Phase III Study of HRS-5635 in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B

Fujian Shengdi Pharmaceutical

Status and phase: Not yet enrolling; Phase 3

Conditions: Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B

Treatments: Drug: Placebo; Drug: HRS-5635 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07606950

HRS-5635-301

Details and patient eligibility

About

This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and immunogenicity of HRS-5635 injection as compared to the placebo arm in nucleos(t)ide analogue-suppressed HBeAg-negative patients with chronic hepatitis B. The total duration of the study, including screening (up to 4 weeks), the double-blind treatment stage (60 weeks) and the off-treatment follow-up (24 weeks), is up to approximately 88 weeks at maximum for each participant.

Enrollment: 540 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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540 participants in 2 patient groups, including a placebo group

HRS-5635 Injection

Experimental group

Treatment:

Drug: HRS-5635 Injection

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo