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
- 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.
- 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
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2027-01-19
- First posted
- 2024-05-22
- Registry last updated
- 2025-11-17
- Primary completion date
- 2026-08-30
- Start date
- 2024-06-06
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06425341
- ClinicalTrials.gov ID
- NCT06425341
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
PartA：Change in mean log10 serum hepatitis B surface antigen levels from baseline at week 12
Timeframe: Week 12
PartB：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48
Timeframe: Week 48
PartC：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48
Timeframe: Week 48
PartD：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48
Timeframe: Week 48
Changes from baseline in mean log10 serum hepatitis B surface antigen levels
Timeframe: Pre-specified time points up to 72 weeks
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
Proportion of subjects with serum hepatitis B surface antigen loss
Timeframe: Pre-specified time points up to 72 weeks
Proportion of subjects with serum hepatitis B surface antigen seroconversion
Timeframe: Pre-specified time points up to 72 weeks
Proportion of subjects with hepatitis B e-antigen loss
Timeframe: Pre-specified time points up to 72 weeks
Proportion of subjects with serum hepatitis B e-antigen seroconversion
Timeframe: Pre-specified time points up to 72 weeks
Proportion of subjects with virologic breakthrough
Timeframe: Pre-specified time points up to 72 weeks
Proportion of subjects with drug resistance
Timeframe: Pre-specified time points up to 72 weeks
Proportion of subjects who meet the criteria for stopping NA therapy
Timeframe: From 48 weeks to 72 weeks
Proportion of subjects with serum hepatitis B surface antigen loss and HBV DNA loss
Timeframe: Week 48
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- Meet the body mass index standard greater than or equal to 18.5 kg/m2 and less than 35 kg/m2;
- 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;
- 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；
- Infection requiring intervention within 2 weeks 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.
- Nanfang HospitalGuangzhou, ChinaRecruiting
Related records
Drugs (4)
Lead sponsors (1)
Conditions (2)
- Chronic hepatitis B virus infection
- Hepatitis B virus infection Primary condition