Recruiting NCT07606950
Phase III Study of HRS-5635 in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-5635 Injection, Placebo.
- Who it may be relevant to
- Registry conditions: Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-designed Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS-5635 Injection in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B
Overview
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)，NAs-only treatment stage（12 weeks） and the off-treatment follow-up (24 weeks), is up to approximately 100 weeks at maximum for each participant.
Interventions
- Drug HRS-5635 Injection
HRS-5635 Injection, administered by subcutaneous injection; - Drug Placebo
Placebo, administered by subcutaneous injection.
Primary outcome measures
- Percentage of participants with sustained HBV DNA suppression and HBsAg loss within 24 weeks after discontinuation of all HBV therapy [Time frame: 24 weeks after discontinuation of all CHB treatment]
Secondary outcome measures (12)
- Percentage of participants with sustained HBV DNA suppression and HBsAg < 100 IU/mL [Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
- Percentage of participants with sustained HBV DNA suppression and HBsAg < 10 IU/mL [Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
- Percentage of participants with sustained HBV DNA suppression [Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
- Percentage of participants with HBsAg < 100 IU/mL [Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
- Percentage of participants with HBsAg < 10 IU/mL [Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
- Changes from baseline in mean log10 HBsAg levels [Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
- Percentage of participants with HBsAg loss [Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
- Percentage of participants with HBsAg seroconversion [Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
- Percentage of participants with HBeAb positive [Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
- Percentage of participants with virologic breakthrough [Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
- Percentage of participants with drug resistance [Time frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
- Percentage of participants who meet the criteria for stopping nucleos(t)ide analogue (NA) therapy [Time frame: Week 72 and Week 96]
Eligibility criteria
Inclusion 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Nanfang Hospital, Southern Medical University — Guangzhou
Identifiers
NCT: NCT07606950 · HRS-5635-301