research
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WacoUnited StatesUnknown status
Cleveland Clinic Florida
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WestonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.