A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Enanta Pharmaceuticals, Inc
Study ID
NCT03394924
Phase
PHASE2
Status
Completed

Conditions

  • Primary Biliary Cholangitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • EDP-305 1 mg — DRUG
    Two tablets daily for 12 weeks
  • EDP-305 2.5 mg — DRUG
    Two tablets daily for 12 weeks
  • Placebo — DRUG
    Two tablets daily for 12 weeks

Study Details

A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis

Key Dates

First listed
Jan 9, 2018
Start date
Dec 27, 2017
Status verified
Jun 2020
Primary completion
Dec 19, 2019
Completion
Jan 16, 2020

Study Design

Enrollment
68 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EDP-305 1 mg
    Subjects will take 2 tablets once a day orally for 12 weeks
  • Experimental: EDP-305 2.5 mg
    Subjects will take 2 tablets once a day orally for 12 weeks
  • Placebo Comparator: Placebo
    Subjects will take two tablets once a day orally for 12 weeks

Primary Outcome Measure

Percentage of Participants With At Least a 20% Reduction in Alkaline Phosphatase (ALP) or Normalization of ALP at Week 12 Compared to Baseline [ Time Frame: Baseline and Week 12 ]

Locations (40)

FacilityCityStateZIPSite coordinators
Digestive Health Specialists of the SoutheastDothanAlabama36305-
Arkansas Diagnostic CenterLittle RockArkansas72205-
Texas Clinical Research InstituteLittle RockArkansas76012-
Southern California Research CenterCoronadoCalifornia92118-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
California Liver Research InstituePasadenaCalifornia91105-
Pasadena Liver CenterPasadenaCalifornia91105-
Inland Empire Liver FoundationRialtoCalifornia92377-
California Pacific Medical CenterSan FranciscoCalifornia94115-
South Denver Gastroenterology - Swedish Medical Center OfficeEnglewoodColorado80113-
Yale School of MedicineNew HavenConnecticut06520-
Gastroenterology Consultants of ClearwaterClearwaterFlorida33756-3839-
Nature Coast Clinical ResearchInvernessFlorida34452-
University of Miami Leonard M. Miller School of MedicineMiamiFlorida33136-
Consultative GastroenterologyAtlantaGeorgia30312-
Northwestern UniversityChicagoIllinois60611-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
Louisiana Research CenterShreveportLouisiana71105-
Johns Hopkins UniversityBaltimoreMaryland21287-
Mercy Medical Center-McAuley PlazaBaltimoreMaryland21202-
Digestive Disease AssociatesCatonsvilleMaryland21228-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Henry Ford HospitalDetroitMichigan48377-
CHI HealthOmahaNebraska68124-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
Northwell HealthManhassetNew York11030-
Concorde Medical GroupNew YorkNew York10016-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Mount Sinai Beth IsrealNew YorkNew York10016-
Weill Cornell Medical CollegeNew YorkNew York10024-
Montefiore Medical Center - BronxThe BronxNew York10461-1925-
University of Pittsburgh Medical Center - Center for Liver DiseasePittsburghPennsylvania15213-
Liver Consultants of TexasDallasTexas76104-
The Liver Institute at Methodist Dallas Medical CenterDallasTexas75203-
Baylor Saint Luke's Medical CenterHoustonTexas77030-
American Research Corporation at the Texas Liver InstituteSan AntonioTexas78215-
Liver Institute of Virginia-BremoRichmondVirginia23602-
Swedish First Hill CampusSeattleWashington98104-
University of WashingtonSeattleWashington98195-6460-

Find similar trials in Dothan, AL

By research site
Digestive Health Specialists of the Southeast· Dothan, ALArkansas Diagnostic Center· Little Rock, ARTexas Clinical Research Institute· Little Rock, ARSouthern California Research Center· Coronado, CACedars-Sinai Medical Center· Los Angeles, CACalifornia Liver Research Institue· Pasadena, CA

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