RECRUITING

Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goals of this clinical study are to first learn more about safety and dosing of the study drug GS-4321 in healthy participants. The study will then learn about the safety and effectiveness of GS-4321 in participants with chronic hepatitis delta (CHD). The primary objective of Phase 1 of this study to evaluate the safety, tolerability and Pharmacokinetics (PK) of the escalating single doses of GS-4321 administered in healthy participants. The primary objective of Phase 2 of this study is to evaluate the efficacy and safety of the multiple escalating doses of GS-4321 in participants with CHD.

Official Title

Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta

Quick Facts

Study Start:2025-07-31
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07096193

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
  2. * Have a body mass index (BMI) of ≤ 30.0 kg/m2 at screening and at admission.
  3. * Participants assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
  4. * Chronic hepatitis delta (CHD) for ≥ 6 months prior to screening, documented by prior medical history.
  5. * Must be receiving a commercially available nucleoside/nucleotide analogue for the treatment of hepatitis B virus (HBV) infection at enrollment.
  6. * Hepatitis delta virus ribonucleic acid (HDV RNA ) \> 100 IU/mL at screening.
  7. * Alanine aminotransferase (ALT) level \> 1 × Upper limit of normal (ULN), but \< 10 × ULN at screening.
  1. * Positive serum or urine pregnancy test.
  2. * Participants with plans to breastfeed during the study period.
  3. * Positive serum or urine pregnancy test.
  4. * Participants with plans to breastfeed during the study period.
  5. * Current or previous clinically decompensated liver disease, including coagulopathy, hepatic encephalopathy, and esophageal varices hemorrhage due to HDV or HBV.
  6. * Child-Turcotte-Pugh (CTP)-B or -C or a CTP score of ≥ 7.

Contacts and Locations

Study Contact

Gilead Clinical Study Information Center
CONTACT
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com

Principal Investigator

Gilead Study Director
STUDY_DIRECTOR
Gilead Sciences

Study Locations (Sites)

Investigative Site
Anaheim, California, 92801
United States

Collaborators and Investigators

Sponsor: Gilead Sciences

  • Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-31
Study Completion Date2028-12

Study Record Updates

Study Start Date2025-07-31
Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Hepatitis Delta