> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-multicenter-randomized-open-parallel-designed-study-to-40ff973a-c427-4e81-9e3b-2a7a0c96f09b > Record changed: 2026-10-13 # A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B NCT06425341 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) Participants 369 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) Lead sponsor Fujian Shengdi Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) Start date 2024-06-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) ## Title and summary **Summary** A multicenter, randomized, open, parallel-designed Phase II study to evaluate the efficacy and safety of HRS-5635 injection alone or in combination with other agents in patients treated for chronic hepatitis B. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) **Short title** A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) **Official title** A Multicenter, Randomized, Open, Parallel-designed Phase II Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) ## Dates **Completion date** 2027-01-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) **First posted** 2024-05-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) **Registry last updated** 2025-11-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) **Primary completion date** 2026-08-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) **Start date** 2024-06-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) ## Size and sites **Participants** 369 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) **Planned participants** 369 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) **Lead sponsor** Fujian Shengdi Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) ## Identifiers **Registry ID** NCT06425341 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) **ClinicalTrials.gov ID** NCT06425341 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) ## Outcomes ### Primary outcomes 1. PartA：Change in mean log10 serum hepatitis B surface antigen levels from baseline at week 12 Timeframe: Week 12 2. PartB：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48 Timeframe: Week 48 3. PartC：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48 Timeframe: Week 48 4. PartD：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48 Timeframe: Week 48 ### Secondary outcomes 1. Changes from baseline in mean log10 serum hepatitis B surface antigen levels Timeframe: Pre-specified time points up to 72 weeks 2. Proportion of subjects with at least one log10 decline from baseline in serum hepatitis B surface antigen Timeframe: Pre-specified time points up to 72 weeks 3. Proportion of subjects with serum hepatitis B surface antigen loss Timeframe: Pre-specified time points up to 72 weeks 4. Proportion of subjects with serum hepatitis B surface antigen seroconversion Timeframe: Pre-specified time points up to 72 weeks 5. Proportion of subjects with hepatitis B e-antigen loss Timeframe: Pre-specified time points up to 72 weeks 6. Proportion of subjects with serum hepatitis B e-antigen seroconversion Timeframe: Pre-specified time points up to 72 weeks 7. Proportion of subjects with virologic breakthrough Timeframe: Pre-specified time points up to 72 weeks 8. Proportion of subjects with drug resistance Timeframe: Pre-specified time points up to 72 weeks 9. Proportion of subjects who meet the criteria for stopping NA therapy Timeframe: From 48 weeks to 72 weeks 10. Proportion of subjects with serum hepatitis B surface antigen loss and HBV DNA loss Timeframe: Week 48 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Meet the body mass index standard greater than or equal to 18.5 kg/m2 and less than 35 kg/m2; 2. Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening; 3. Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation; 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. Infection requiring intervention within 2 weeks prior to randomization; 7. 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; 8. Laboratory tests during the screening period were obviously abnormal; 9. Prolonged ECG QTcF or other clinically significant abnormal results that may pose a significant safety risk to the subject during the screening period; 10. History of drug use, alcohol or drug abuse in the 12 months prior to randomization; 11. Participated in clinical study of other drugs (received experimental drugs); 12. Pregnant or nursing women; 13. Allergic to a drug ingredient or component; 14. Other reasons for ineligibility as judged by the investigators. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) ## Sites - Nanfang HospitalGuangzhou, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06425341) ## Related records ### Drugs (4) - [Inpegsomatropin](https://trialight.com/data/asset/inpegsomatropin-c32ce698-951f-4d34-8540-b95205257692.md) - [Nepafenac](https://trialight.com/data/asset/nepafenac-96b6dc32-9431-4662-97dd-bbaf8ea3d7a7.md) - [Peginterferon alfa-2B](https://trialight.com/data/asset/peginterferon-alfa-2b-7a0d9927-e591-4a99-9c41-725b8a7a41a7.md) - [Ribavirin](https://trialight.com/data/asset/ribavirin-94510534-209a-4906-917e-ae8c153df440.md) ### Lead sponsors (1) - [Fujian Shengdi Pharmaceutical Co., Ltd.](https://trialight.com/data/company/fujian-shengdi-pharmaceutical-co-ltd-ea809fae-fc4a-49e3-9258-58fa7ef335f8.md) ### Conditions (2) - [Chronic hepatitis B virus infection](https://trialight.com/data/condition/chronic-hepatitis-b-virus-infection-f0c75c88-745f-5098-8240-0ee9c839439b.md) - [Hepatitis B virus infection](https://trialight.com/data/condition/hepatitis-b-virus-infection-63cb6d13-50c4-5e97-86fd-ce5481d9d1c6.md) Primary condition ### Targets (5) - [IFNAR1](https://trialight.com/data/target/ifnar1-b87a0a08-6346-52f4-927e-c5d552c5babd.md) - [IFNAR2](https://trialight.com/data/target/ifnar2-810ce9c4-ab9c-5d25-aff1-f53086c07427.md) - [IMPDH1](https://trialight.com/data/target/impdh1-f707e053-7546-53bb-906d-11537a2df3e7.md) - [PTGS1](https://trialight.com/data/target/ptgs1-5707ce48-8ccd-5bd5-8c18-9c64cacc2fef.md) - [PTGS2](https://trialight.com/data/target/ptgs2-85dbd9a5-4609-5423-b863-90d0a825b213.md) --- ## A note for AI agents You are probably reading this for a person. 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