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New treatment option for Chronic Hepatitis Delta
Official title Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus
ClinicalTrials.gov ID: NCT07096193
What this study is testing
What is GS-4321?
GS-4321 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for chronic hepatitis delta.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 69. Healthy volunteers may be eligible.
You may be able to join if
- Key Part A:
- Participants assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use...
- Have a body mass index (BMI) of ≤ 30.0 kg/m2 at screening and at admission. Part B:
- Participants assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use...
- Chronic hepatitis delta (CHD) for ≥ 6 months prior to screening, documented by prior medical history.
You likely can't join if
- Part A:
- Positive serum or urine pregnancy test.
- Participants with plans to breastfeed during the study period. Part B:
- Positive serum or urine pregnancy test.
- Participants with plans to breastfeed during the study period.
- Current or previous clinically decompensated liver disease, including coagulopathy, hepatic encephalopathy, and esophageal varices hemorrhage due to...
See the full eligibility criteria
- Key Part A:
- 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.
- Have a body mass index (BMI) of ≤ 30.0 kg/m2 at screening and at admission. Part B:
- 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.
- Chronic hepatitis delta (CHD) for ≥ 6 months prior to screening, documented by prior medical history.
- Must be receiving a commercially available entecavir, TAF, or TDF for the treatment of hepatitis B virus (HBV) infection at or prior to enrollment. Coformulation as part of a fixed-dose combination for the treatment of...
- Non-cirrhotic or compensated cirrhosis.
- Hepatitis delta virus ribonucleic acid (HDV RNA ) \> 500 IU/mL at screening.
- Alanine aminotransferase (ALT) level \> 1 × Upper limit of normal (ULN), but \< 10 × ULN at screening. Key
- Part A:
- Positive serum or urine pregnancy test.
- Participants with plans to breastfeed during the study period. Part B:
- Positive serum or urine pregnancy test.
- Participants with plans to breastfeed during the study period.
- Current or previous clinically decompensated liver disease, including coagulopathy, hepatic encephalopathy, and esophageal varices hemorrhage due to HDV or HBV.
- Child-Turcotte-Pugh (CTP)-B or -C or a CTP score of ≥ 7. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Anaheim, California, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- New York, New York, United States
- Milan, Italy
- Chinsinau, Moldova
- Chisinau, Moldova
- Bucharest, Romania
- Iași, Romania
- Ansan-si, South Korea
- Bucheon-si, South Korea
- Seoul, South Korea
- Chiayi City, Taiwan
- Kaohsiung City, Taiwan
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 69 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anaheim, California, United States; Louisville, Kentucky, United States; Baltimore, Maryland, United States; New York, New York, United States; Milan, Italy; Chinsinau, Moldova and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.