New shot aims to silence hepatitis b virus for good
NCT ID NCT07606950
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This study tests an experimental injection called HRS-5635 in adults with chronic hepatitis B whose virus is already controlled by daily pills. The goal is to see if the injection can help the body clear the virus so patients can safely stop all hepatitis B medications. About 540 participants will receive either HRS-5635 or a placebo for 60 weeks, then be monitored for 24 more weeks after stopping treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 540 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2026
- Expected to finish
-
Jun 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening; 2. Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation; 3. HBeAg negative at screening; 4. On commercially available NAs monotherapy for at least 24 weeks before randomization, and the dosing regimen remained unchanged for at least 4 weeks before randomization; 5. Need to take effective contraceptive measures; 6. Volunteer to sign an informed consent. Exclusion Criteria: 1. History of cirrhosis or clinical evidence of hepatic decompensation, confirmed or suspected liver cancer, with other liver diseases other than chronic hepatitis B that may affect the evaluation of the study; 2. With autoimmune disease; 3. History of solid organ transplantation or hematopoietic stem cell transplantation; 4. Clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases; 5. Malignant tumors were diagnosed within 5 years prior to randomization; 6. Major trauma or major surgery within the 12 weeks prior to randomization, or surgical plans or other treatment during the study period which the investigators determined may influence the evaluation of the study results; 7. Laboratory tests during the screening period were obviously abnormal; 8. Prolonged ECG QTcF or other clinically significant abnormal results that may pose a significant safety risk to the subject during the screening period; 9. History of drug use, alcohol or drug abuse in the 12 months prior to randomization; 10. Participated in clinical study of other drugs (received experimental drugs); 11. Pregnant or nursing women; 12. Allergic to a drug ingredient or component; 13. Other reasons for ineligibility as judged by the investigators.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic hepatitis B are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Nanfang Hospital, Southern Medical University
RECRUITINGGuangzhou, Guangzhou, 510515, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Massive Real-World database aims to map how chronic diseases interact
- Can a Two-Drug combo wipe out hepatitis b for good?
- Can a new pill push hepatitis b virus to undetectable levels?
- Can a newer hepatitis b drug protect babies while being gentler on their bones?
- CRISPR 'Brake Release' may reawaken immune cells to beat hepatitis b
- Can a vaccine teach the immune system to fight hepatitis b?