A Phase 1/2 interventional study of GS-4321 in healthy participants and patients with chronic hepatitis delta

Study Description

A two-phase study testing the safety and effectiveness of an investigational drug GS-4321 for treating chronic hepatitis delta virus infection

Study Details

Registry ID:

NCT07096193

Conditions:

Chronic Hepatitis Delta

Phase:

Phase 1,Phase 2

Target Enrollment:

200 participants

Start Date:

July 31, 2025

Age Range:

18–69 years

Healthy Volunteers:

No

Study Locations (30 sites)

• Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, SC Gastroenterologia ed Epatologia
  MilanItaly, Italy
• University Multi-profile Hospital for Active Treatment "SofiaMed" 00D
  SofiaBulgaria, Bulgaria
• Koc University Medical Faculty Hospital
  IstanbulTurkey (Türkiye), Turkey (Türkiye)
• Istabul University-Cerrahpasa Faculty of Medicine Hospital
  IstanbulTurkey (Türkiye), Turkey (Türkiye)
• Infectious Diseases Institutul National De Boli Infectioase Prof. Matei Bals
  BucharestRomania, Romania
• Institutul National De Boli Infectioase Prof. Dr. Matei Bals
  BucharestRomania, Romania
• Fundatia Dr. Victor Babes
  BucharestRomania, Romania
• Ankara Bilkent City Hospital Universiteler Neighborhood, 1604th Street No: 9,
  AnkaraTurkey (Türkiye), Turkey (Türkiye)
• Ankara Bilkent City Hospital Oncology Hospital Universiteler Neighborhood
  AnkaraTurkey (Türkiye), Turkey (Türkiye)
• Hacettepe University Faculty of Medicine Hospital Hacettepe Neighborhood
  AnkaraTurkey (Türkiye), Turkey (Türkiye)
• Dicle University Faculty of Medicine
  DiyarbakrirTurkey (Türkiye), Turkey (Türkiye)
• Medizinische Hochschule Hannover, Address: Klinik für Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie
  HanoverGermany, Germany
• Medizinische Hochschule Hannover
  HanoverGermany, Germany
• Gastromedica S.R.L.
  IașiRomania, Romania
• PMSI Clinical Republican Hospital "Timofei Mosneaga"
  ChisinauMoldova, Moldova
• IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba"
  ChisinauMoldova, Moldova
• IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba"
  ChinsinauMoldova, Moldova
• The New York-Presbyterian Hospital
  New York, New YorkUnited States, United States
• University of Maryland, Institute of Human Virology, Clinical Research Unit
  Baltimore, MarylandUnited States, United States
• University of Louisville, Clinical Trials Unit
  Louisville, KentuckyUnited States, United States
• University of California, San Diego - Altman Clinical and Translational Research Institute
  La Jolla, CaliforniaUnited States, United States
• Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
  Kaohsiung CityTaiwan, Taiwan
• Kaohsiung Medical University Chung-Ho Memorial Hospital
  Kaohsiung CityTaiwan, Taiwan
• Investigative Site
  Anaheim, CaliforniaUnited States, United States
• Ditmanson Medical Foundation Chia-Yi Christian Hospital
  Chiayi CityTaiwan, Taiwan
• National Taiwan University Hospital
  TaipeiTaiwan, Taiwan
• Korea University Ansan Hospital
  Ansan-siSouth Korea, South Korea
• The Catholic University of Korea Bucheon St. Mary's Hospital
  Bucheon-siSouth Korea, South Korea
• Samsung Medical Center
  SeoulSouth Korea, South Korea
• The Catholic University of Korea, Seoul St. Mary's Hospital
  SeoulSouth Korea, South Korea

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