Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B study: HRS-5635 Injection
Official title Phase III Study of HRS-5635 in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B
ClinicalTrials.gov ID: NCT07606950
What this study is testing
What is HRS-5635 Injection?
This is an investigational injectable medicine being studied as a potential treatment for chronic hepatitis B.
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.
- Who it's for
- People with chronic hepatitis B whose virus is already controlled by a daily pill.
- What's involved
- Participants take a daily pill and get an injection or a fake shot (placebo) every few months, plus regular blood tests.
- Time commitment
- The study lasts up to 2 years, including visits for screening, treatment, and follow-up.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening;
- Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation;
- HBeAg negative at screening;
- On commercially available NAs monotherapy for at least 24 weeks before randomization, and the dosing regimen remained unchanged for at least 4 weeks...
- Need to take effective contraceptive measures；
You likely can't join if
- History of cirrhosis or clinical evidence of hepatic decompensation, confirmed or suspected liver cancer, with other liver diseases other than...
- With autoimmune disease;
- History of solid organ transplantation or hematopoietic stem cell transplantation;
- Clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;
- Malignant tumors were diagnosed within 5 years prior to randomization；
- Major trauma or major surgery within the 12 weeks prior to randomization, or surgical plans or other treatment during the study period which the...
See the full eligibility criteria
- Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening;
- Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation;
- HBeAg negative at screening;
- 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;
- Need to take effective contraceptive measures；
- Volunteer to sign an informed consent.
- 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;
- With autoimmune disease;
- History of solid organ transplantation or hematopoietic stem cell transplantation;
- Clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;
- Malignant tumors were diagnosed within 5 years prior to randomization；
- 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;
- Laboratory tests during the screening period were obviously abnormal;
- Prolonged ECG QTcF or other clinically significant abnormal results that may pose a significant safety risk to the subject during the screening period;
- History of drug use, alcohol or drug abuse in the 12 months prior to randomization;
- Participated in clinical study of other drugs (received experimental drugs);
- Pregnant or nursing women;
- Allergic to a drug ingredient or component;
- Other reasons for ineligibility as judged by the investigators.
The study team makes the final eligibility decision.
Where it is enrolling
- Guangzhou, Guangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Guangzhou, Guangzhou, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.