HRS-5635 in people with chronic hepatitis B who are suppressed on nucleos(t)ide analogues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind phase 3 trial comparing HRS-5635 injections to placebo in adults with chronic hepatitis B who are virologically suppressed on nucleos(t)ide analogue therapy and are HBeAg-negative. Participants undergo a screening period, a 60-week double-blind treatment phase, a 12-week NAs-only treatment phase, and a 24-week off-treatment follow-up, for up to about 100 weeks total. Primary outcomes include efficacy signals such as virologic response and safety, along with pharmacokinetics and immunogenicity assessments. The study is conducted at a single site in Guangzhou, with Fujian Shengdi Pharmaceutical Co., Ltd. as lead sponsor. Clinical trial procedures include regular safety monitoring and laboratory testing throughout.

Why it matters

Who can join: the full rules

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.

Where it's running

• Nanfang Hospital, Southern Medical University
  Guangzhou, Guangzhou, China Recruiting

Study contacts

• Study coordinator: Xiaopeng Wang
• Email: xiaopeng.wang@hengrui.com
• Phone: 0518-82342973

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• HRS-4729 and HRS9531 injections in adults with MASH

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.