Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT07088133
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-28
First Post:
2025-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trials of the Hepatitis B Sandwich Combination Therapy for Treating Patients Infected With Hepatitis B Virus
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Study Overview
Official Title:
Clinical Trials of the Hepatitis B Sandwich Combination Therapy for Treating Patients Infected With Hepatitis B Virus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
* Primary objective: The main objective of this study is to assess the efficacy and safety of a sandwich combination therapy in patients who were infected with HBV or have undergone surgery for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC). The primary efficacy endpoints are HBsAg seroconversion rate (HBsAg disappearance and HBsAb appearance), and HCC recurrence rate at week 49. Secondary Objective: To evaluate the safety of the HBV sandwich combination therapy through various safety indicators. Safety Indicators as follows: 1) Vital Signs: Monitoring systolic and diastolic blood pressure, pulse, respiration, and body temperature; 2) Physical Examination: Comprehensive physical assessments during the study; 3) 12-lead Electrocardiogram: Conducted to monitor cardiac health; 4) Clinical Laboratory Tests: Including blood routine, urine routine, blood biochemistry (focusing on liver and kidney function), coagulation function; 5) Injection Site Reactions: Monitoring for any local adverse effects from injections; 6) Adverse Events (AEs) and Serious Adverse Events (SAEs): Documentation of any AEs or SAEs occurring during treatment.
* Study Design: This study comprises three distinct stages:
1. Screening Period (Weeks -4 to -1): 1) Informed consent will be obtained from participants; 2) Collect baseline data and perform various assessments which include: a) 12-lead ECG; b) Infectious disease screening; c) Blood biochemistry, routine blood, urine routine, coagulation function; d) Blood pregnancy test (for female subjects); e) Hepatitis B virus and serology examination; f) Antinuclear antibody testing; g) Imaging examinations.
2. Treatment Period (Weeks 1 to 25): 1) Patients will receive ongoing nucleoside analogue treatment (NAs) throughout this stage; 2) Administer subcutaneous injections of the HBV monoclonal antibody HT-102 weekly for a total of 4 weeks (300 mg each time); 3) After treatment with HT-102, HBV serological and virological assessments will occur; 4) If serum HBsAg is below 10 IU/mL, proceed with therapeutic hepatitis B vaccine FD-001 (60 µg each time) every 4 weeks for a total of 6 doses; 5) If HBsAg is not below 10 IU/mL post HT-102, participants will enter the follow-up period directly.
3. Follow-up Phase (Weeks 25 to 49): 1) Continue with original nucleoside analogue treatment for HBV; 2) Conduct follow-up visits every 12 weeks; 3) Each visit will involve recording vital signs, conducting physical examinations, ECG, laboratory tests (as noted in safety indicators), and testing for HBV and immunological parameters.
* End of Study:
The study concludes once the follow-up of the last enrolled subject is completed, analyzing the collected data to evaluate efficacy and safety endpoints.
\- Note: Careful monitoring and adherence to protocols will be maintained to ensure participant safety and integrity of study data.
* Study Design: This study comprises three distinct stages:
1. Screening Period (Weeks -4 to -1): 1) Informed consent will be obtained from participants; 2) Collect baseline data and perform various assessments which include: a) 12-lead ECG; b) Infectious disease screening; c) Blood biochemistry, routine blood, urine routine, coagulation function; d) Blood pregnancy test (for female subjects); e) Hepatitis B virus and serology examination; f) Antinuclear antibody testing; g) Imaging examinations.
2. Treatment Period (Weeks 1 to 25): 1) Patients will receive ongoing nucleoside analogue treatment (NAs) throughout this stage; 2) Administer subcutaneous injections of the HBV monoclonal antibody HT-102 weekly for a total of 4 weeks (300 mg each time); 3) After treatment with HT-102, HBV serological and virological assessments will occur; 4) If serum HBsAg is below 10 IU/mL, proceed with therapeutic hepatitis B vaccine FD-001 (60 µg each time) every 4 weeks for a total of 6 doses; 5) If HBsAg is not below 10 IU/mL post HT-102, participants will enter the follow-up period directly.
3. Follow-up Phase (Weeks 25 to 49): 1) Continue with original nucleoside analogue treatment for HBV; 2) Conduct follow-up visits every 12 weeks; 3) Each visit will involve recording vital signs, conducting physical examinations, ECG, laboratory tests (as noted in safety indicators), and testing for HBV and immunological parameters.
* End of Study:
The study concludes once the follow-up of the last enrolled subject is completed, analyzing the collected data to evaluate efficacy and safety endpoints.
\- Note: Careful monitoring and adherence to protocols will be maintained to ensure participant safety and integrity of study data.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: