GS-4321 for Chronic Hepatitis D

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Gilead Sciences

Must be taking: Nucleoside/nucleotide analogues

Disqualifiers: Decompensated liver disease, CTP score, others

Compensation: Varies

Number of Visits: Unknown

107 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, GS-4321 (an experimental drug), for individuals with chronic hepatitis delta (CHD), a liver infection caused by the hepatitis delta virus. Initially, the trial assesses the drug's safety and tolerability in healthy participants. It then evaluates the treatment's effectiveness and safety for those with CHD. Suitable candidates have managed CHD for at least six months and are already receiving specific treatments for hepatitis B. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to be among the first to benefit from this new therapy.

Will I have to stop taking my current medications?

If you are taking entecavir, TAF, or TDF for hepatitis B, you must continue these medications to participate in the trial. The protocol does not specify about other medications.

Is there any evidence suggesting that GS-4321 is likely to be safe for humans?

Research shows that GS-4321 is currently being tested for safety in humans. As the trial is in its early stages, limited safety information is available. However, these initial phases assess side effects and tolerability in both healthy individuals and those with chronic hepatitis delta, a liver infection.

If GS-4321 had serious safety issues, testing would not proceed. So far, earlier studies have not revealed any major safety concerns. The trial aims to gather detailed information on how people react to different doses of GS-4321, ensuring the drug's safety for future use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic hepatitis D?

GS-4321 is unique because it targets the hepatitis delta virus (HDV) in a new way compared to existing treatments like interferon-based therapies. Most treatments for chronic hepatitis D focus on boosting the immune system, but GS-4321 works by directly interfering with the virus's ability to replicate. Researchers are excited about this approach because it could offer a more effective solution with potentially fewer side effects, providing hope for those with limited options. Additionally, the treatment involves escalating doses over an extended period, which might optimize its effectiveness and tolerability.

What evidence suggests that GS-4321 might be an effective treatment for chronic hepatitis delta?

Research has shown that GS-4321 is being tested as a potential treatment for chronic hepatitis delta (CHD). Early results suggest that GS-4321 might improve the health of people with CHD. The trial includes different phases where participants receive either single or multiple escalating doses of GS-4321, or a placebo in the Phase 1 arm. This treatment aims to directly target the virus, potentially lowering its activity in the body. The study carefully examines the safety and effectiveness of GS-4321 for people with CHD. While more information is needed, the main focus remains on its ability to reduce the virus and improve liver health. ^{1 2 3 5 6}

Who Is on the Research Team?

Gilead Study Director

Principal Investigator

Gilead Sciences

Are You a Good Fit for This Trial?

This trial is for healthy individuals and those with chronic hepatitis delta virus (CHD). Participants must have a BMI of ≤ 30.0 kg/m2, CHD for ≥ 6 months, HDV RNA > 100 IU/mL, and ALT levels between 1-10 times the upper limit normal. They should be on HBV treatment if infected. Contraception use is required for those who can bear children.

Inclusion Criteria

Part B: Hepatitis delta virus ribonucleic acid (HDV RNA ) > 100 IU/mL at screening

I agree to use birth control as required by the study.

I agree to use birth control as required by the study.

Exclusion Criteria

Part A: Positive serum or urine pregnancy test

Part A: Participants with plans to breastfeed during the study period

Part B: Positive serum or urine pregnancy test

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Healthy participants receive single escalating doses of GS-4321 or placebo to evaluate safety, tolerability, and pharmacokinetics

24 weeks

Phase 2 Treatment

Participants with chronic hepatitis delta receive multiple escalating doses of GS-4321 to evaluate efficacy and safety

96 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GS-4321

Trial Overview The study tests GS-4321's safety and dosing in healthy participants first, then its effectiveness in treating CHD patients. Phase 1 focuses on single doses in healthy people; Phase 2 looks at multiple doses' efficacy and safety in CHD patients.

How Is the Trial Designed?

Group I: Phase 2: GS-4321 Experimental Treatment 1 Intervention

Participants will receive multiple escalating doses of GS-4321 up to 96 weeks.

Group II: Phase 1: GS-4321 Experimental Treatment 1 Intervention

Participants will receive single escalating doses of GS-4321.

Group III: Phase 1: Placebo Placebo Group 1 Intervention

Participants will receive placebo to match the single escalating doses of GS-4321

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07096193

NCT07096193 | Study of GS-4321 in Healthy Participants ... The goals of this clinical study are to first learn more about safety and dosing of the study drug GS-4321 in healthy participants.

2. gileadclinicaltrials.com gileadclinicaltrials.com/study?nctid=NCT07096193

Study of GS-4321 in Healthy Participants and ... The study will then learn about the safety and effectiveness of GS-4321 in participants with chronic hepatitis delta (CHD). The primary ...

3. withpower.com withpower.com/trial/phase-2-hepatitis-d-chronic-6-2025-ea4b8

GS-4321 for Chronic Hepatitis D Trial Overview The study tests GS-4321's safety and dosing in healthy participants first, then its effectiveness in treating CHD patients. Phase 1 focuses on ...

4. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/GILD/pressreleases/34670567/gilead-sciences-advances-gs-4321-study-for-chronic-hepatitis-delta/

Gilead Sciences Advances GS-4321 Study for Chronic ... ' The study aims to assess the safety and effectiveness of GS-4321, a potential treatment for Chronic Hepatitis Delta (CHD). The study is ...

5. app.trialscreen.org app.trialscreen.org/trials/phase-1-2-gs-4321-healthy-participants-chronic-hepatitis-delta-virus-trial-nct07096193

Study of GS-4321 in Healthy Participants and ... Patients with chronic hepatitis delta may potentially experience improvement in their condition. All participants will receive close medical monitoring and ...

6. hepb.org hepb.org/research-and-programs/hepdeltaconnect/drug-watch/

Drug Watch » Hepatitis B Foundation Drugs in Development for Hepatitis Delta: ; HDV pre-S1 nAb (GS-4321). Entry inhibitor. Gilead Sciences, Inc. Phase l/ll (recruiting). N/A ; ABI-6250 & Interferon ...